Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04254367
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2020-01-21
Brief Title:
Empowering Patients to Participate in Health Care Decisions
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None