Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03361761
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2017-11-20
Brief Title:
Impact of a Therapeutic Education Program on the Acceptance of Disease and Management of Care
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
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:
EDUPACT
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
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
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
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