Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Net days with sceduled activity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Acute crisis
- •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
Outcomes
Primary Outcomes
Net days with sceduled activity
Time Frame: Change from base-line net days with scedulded activity at 6 months
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).
Secondary Outcomes
- Sense of coherence (SOC)(Change from base-line scores SOC-13 scale at 12 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 12 months)
- General self-efficacy(Change from base-line scores S-GSE scale at 12 months)
- Social function(Change from base-line scores sub scale "Social function" of RAND-36 at 12 months)
- Health literacy(Change from base-line scores HLS-EU-Q16-SE scale at 12 months)
- Work ability(Change from base-line scores WAI scale at 12 months)
- Job content(Change from base-line scores Karasek Job Content Questionnaire scale at 12 months)
- Total number of net and gross sick leave days(Change from base-line total number of net and gross sick leave days at 12 months)
- Physical activity(Change from base-line scores LTPAI (level of physical activity) scale at 12 months)
- BMI(Change from base-line scores BMI at 12 months)
- Symptoms of exhaustion(Change from base-line scores KEDS scale at 12 months)
- Symptoms of depression(Change from base-line scores MADRS-S scale at 12 months)
- Symptoms of anxiety(Change from base-line scores GAD-7 scale at 12 months)
- Participant pain(Change from base-line scores OMPSQ scale at 12 months)
- Pain spreading(Change from base-line scores in number of painful body regions at 12 months)
- Trust in own know-how(Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months)
- Partners in health care(Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months)
- Visits to primary health care(Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months)
- Pain catastrophizing(Change from base-line scores pain catastrophizing scale at 12 months)