Living Well With Chronic Pain (EPIO)

April 2, 2024 updated by: Lise Solberg Nes, Oslo University Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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.
Active Comparator: Experimental without introduction group and follow up phone calls
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
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
Other Names:
  • e-health intervention for chronic pain

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Vestre Viken Hospital Trust
University of Oslo
Mayo Clinic
The Research Council of Norway
University of Florida
Diakonhjemmet Hospital
University of Washington
University of Twente
University College of Southeast Norway
Drammen municipality, Norway

Investigators

  • Principal Investigator: Lise Solberg Nes, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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