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Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation (HH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269239
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sara Nowakowski, Baylor College of Medicine

Brief Summary:
This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Condition or disease Intervention/treatment Phase
Insomnia Pain Osteoarthritis, Knee Osteoarthritis, Hip Behavioral: Healthy Habits Behavioral: Sleep Habits Not Applicable

Detailed Description:
Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), in-hospital, post-hospital, post-intervention and at a 6 month follow-up visit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to either the a healthy habits group or a sleep habits group.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Healthy Habits
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
Behavioral: Healthy Habits
Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.

Sleep Habits
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
Behavioral: Sleep Habits
Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.




Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 7-14 days before scheduled surgery ]
    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 10 is optimal to detect clinical levels of insomnia.

  2. Insomnia Severity Index (ISI) [ Time Frame: 7-14 days after hospital discharge ]
    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 10 is optimal to detect clinical levels of insomnia.

  3. Insomnia Severity Index (ISI) [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 10 is optimal to detect clinical levels of insomnia.

  4. Insomnia Severity Index (ISI) [ Time Frame: 6 months after completing the intervention ]
    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 10 is optimal to detect clinical levels of insomnia.

  5. Wrist actigraphy [ Time Frame: 7-14 days before scheduled surgery ]
    A wearable device will be used to measure participant sleep over seven days.

  6. Wrist actigraphy [ Time Frame: 7-14 days after hospital discharge ]
    A wearable device will be used to measure participant sleep over seven days.

  7. Wrist actigraphy [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    A wearable device will be used to measure participant sleep over seven days.

  8. Wrist actigraphy [ Time Frame: 6 months after completing the intervention ]
    A wearable device will be used to measure participant sleep over seven days.


Secondary Outcome Measures :
  1. PROMIS Physical Function (short form) [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  2. PROMIS Physical Function (short form) [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  3. PROMIS Physical Function (short form) [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  4. PROMIS Physical Function (short form) [ Time Frame: 6 months after completing the intervention ]
    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  5. PROMIS Mobility [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  6. PROMIS Mobility [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  7. PROMIS Mobility [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  8. PROMIS Mobility [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  9. NIH Toolbox Motor Tests [ Time Frame: 7-14 days before scheduled surgery ]
    Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).

  10. NIH Toolbox Motor Tests [ Time Frame: 7-14 days after hospital discharge ]
    Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).

  11. NIH Toolbox Motor Tests [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).

  12. NIH Toolbox Motor Tests [ Time Frame: 6 months after completing the intervention ]
    Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).

  13. PROMIS Applied Cognitive Abilities [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  14. PROMIS Applied Cognitive Abilities [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  15. PROMIS Applied Cognitive Abilities [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  16. PROMIS Applied Cognitive Abilities [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  17. PROMIS Applied Cognitive Abilities - General Concerns [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  18. PROMIS Applied Cognitive Abilities - General Concerns [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  19. PROMIS Applied Cognitive Abilities - General Concerns [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  20. PROMIS Applied Cognitive Abilities - General Concerns [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  21. NIH Tool Box Cognition Tests [ Time Frame: 7-14 days before scheduled surgery ]
    NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.

  22. NIH Tool Box Cognition Tests [ Time Frame: 7-14 days after hospital discharge ]
    NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.

  23. NIH Tool Box Cognition Tests [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.

  24. NIH Tool Box Cognition Tests [ Time Frame: 6 months after completing the intervention ]
    NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.

  25. Activities of Daily Living (ADLs) [ Time Frame: 7-14 days before scheduled surgery ]
    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  26. Activities of Daily Living (ADLs) [ Time Frame: 7-14 days after hospital discharge ]
    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  27. Activities of Daily Living (ADLs) [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  28. Activities of Daily Living (ADLs) [ Time Frame: 6 months after completing the intervention ]
    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  29. Instrumental ADLs (IADL) scale [ Time Frame: 7-14 days before scheduled surgery ]
    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  30. Instrumental ADLs (IADL) scale [ Time Frame: 7-14 days after hospital discharge ]
    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  31. Instrumental ADLs (IADL) scale [ Time Frame: 7-14 days after completing the 8 week intervention period and ]
    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  32. Instrumental ADLs (IADL) scale [ Time Frame: 6 months after completing the intervention ]
    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  33. Sleep Diary [ Time Frame: 7-14 days before scheduled surgery ]
    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  34. Sleep Diary [ Time Frame: 7-14 days after hospital discharge ]
    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  35. Sleep Diary [ Time Frame: During the 8 week intervention ]
    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  36. Sleep Diary [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  37. Sleep Diary [ Time Frame: 6 months after completing the intervention ]
    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  38. Knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: 7-14 days before scheduled surgery ]
    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  39. Knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: 6 months after completing intervention ]
    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  40. Hip disability and osteoarthritis outcome score (HOOS) [ Time Frame: 7-14 days before scheduled surgery ]
    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  41. Hip disability and osteoarthritis outcome score (HOOS) [ Time Frame: 6 months after completing intervention ]
    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  42. StepWatch [ Time Frame: 7-14 days before scheduled surgery ]
    A wearable device will measure physical activity over a seven day period.

  43. StepWatch [ Time Frame: 7-14 days after hospital discharge ]
    A wearable device will measure physical activity over a seven day period.

  44. StepWatch [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    A wearable device will measure physical activity over a seven day period.

  45. StepWatch [ Time Frame: 6 months after completing the intervention ]
    A wearable device will measure physical activity over a seven day period.


Other Outcome Measures:
  1. PROMIS Pain Intensity [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  2. PROMIS Pain Intensity [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  3. PROMIS Pain Intensity [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  4. PROMIS Pain Intensity [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  5. PROMIS Pain Interference [ Time Frame: 7-14 days before schedule surgery ]
    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  6. PROMIS Pain Interference [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  7. PROMIS Pain Interference [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  8. PROMIS Pain Interference [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  9. PROMIS Fatigue [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  10. PROMIS Fatigue [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  11. PROMIS Fatigue [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  12. PROMIS Fatigue [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  13. PROMIS Emotional Distress-Depressesion [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  14. PROMIS Emotional Distress-Depressesion [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  15. PROMIS Emotional Distress-Depressesion [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  16. PROMIS Emotional Distress-Depressesion [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  17. PROMIS Psychosocial Illness Impact - Negative [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  18. PROMIS Psychosocial Illness Impact - Negative [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  19. PROMIS Psychosocial Illness Impact - Negative [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  20. PROMIS Psychosocial Illness Impact - Negative [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  21. PROMIS Satisfaction with Social Roles and Activities [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  22. PROMIS Satisfaction with Social Roles and Activities [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  23. PROMIS Satisfaction with Social Roles and Activities [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  24. PROMIS Satisfaction with Social Roles and Activities [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  25. PROMIS Ability to Participate in Social Roles and Activity [ Time Frame: 7-14 days before scheduled surgery ]
    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  26. PROMIS Ability to Participate in Social Roles and Activity [ Time Frame: 7-14 days after hospital discharge ]
    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  27. PROMIS Ability to Participate in Social Roles and Activity [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  28. PROMIS Ability to Participate in Social Roles and Activity [ Time Frame: 6 months after completing the intervention ]
    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  29. Rehabilitation Attendance [ Time Frame: From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks. ]
    Weekly rehabilitation attendance will be measured via patient self-report.

  30. Plasma IL-6 [ Time Frame: 7-14 days before scheduled surgery ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  31. Plasma IL-6 [ Time Frame: 7-14 days after hospital discharge ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  32. Plasma IL-6 [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  33. Plasma IL-6 [ Time Frame: 6 months after completing the intervention ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  34. Plasma CRP [ Time Frame: 7-14 days before scheduled surgery ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  35. Plasma CRP [ Time Frame: 7-14 days after hospital discharge ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  36. Plasma CRP [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  37. Plasma CRP [ Time Frame: 6 months after completing the intervention ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  38. Plasma VWF [ Time Frame: 7-14 days before scheduled surgery ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  39. Plasma VWF [ Time Frame: 7-14 days after hospital discharge ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  40. Plasma VWF [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  41. Plasma VWF [ Time Frame: 6 months after completing the intervention ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  42. Plasma TNFalpha [ Time Frame: 7-14 days before scheduled surgery ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  43. Plasma TNFalpha [ Time Frame: 7-14 days after hospital discharge ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  44. Plasma TNFalpha [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  45. Plasma TNFalpha [ Time Frame: 6 months after completing the intervention ]
    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  46. Electronic Medical Record [ Time Frame: 7-14 days before scheduled surgery ]
    Electronic Medical Record will be reviewed using a structured review form. Key descriptive (co) variables that will be assessed include: medical diagnoses, medications, rehabilitation attendance and participation.

  47. Electronic Medical Record [ Time Frame: 7-14 days after hospital discharge ]
    Electronic Medical Record will be reviewed using a structured review form. Key descriptive (co) variables that will be assessed include: medical diagnoses, medications, rehabilitation attendance and participation.

  48. Electronic Medical Record [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Electronic Medical Record will be reviewed using a structured review form. Key descriptive (co) variables that will be assessed include: medical diagnoses, medications, rehabilitation attendance and participation.

  49. Electronic Medical Record [ Time Frame: 6 months after completing the intervention ]
    Electronic Medical Record will be reviewed using a structured review form. Key descriptive (co) variables that will be assessed include: medical diagnoses, medications, rehabilitation attendance and participation.

  50. Medication Monitoring Form [ Time Frame: 7-14 days before schedule surgery ]
    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  51. Medication Monitoring Form [ Time Frame: 7-14 days after hospital discharge ]
    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  52. Medication Monitoring Form [ Time Frame: 7-14 days after completing the 8 week intervention period ]
    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  53. Medication Monitoring Form [ Time Frame: 6 months after completing the intervention ]
    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  54. Treatment Expectation Questionnaire [ Time Frame: Immediately prior to beginning the intervention ]
    This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).

  55. Treatment Satisfaction Questionnaire [ Time Frame: Immediately following the completion of the intervention ]
    Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients (ages 55+) planning on having a hip or knee arthroplasty.
  2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
  3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
  4. Score ≥10 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
  5. Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria:

  1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
  2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
  3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
  4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
  5. Must live within 30 miles of recruiting site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269239


Contacts
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Contact: Sara Nowakowski, PhD 713-791-1414 ext 10307 sara.nowakowski@bcm.edu
Contact: Emily Lantz, PhD ejlantz@utmb.edu

Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Sara Nowakowski, PhD Baylor College of Medicine

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Responsible Party: Sara Nowakowski, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04269239    
Other Study ID Numbers: H - 45617 HealthyHab
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Nowakowski, Baylor College of Medicine:
Knee Arthroplasty
Hip Arthroplasty
Rehabilitation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases