Impact of a Therapeutic Education Program on the Acceptance of Disease and Management of Care
EDUPACT
1 other identifier
observational
66
1 country
6
Brief Summary
Through its patient-centered approach and focus on developing coping skills and coping strategies, Health Education could be an effective approach in therapeutic coordination apartments to reduce the perceived treatment burden among people in precarious situations with one or more chronic diseases. Decreasing perception of burden would improve their quality of life and adherence to treatment. The general hypothesis explored in this project is that the experience of the disease, the perception of the burden of treatment, the autonomy and the quality of life of the residents improve more importantly in therapeutic coordination apartments having implemented a formalized and structured Health Education approach (experimental group) than in those who did not set up formalized and structured Health Education approach (control group).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedStudy Start
First participant enrolled
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2021
CompletedSeptember 19, 2024
September 1, 2024
3.9 years
November 20, 2017
September 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
evaluation of the impact of a formal approach to therapeutic patient education on the intensity of the treatment burden perceived by residents compared to therapeutic coordination apartment residents not benefiting from an authorized program
The Baseline assessment and the 6 months assessment of Treatment burden score (assessed with TBQ:Treatment burden survey)
6 months after the enrolment in the study
Secondary Outcomes (5)
impact of therapeutic patient education on residents' level of depression
6 months after the enrolment in the study
impact of therapeutic patient education on residents' health status
6 months after the enrolment in the study
impact of therapeutic patient education on residents' empowerment level
6 months after the enrolment in the study
impact of therapeutic patient education on residents' perception of health status
6 months after the enrolment in the study
impact of therapeutic patient education on residents' quality of life
6 months after the enrolment in the study
Study Arms (2)
experimental
therapeutic coordination apartments with formalized/official Health education program
active comparator
therapeutic coordination apartments without formalized/official Health education program
Interventions
Eligibility Criteria
The study focuses on patients in a precarious situation with chronic pathology (one or more) that are admitted in a Therapeutic Coordination Apartment (TCA). TCA's residents are women or men, French or coming from abroad, needing medical-social welfare support to manage their disease, treatments, everyday life, and approaches.
You may qualify if:
- \- residents admitted in therapeutic coordination apartments since October 2017;
- with one or more chronic disease
- over 18
- accepting being enrolled in the study
You may not qualify if:
- residents in situation of great psychological and / or physical suffering
- Residents with diseases incompatible with questionnaires (cognitive disorders, impaired comprehension or severe speech disorder)
- Residents non-francophone without interpreter
- Residents under justice protective measure
- Investigator declining the participation of a resident for any substantial reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Act Passerelle
La Roche-sur-Yon, 85000, France
Act Acothe
Le Mans, 72100, France
Act Aurore
Nantes, 44000, France
CHU de Nantes
Nantes, 44093, France
ACT Le Logis Montjoie
Nantes, 44300, France
ACT Louis Guilloux
Rennes, 35200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clément Le Glatin, PH
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
December 5, 2017
Study Start
January 25, 2018
Primary Completion
December 10, 2021
Study Completion
December 10, 2021
Last Updated
September 19, 2024
Record last verified: 2024-09