Clinical trial NCT04254367: Empowering Patients to Participate in Health Care Decisions
Official title: Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Keywords: health literacy
sense of coherence
empowerment
patient education as topic
health-related quality of life
coping strategies
bio-psycho-social model
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2020-02-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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:• 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

Primary outcomes:
measure: Net days with sceduled activity
timeFrame: Change from base-line net days with scedulded activity at 6 months
Secondary outcomes:
measure: Net days with sceduled activity
timeFrame: Change from base-line net days with scedulded activity at 3 months
measure: Net days with sceduled activity
timeFrame: Change from base-line net days with scedulded activity at 12 months
measure: Health-related quality of life
timeFrame: Change from base-line scores EQ-5D at 3 months
measure: Health-related quality of life
timeFrame: Change from base-line scores EQ-5D at 6 months
measure: Health-related quality of life
timeFrame: Change from base-line scores EQ-5D at 12 months
measure: Sense of coherence (SOC)
timeFrame: Change from base-line scores SOC-13 scale at 3 months
measure: Sense of coherence (SOC)
timeFrame: Change from base-line scores SOC-13 scale at 6 months
measure: Sense of coherence (SOC)
timeFrame: Change from base-line scores SOC-13 scale at 12 months
measure: Health literacy
timeFrame: Change from base-line scores HLS-EU-Q16-SE scale at 3 months
measure: Health literacy
timeFrame: Change from base-line scores HLS-EU-Q16-SE scale at 6 months
measure: Health literacy
timeFrame: Change from base-line scores HLS-EU-Q16-SE scale at 12 months
measure: General self-efficacy
timeFrame: Change from base-line scores S-GSE scale at 3 months
measure: General self-efficacy
timeFrame: Change from base-line scores S-GSE scale at 6 months
measure: General self-efficacy
timeFrame: Change from base-line scores S-GSE scale at 12 months
measure: Social function
timeFrame: Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
measure: Social function
timeFrame: Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
measure: Social function
timeFrame: Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 3 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 6 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 12 months
measure: Job content
timeFrame: Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
measure: Job content
timeFrame: Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
measure: Job content
timeFrame: Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
measure: Total number of net and gross sick leave days
timeFrame: Change from base-line total number of net and gross sick leave days at 3 months
measure: Total number of net and gross sick leave days
timeFrame: Change from base-line total number of net and gross sick leave days at 6 months
measure: Total number of net and gross sick leave days
timeFrame: Change from base-line total number of net and gross sick leave days at 12 months
measure: Physical activity
timeFrame: Change from base-line scores LTPA (level of physical activity) scale at 3 months
measure: Physical activity
timeFrame: Change from base-line scores LTPAI (level of physical activity) scale at 6 months
measure: Physical activity
timeFrame: Change from base-line scores LTPAI (level of physical activity) scale at 12 months
measure: BMI
timeFrame: Change from base-line scores BMI at 3 months
measure: BMI
timeFrame: Change from base-line scores BMI at 6 months
measure: BMI
timeFrame: Change from base-line scores BMI at 12 months
measure: Symptoms of depression
timeFrame: Change from base-line scores MADRS-S scale at 3 months
measure: Symptoms of depression
timeFrame: Change from base-line scores MADRS-S scale at 6 months
measure: Symptoms of depression
timeFrame: Change from base-line scores MADRS-S scale at 12 months
measure: Symptoms of anxiety
timeFrame: Change from base-line scores GAD-7 scale at 3 months
measure: Symptoms of anxiety
timeFrame: Change from base-line scores GAD-7 scale at 6 months
measure: Symptoms of anxiety
timeFrame: Change from base-line scores GAD-7 scale at 12 months
measure: Symptoms of exhaustion
timeFrame: Change from base-line scores KEDS scale at 3 months
measure: Symptoms of exhaustion
timeFrame: Change from base-line scores KEDS scale at 6 months
measure: Symptoms of exhaustion
timeFrame: Change from base-line scores KEDS scale at 12 months
measure: Pain catastrophizing
timeFrame: Change from base-line scores pain catastrophizing scale at 3 months
measure: Pain catastrophizing
timeFrame: Change from base-line scores pain catastrophizing scale at 6 months
measure: Pain catastrophizing
timeFrame: Change from base-line scores pain catastrophizing scale at 12 months
measure: Participant pain
timeFrame: Change from base-line scores OMPSQ scale at 3 months
measure: Participant pain
timeFrame: Change from base-line scores OMPSQ scale at 6 months
measure: Participant pain
timeFrame: Change from base-line scores OMPSQ scale at 12 months
measure: Pain spreading
timeFrame: Change from base-line scores in number of painful body regions at 3 months
measure: Pain spreading
timeFrame: Change from base-line scores in number of painful body regions at 6 months
measure: Pain spreading
timeFrame: Change from base-line scores in number of painful body regions at 12 months
measure: Trust in own know-how
timeFrame: Change from base-line scores in questions about trust in own know-how and ability to improving health at 3 months
measure: Trust in own know-how
timeFrame: Change from base-line scores in questions about trust in own know-how and ability to improving health at 6 months
measure: Trust in own know-how
timeFrame: Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months
measure: Partners in health care
timeFrame: Change from base-line scores in questions about informed as a patient and being a partner in health care at 3 months
measure: Partners in health care
timeFrame: Change from base-line scores in questions about informed as a patient and being a partner in health care at 6 months
measure: Partners in health care
timeFrame: Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months
measure: Visits to primary health care
timeFrame: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 3 months
measure: Visits to primary health care
timeFrame: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 6 months
measure: Visits to primary health care
timeFrame: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dominique Hange
state: Region Vastra Gotaland
Study officials:
References: