Empowering Patients to Participate in Health Care Decisions

NCT04254367 | Completed

• 1 other identifier: Learn-to-Cope
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies.

Conditions

Rehabilitation

Keywords

health literacy; sense of coherence; empowerment; patient education as topic; health-related quality of life; coping strategies; bio-psycho-social model

Outcome Measures

Primary Outcomes (1)

• Net days with sceduled activity

  What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 6 months after baseline).

  Change from base-line net days with scedulded activity at 6 months

Secondary Outcomes (59)

• Net days with sceduled activity

  Change from base-line net days with scedulded activity at 3 months

• Net days with sceduled activity

  Change from base-line net days with scedulded activity at 12 months

• Health-related quality of life

  Change from base-line scores EQ-5D at 3 months

• Health-related quality of life

  Change from base-line scores EQ-5D at 6 months

• Health-related quality of life

  Change from base-line scores EQ-5D at 12 months

Study Arms (2)

Intervention group - experimental TAU + intervention

EXPERIMENTAL

Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.

Behavioral: Learn-to-Cope

TAU - no intervention

NO INTERVENTION

Treatment as usual following local routines on each primary care center

Interventions

Learn-to-Cope BEHAVIORAL

Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.

Intervention group - experimental TAU + intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients attending primary care centers included in the study.
• Aged 18-64 years
• Health-related impaired work ability \> 60 net days last 6 months

You may not qualify if:

• Serious mental disorder needing psychiatric specialist care
• Serious somatic disease a definite barrier to rehabilitation for a foreseeable future
• Cognitive impairment or not speaking /understanding Swedish

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Dominique Hange

Gothenburg, Region Vastra Gotaland, S-40530, Sweden

Location

Related Publications (1)

• Lofgren M, Nordeman L, Ariai N, Bjorkelund C, Rembeck G, Svenningsson I, Tornbom K, Hange D. Effect on work ability and health-related quality of life following an interactive patient education aiming to increase sense of coherence and health literacy - the LEARN-to-COPE cluster randomized trial. Scand J Prim Health Care. 2025 Dec;43(4):805-820. doi: 10.1080/02813432.2025.2507859. Epub 2025 May 22.

  PMID: 40405458 DERIVED

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator blinded of randomization results when informing PCCs about the study and PCCs blinded when selecting patients to the study. The PCCs were instructed to select 20-25 patients following the study's inclusion and exclusion criteria and among these select 12-14 patients to ask first. The other selected patients were to be asked if the first patients did not agree to participate in the study. After selection the PCCs were informed about randomization results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at PCC level. Around 30 PCCs and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 5, 2020
• Study Start: February 14, 2020
• Primary Completion: March 14, 2020
• Study Completion: June 30, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)