Early Accessible Person-centred Rehabilitation for Patients With Chronic Pain
EAPER-P
1 other identifier
interventional
220
1 country
1
Brief Summary
The goal of the research project EAPER-P is to evaluate PCC person-centred care (PCC) in the form of a combined eHealth and telephone support for patents with chronic pain. A developed PCC eHealth platform, together with person-centred telephone conversations, will be used as a tool to identify patients´ resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives. PCC in the form of a combined eHealth and telephone support will not replace, but instead be used as add on treatment to usual care (guideline directed care). In addition, a process evaluation of the intervention will be performed in order to evaluate the mechanisms behind the intervention and evaluate which parts of the interventions the participants find useful.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Aug 2021
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
August 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2028
ExpectedJuly 5, 2023
July 1, 2023
2 years
January 4, 2021
July 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite score of changes
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 6 months reduced sick leave and increased General self-efficacy scale by ≥ 5 units A patient is classified as deteriorated if: at 6 months increased sick leave or (if on full-time sick leave at inclusion reduced general self-efficacy by ≥ 5 units) Those who have neither deteriorated nor improved are considered unchanged General Self-Efficacy Scale: Possible scores range from 10 (low self-efficacy, worst) to 40 (high self-efficacy). Composite score possible scores: deteriorated (worst), unchanged, improved (best).
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
Secondary Outcomes (13)
Sick leave
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
General self-efficacy scale
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
EuroQol- 5 Dimensions (EQ-5D)
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
Hospital anxiety and depression scale (HADS)
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
Number of health care visits (Health care utilization)
Baseline, 3 months, 6 months, 1 year, 2 years, 5 years.
- +8 more secondary outcomes
Study Arms (2)
Person-centred care
EXPERIMENTALPCC in the form of a combined eHealth and structured telephone support combined with an eHealth support on top of usual care
Usual care
NO INTERVENTIONRegular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care center
Interventions
Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives
Eligibility Criteria
You may qualify if:
- Men and women 18-65 years old.
- Living with chronic, non-malignant, pain with any of the following diagnoses: M25, M54, M79 and R52
- On sick leave (full or part time) from paid professional work.
- Willing to participate
You may not qualify if:
- Full time sick leave \>24 months (part time sick leave \>24 months can be included).
- Severe impairment (cognitive or other) that prevents patient from using the eHealth support
- No registered address
- Not willing to participate
- Any severe disease with an expected survival \<12 months
- Ongoing documented diagnosis of alcohol or drug abuse
- Other severe disease that can interfere with follow-up or if the intervention is assessed as a burden
- Patient participating in another conflicting randomized study
- Patients not understanding spoken and written Swedish
- Patient not having access to a device with internet access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary care
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Wallström, PhD
Göteborg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 12, 2021
Study Start
August 15, 2021
Primary Completion
August 15, 2023
Study Completion (Estimated)
March 15, 2028
Last Updated
July 5, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share