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Clinical Trials/NCT03705104
NCT03705104
Active, not recruiting
Not Applicable

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

Oslo University Hospital1 site in 1 country340 target enrollmentDecember 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain, Widespread
Sponsor
Oslo University Hospital
Enrollment
340
Locations
1
Primary Endpoint
Brief Pain Inventory (BPI) (Short Form) - Assessing change
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 3, 2019
End Date
January 2030
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lise Solberg Nes

Center Director, Head of Research

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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