Living Well With Chronic Pain

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

Detailed Description
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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 to complete at baseline and at 3, 6 and 12 months. Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.

Official Title
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Living Well With Chronic Pain: Using Person-centered E-health Design to Support Self-management

Conditions
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Chronic Pain, Widespread

Intervention / Treatment
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* Behavioral: EPIO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPIO (e-health intervention)<br>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<br>* App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.<br>* Other names: e-health intervention for chronic pain;|
| No Intervention: treatment as usual<br>Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested. | |
| Active Comparator: Experimental without introduction group and follow up phone calls<br>One extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention | Behavioral: EPIO<br>* App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.<br>* Other names: e-health intervention for chronic pain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) (Short Form) - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing Scale (PCS) - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 
| Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 
| Self-Regulatory Fatigue 18 (SRF-18) - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 
| The Hospital Anxiety and Depression Scale (HADS) - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 
| System Usability Scale (SUS) | 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. | At 3 months | 
| RAND Health Related Quality of Life - Assessing change | 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. | Baseline, and at 3, 6, and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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App, Pain, Chronic Pain, Self-management, E-health, Appication, Intervention, Cognitive Behavioral Therapy, CBT, Acceptance and Commitment Therapy, ACT, Psychological well-being