NCT03705104

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Dec 2019Jan 2030

First Submitted

Initial submission to the registry

September 20, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6.1 years

First QC Date

September 20, 2018

Last Update Submit

March 18, 2025

Conditions

Chronic Pain, Widespread

Keywords

PainChronic PainSelf-managementE-healthAppicationAppInterventionCognitive Behavioral TherapyCBTAcceptance and Commitment TherapyACTPsychological well-being

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory (BPI) (Short Form) - Assessing change

    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 Outcomes (6)

  • Pain Catastrophizing Scale (PCS) - 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.

  • The Hospital Anxiety and Depression Scale (HADS) - Assessing change

    Baseline, and at 3, 6, and 12 months.

  • System Usability Scale (SUS)

    At 3 months

  • +1 more secondary outcomes

Study Arms (3)

EPIO (e-health intervention)

EXPERIMENTAL

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

treatment as usual

NO INTERVENTION

Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested.

Experimental without introduction group and follow up phone calls

ACTIVE COMPARATOR

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

Interventions

EPIOBEHAVIORAL

App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.

Also known as: e-health intervention for chronic pain
EPIO (e-health intervention)Experimental without introduction group and follow up phone calls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pain (pain \> 3 months)
  • \> 18 years of age
  • Able to write/read/speak Norwegian
  • Have their own smart phone, PC or tablet

You may not qualify if:

  • Cancer related pain
  • Migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (7)

  • 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.

    PMID: 37624622DERIVED

  • 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.

    PMID: 35488295DERIVED

  • 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.

    PMID: 35293866DERIVED

  • 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.

    PMID: 33766028DERIVED

  • 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.

    PMID: 33094734DERIVED

  • 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.

    PMID: 31961331DERIVED

  • 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.

    PMID: 30877780DERIVED

Related Links

MeSH Terms

Conditions

Chronic PainPainAlzheimer DiseasePsychological Well-Being

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Lise Solberg Nes, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center Director, Head of Research

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 15, 2018

Study Start

December 3, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)