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Active, Not Recruiting

NCT Number: NCT03705104

Living Well with Chronic Pain

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain, Widespread Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Chronic Pain Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPIO

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EPIO

Important dates

Study start
2019
Primary completion
2025
Study completion
2030
First posted
Oct 15, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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