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N-of-1 Trials Using mHealth in Chronic Pain (PREEMPT)

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ClinicalTrials.gov Identifier: NCT02116621
Recruitment Status : Completed
First Posted : April 17, 2014
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE April 17, 2014
Results First Submitted Date  ICMJE February 27, 2018
Results First Posted Date  ICMJE May 25, 2018
Last Update Posted Date May 25, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: baseline, 26 weeks ]
Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: baseline, 26 weeks ]
Pain interference measured with PROMIS 8-item short form
Change History Complete list of historical versions of study NCT02116621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
  • Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • Longitudinal change from baseline in pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale at 13, 26 and 52 weeks [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Pain interference measured with PROMIS 8-item short form
  • Longitudinal change from baseline in pain intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale at 13, 26 and 52 weeks [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Pain intensity measured with PROMIS 3a short form
  • Longitudinal change from baseline in Health-Related Quality of Life (HRQL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at 13, 26 and 52 weeks [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    HRQL measured with 10 item PROMIS Global Health scale
  • Longitudinal change from baseline in participatory decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys at 13, 26 and 52 weeks [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    Participatory decision-making measured with 4 questions from the CAHPS survey assessing patient-provider discussions on starting/stopping medications
  • Longitudinal change from baseline on the Pain Treatment Satisfaction Scale (PTSS) at 13, 26 and 52 weeks [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    Pain Treatment Satisfaction Scale questions include 5 questions assessing pain and its treatment; 5 questions assessing medical care; and 8 questions about current pain medications.
  • Longitudinal change from baseline in analgesic adherence on the Pain Medication in Primary Care Patient Questionnaire at 13, 26 and 52 weeks [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Four questions assessing adherence to medications from the Pain Medication in Primary Care Patient Questionnaire
  • Longitudinal change from baseline in patient-provider relationship on the Trust in Physician scale at 13, 26 and 52 weeks [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2018)
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
  • Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
  • Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks [ Time Frame: 26 weeks ]
    Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
  • Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
  • Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
  • Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
  • Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
  • Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
  • Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
  • Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
Original Other Pre-specified Outcome Measures
 (submitted: April 16, 2014)
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Pain intensity measured with PROMIS 3a short form
  • Change from baseline in Health-Related Quality of Life (HRQL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at 26 weeks [ Time Frame: Baseline, 26 weeks ]
    HRQL measured with 10 item PROMIS Global Health scale
  • Change from baseline in participatory decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys at 26 weeks [ Time Frame: Baseline, 26 weeks ]
    Participatory decision-making measured with 4 questions from the CAHPS survey assessing patient-provider discussions on starting/stopping medications
  • Change from baseline on the Pain Treatment Satisfaction Scale (PTSS) at 26 weeks [ Time Frame: Baseline, 26 weeks ]
    Pain Treatment Satisfaction Scale questions include 5 questions assessing pain and its treatment; 5 questions assessing medical care; and 8 questions about current pain medications
  • Change from baseline in analgesic adherence on the Pain Medication in Primary Care Patient Questionnaire at 26 weeks [ Time Frame: Baseline, 26 weeks ]
    Four questions assessing adherence to medications from the Pain Medication in Primary Care Patient Questionnaire
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale
  • Change from baseline in pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale at 13 weeks [ Time Frame: Baseline, 13 weeks ]
    Pain interference measured with PROMIS 8-item short form
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Pain intensity measured with PROMIS 3a short form
  • Change from baseline in Health-Related Quality of Life (HRQL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at 13 weeks [ Time Frame: Baseline, 13 weeks ]
    HRQL measured with 10 item PROMIS Global Health scale
  • Change from baseline in participatory decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys at 13 weeks [ Time Frame: Baseline, 13 weeks ]
    Participatory decision-making measured with 4 questions from the CAHPS survey assessing patient-provider discussions on starting/stopping medications
  • Change from baseline on the Pain Treatment Satisfaction Scale (PTSS) at 13 weeks [ Time Frame: Baseline, 13 weeks ]
    Pain Treatment Satisfaction Scale questions include 5 questions assessing pain and its treatment; 5 questions assessing medical care; and 8 questions about current pain medications
  • Change from baseline in analgesic adherence on the Pain Medication in Primary Care Patient Questionnaire at 13 weeks [ Time Frame: Baseline, 13 weeks ]
    Four questions assessing adherence to medications from the Pain Medication in Primary Care Patient Questionnaire
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale
  • Change from baseline in pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale at 52 weeks [ Time Frame: Baseline, 52 weeks ]
    Pain interference measured with PROMIS 8-item short form
  • Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Pain intensity measured with PROMIS 3a short form
  • Change from baseline in Health-Related Quality of Life (HRQL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at 52 weeks [ Time Frame: Baseline, 52 weeks ]
    HRQL measured with 10 item PROMIS Global Health scale
  • Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Participatory decision-making measured with 4 questions from the CAHPS survey assessing patient-provider discussions on starting/stopping medications
  • Change from baseline on the Pain Treatment Satisfaction Scale (PTSS) at 52 weeks [ Time Frame: Baseline, 52 weeks ]
    Pain Treatment Satisfaction Scale questions include 5 questions assessing pain and its treatment; 5 questions assessing medical care; and 8 questions about current pain medications
  • Change from baseline in analgesic adherence on the Pain Medication in Primary Care Patient Questionnaire at 52 weeks [ Time Frame: Baseline, 52 weeks ]
    Four questions assessing adherence to medications from the Pain Medication in Primary Care Patient Questionnaire
  • Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    Patient trust in physician measured with 11-item Trust in Physician Scale
 
Descriptive Information
Brief Title  ICMJE N-of-1 Trials Using mHealth in Chronic Pain
Official Title  ICMJE N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)
Brief Summary

Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment.

The purpose of the PREEMPT Study is to test whether using a mobile phone application ("Trialist app") that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Musculoskeletal Pain
  • Chronic Pain
Intervention  ICMJE
  • Behavioral: Trialist Intervention
    Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
    Other Names:
    • Trialist smartphone app
    • mobile health
  • Device: smartphone
Study Arms  ICMJE
  • Experimental: Trialist Intervention
    Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.
    Interventions:
    • Behavioral: Trialist Intervention
    • Device: smartphone
  • No Intervention: Control-Usual Care
    Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
215
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2014)
244
Actual Study Completion Date  ICMJE May 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale
  • Age 18-75 years
  • Own web-enabled Android or iOS phone with data plan
  • In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments
  • Ability to speak and read English

Exclusion Criteria:

  • Treated with surgery, radiation or chemotherapy for cancer in past 5 years
  • Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety
  • Pregnant or breastfeeding
  • Dementia, bipolar disorder, schizophrenia, active suicidality
  • Current alcohol or prescription drug abuse; history of disruptive behavior
  • Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02116621
Other Study ID Numbers  ICMJE 496804
R01NR001938 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Richard L Kravitz, MD, MSPH University of California, Davis
PRS Account University of California, Davis
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP