The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
340
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
Oslo University Hospital
Oslo, Norway
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.
Time frame: Baseline, and at 3, 6, and 12 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline, and at 3, 6, and 12 months.