Clinical trial NCT03705104: Living Well with Chronic Pain
Official title: Living Well with Chronic Pain: Using Person-centered E-health Design to Support Self-management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain, Widespread
Keywords: Pain
Chronic Pain
Self-management
E-health
Appication
App
Intervention
Cognitive Behavioral Therapy
CBT
Acceptance and Commitment Therapy
ACT
Psychological well-being
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Oslo
name: University College of Southeast Norway
name: Diakonhjemmet Hospital
name: Vestre Viken Hospital Trust
name: Drammen municipality, Norway
name: Mayo Clinic
name: University of Twente
name: University of Washington
name: University of Florida
First posted: 2018-10-15
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* Migraine

Primary outcomes:
measure: Brief Pain Inventory (BPI) (Short Form) - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS) - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
measure: Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
measure: Self-Regulatory Fatigue 18 (SRF-18) - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
measure: The Hospital Anxiety and Depression Scale (HADS) - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
measure: System Usability Scale (SUS)
timeFrame: At 3 months
measure: RAND Health Related Quality of Life - Assessing change
timeFrame: Baseline, and at 3, 6, and 12 months.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lise Solberg Nes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bostrom K, Varsi C, Eide H, Borosund E, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Nordang EF, Stubhaug A, Nes LS. Engaging with EPIO, a digital pain self-management program: a qualitative study. BMC Health Serv Res. 2022 Apr 29;22(1):577. doi: 10.1186/s12913-022-07963-x.
citation: Eiken AG, Nordanger DO, Solberg Nes L, Varsi C. Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. JMIR Form Res. 2022 Mar 16;6(3):e34458. doi: 10.2196/34458.
citation: Varsi C, Ledel Solem IK, Eide H, Borosund E, Kristjansdottir OB, Heldal K, Waxenberg LB, Weiss KE, Schreurs KMG, Morrison EJ, Stubhaug A, Solberg Nes L. Health care providers' experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: a qualitative study. BMC Health Serv Res. 2021 Mar 25;21(1):275. doi: 10.1186/s12913-021-06278-7.
citation: Bostrom K, Borosund E, Varsi C, Eide H, Flakk Nordang E, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study. JMIR Form Res. 2020 Oct 23;4(10):e23893. doi: 10.2196/23893.
citation: Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Borosund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Overby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889.
citation: Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Borosund E, Haaland-Overby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205.