Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
340 participants
INTERVENTIONAL
2019-12-03
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
EPIO
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
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.
No interventions assigned to this group
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
EPIO
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
Interventions
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EPIO
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 18 years of age
* Able to write/read/speak Norwegian
* Have their own smart phone, PC or tablet
Exclusion Criteria
* Migraine
18 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
University of Oslo
OTHER
University College of Southeast Norway
OTHER
Diakonhjemmet Hospital
OTHER
Vestre Viken Hospital Trust
OTHER
Drammen municipality, Norway
UNKNOWN
Mayo Clinic
OTHER
University of Twente
OTHER
University of Washington
OTHER
University of Florida
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Lise Solberg Nes
Center Director, Head of Research
Principal Investigators
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Lise Solberg Nes, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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Bostrom K, Borosund E, Eide H, Varsi C, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Stavenes Stole H, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 25;25:e47284. doi: 10.2196/47284.
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.
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.
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.
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.
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.
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.
Related Links
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Study web page
Other Identifiers
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2018/799
Identifier Type: -
Identifier Source: org_study_id
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