Living Well With Chronic Pain (EPIO)
|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: NCT03705104|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain, Widespread||Behavioral: EPIO||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Cecilie Varsi, PhDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Contact: Lise Solberg Nes, PhD|
|Principal Investigator:||Lise Solberg Nes, PhD||Oslo University Hospital|