An observational study in Chronic Disease, sponsored by Nantes University Hospital. Completed at 6 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Nantes University Hospital · Observational
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).
Context: The significant increase in the number of patients with chronic disease in France in recent years has led to the implementation of therapeutic patient education programs to develop their independence and quality of life in regard to their illness. Despite this growth, socio-economic status, cultural level or education still remain significant obstacles to access to Health education for patients with psychosocial vulnerability. In this context, the implementation of an Health education approach in specific living devices called therapeutic coordination apartments (TCA) was tested in 2011. The TCAs are medico-social establishments offering accommodation and temporary medical-psycho-social support to people in a situation of precariousness affected by at least one disabling chronic pathology in order to restore their autonomy. However, only two TCAs currently offer Health Education programs integrated with their activities. These two structures were supported by the Transverse Unit for Therapeutic Education (UTET) of the University Hospital of Nantes for the construction of these programs, now authorized by the Regional Health Agency of the Pays de la Loire and effective for 18 months.
Objective: The overall objective of the project is to evaluate the added value of integrated Health Education in TCA care. The main objective will be to compare, at 6 months of care, the perception of the burden of treatment among TCA residents integrating the practice of Health Education versus control group TCA residents. The burden of treatment is defined as the perception of the constraints on daily life related to all of what a person does to heal. The secondary objectives will be, on the one hand, to evaluate the impact of Health Education in TCA on: the state of health of the residents and the perception of their state of health, their quality of life and their empowerment. On the other hand, they will study the benefits, the brakes and the levers perceived by the teams that have integrated the Health Education in their activity.
METHOD: This is a pragmatic, controlled, quasi-experimental intervention trial comparing two groups of residents: one experimental group in two TCAs incorporating Health Education and one group of 4 control TCAs. The study will be mixed, qualitative and quantitative with residents and professionals. All new volunteer residents entering TCA for 1 year will be solicited (approximately 5 to 15 per TCA). The burden of treatment will be assessed for each group after 1 month in TCA (baseline) and then at 6 months by the Treatment Burden Questionnaire. The secondary criteria will be explored quantitatively at 1 month, 6 months and 12-18 months by the EQ-5D questionnaire, the 2 global items of the WHO-QOL Brief and the MAP13, as well as the count of hospitalizations and Resident emergencies, in relation to their chronic pathology. A qualitative survey consisting of individual interviews with residents and focus groups with Therapeutic Coordination Apartments' teams practicing Health Education. The total duration of the study is 36 months.
Perspectives: By showing a potential added value for the residents of the integration of Health Education within the TCAs, this project will confirm the interest to cross specific practices of care in TCA (adapted to the precarious people, having a low level of health literacy) with Health Education practices tailored to people with multiple pathologies. The study of the perceptions of teams integrating Health Education into their practice may encourage the diffusion of these still rare programs in these structures.
781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.
This study's enrollment of 66 is below the median of 461 across 188 observational studies indexed under Chronic Disease.
Browse Chronic Disease studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Compared within Chronic Disease, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
therapeutic coordination apartments with formalized/official Health education program
Other: Health education program
therapeutic coordination apartments without formalized/official Health education program
Other: Health education program
formalized/official Health education program
non formalized/official Health education program
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)
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' level of depression
comparison between assessments at baseline and after 6 months - (self-assessed by residents with Hospital Anxiety and Depression scale :HAD scale)
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' health status
comparison between assessments at baseline and after 6 months - (assessed with number of admission in emergency unit, number of hospitalizations)
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' empowerment level
comparison between assessments at baseline and after 6 months - (self-assessed by residents with Patient Actvation Measure survey (MAP13))
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' perception of health status
comparison between assessments at baseline and after 6 months - (self-assessed by residents with The World Healyh Organisation Quality of Life survey (WHO-QoL))
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' quality of life
comparison between assessments at baseline and after 6 months - (self-assessed by residents with Euroqol 5 dimensions survey (EQ-5D))
Time frame: 6 months after the enrolment in the study
Ran from Jan 2018 to primary completion in Dec 2021, 46 months.
Of 86 non-industry observational studies under Chronic Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's 46 months is above that.
Counting every sponsor, half of 91 studies reached it within 37 months; a quarter within 14.
Chronic Disease covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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