Empowering Patients to Participate in Health Care Decisions

NCT ID: NCT04254367

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2023-06-30

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.

Detailed Description

Chronic poor health and impaired work ability entails both personal suffering and considerable social costs. Poverty, homelessness, difficulties to handle complex issues, and maltreatment may affect health outcomes in the long run. Both sense of coherence (SOC) and the ability to understand health-related information (health literacy) influences personal coping strategies and thus the motivation to participate in health care and rehabilitation, which is known to have a positive impact on health outcome. The purpose of this study is to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care and 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. 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 Primary Care Center (PCC) level. Around 30 Primary Care Centers 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. The study is expected to show whether patient education in study circles aiming to increase health literacy and sense of coherence has a causal effect on perceived health, ability and function, independence and quality of life for patients with long-term health-related disabilities and passive coping strategies compared to TAU.

The research subjects will answer all questionnaires in a web based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, iPad or computer. Individual web links to the questionnaires will be distributed via e-mail. Research subject identity is replaced with individual codes in esMaker. The research assistant will be in charge of the CodeKey and responsible for distributing the web links and for reminding the research subjects to fill in the questionnaires.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group - experimental TAU + intervention

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.

Group Type: EXPERIMENTAL

Learn-to-Cope

Intervention Type: 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.

TAU - no intervention

Treatment as usual following local routines on each primary care center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn-to-Cope

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients attending primary care centers included in the study.

• Aged 18-64 years
• Health-related impaired work ability > 60 net days last 6 months

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dominique Hange

Gothenburg, Region Vastra Gotaland, Sweden

Countries

Sweden

References

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 May 22:1-16. doi: 10.1080/02813432.2025.2507859. Online ahead of print.

Reference Type: DERIVED

PMID: 40405458 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Learn-to-Cope

Identifier Type: -

Identifier Source: org_study_id