Clinical trial NCT03361761: Impact of a Therapeutic Education Program on the Acceptance of Disease and Management of Care
Official title: Impact of a Therapeutic Education Program Specifically Adapted to the Precarious People Supported in Therapeutic Coordination Apartments on the Acceptance of Their Disease and the Management of Their Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Keywords: Chronic disease
precariousness and vulnerability
Health education
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Publique, France
First posted: 2017-12-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- residents admitted in therapeutic coordination apartments since October 2017;

* with one or more chronic disease
* over 18
* accepting being enrolled in the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 6 months after the enrolment in the study
Secondary outcomes:
measure: impact of therapeutic patient education on residents' level of depression
timeFrame: 6 months after the enrolment in the study
measure: impact of therapeutic patient education on residents' health status
timeFrame: 6 months after the enrolment in the study
measure: impact of therapeutic patient education on residents' empowerment level
timeFrame: 6 months after the enrolment in the study
measure: impact of therapeutic patient education on residents' perception of health status
timeFrame: 6 months after the enrolment in the study
measure: impact of therapeutic patient education on residents' quality of life
timeFrame: 6 months after the enrolment in the study
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Act Passerelle
city: Le Mans
country: France
facility: Act Acothe
city: Nantes
country: France
facility: Act Aurore
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: ACT Le Logis Montjoie
city: Rennes
country: France
facility: ACT Louis Guilloux
Study officials:
affiliation: Nantes University Hospital
name: Clément Le Glatin, PH
role: PRINCIPAL_INVESTIGATOR
References: