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Living Well With Chronic Pain (EPIO)

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ClinicalTrials.gov Identifier: NCT03705104
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
The Research Council of Norway
University of Oslo
University College of Southeast Norway
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
Drammen municipality, Norway
Mayo Clinic
University of Twente
University of Washington
University of Florida
Information provided by (Responsible Party):
Lise Solberg Nes, Oslo University Hospital

Brief Summary:
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.

Condition or disease Intervention/treatment Phase
Chronic Pain, Widespread Behavioral: EPIO Not Applicable

Detailed Description:

Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.

The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.

The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. . Both groups will receive outcome measures at baseline, immediately post intervention (or maximum 8 weeks), at 6 months and at 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Living Well With Chronic Pain: Using Person-centered E-health Design to Support Self-management
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: EPIO (e-health intervention)
Participants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises.
Behavioral: EPIO
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
Other Name: e-health intervention for chronic pain

No Intervention: treatment as usual
Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested.



Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) (Short Form) - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]

    9 item scale measuring pain interference on function. Using this measure, respondents rate their worst, least, average, and current pain intensity and also rate the degree to which pain interferes with 7 domains of functioning (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) on a scale of 0 to 10.

    There is no scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.


  2. RAND Health Related Quality of Life - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]
    36 item scale measuring health related quality of life. The RAND-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.


Secondary Outcome Measures :
  1. Pain Catastrophizing Scale (PCS) - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]
    13 item scale measuring helplessness, magnification and rumination. Patients rate items on a scale from 0 (not at all) to 4 (all the time). The total score range for the PCS is 0 to 52, with higher scores reflecting higher degrees of catastrophizing.

  2. Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]
    8 item scale measuring pain acceptance. It is scored on a 7-point Likert scale (0 = never true; 6 = always true). Higher scores reflect higher acceptance of pain.

  3. Self-Regulatory Fatigue 18 (SRF-18) - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]
    18 item scale measuring self-regulatory capacity with cognitive, emotional, and behavioral components. Items are scored on a 5-point Likert scale (1 to 5). The obtainable score range is 18 to 90, with higher numbers reflecting higher SRF.

  4. The Hospital Anxiety and Depression Scale (HADS) - Assessing change [ Time Frame: Baseline, immediately post intervention (immediately post intervention or max 8 weeks), follow up at 6, and 12 months. ]
    14 item scale measuring anxiety and depression. Respondents are asked to indicate which of 4 response options (rated from 0-3; score range, 0-42) comes closest to describing how they have been feeling in the previous week for each item. Scores from 0-7 on the subscales are regarded as being in the normal range; a score of 11 or higher indicates a probable presence of a mood disorder, and a score of 8-10 is suggestive of the presence of the state.

  5. System Usability Scale (SUS) [ Time Frame: Immediately post intervention or max 8 weeks. ]
    1o item scale measuring usability, with five response options for respondents; from Strongly agree to Strongly disagree. The obtainable score range is 25 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pain (pain > 3 months)
  • > 18 years of age
  • Able to write/read/speak Norwegian
  • Have their own smart phone, PC or tablet

Exclusion Criteria:

  • Cancer related pain
  • Migraine

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): NCT03705104


Contacts
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Contact: Cecilie Varsi, PhD +4790856339 cecilie.varsi@rr-research.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Lise Solberg Nes, PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
University of Oslo
University College of Southeast Norway
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
Drammen municipality, Norway
Mayo Clinic
University of Twente
University of Washington
University of Florida
Investigators
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Principal Investigator: Lise Solberg Nes, PhD Oslo University Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lise Solberg Nes, Center Director, Head of Research, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03705104     History of Changes
Other Study ID Numbers: 2018/799
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Lise Solberg Nes, Oslo University Hospital:
Pain
Chronic Pain
Self-management
E-health
Appication
App
Intervention
Cognitive Behavioral Therapy
CBT
Acceptance and Commitment Therapy
ACT
Psychological well-being

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms