Chronic DiseaseEDUPACTNCT03361761
Impact of a Therapeutic Education Program on the Acceptance of Disease and Management of Care
An observational study of Chronic Disease, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Health education program
- How many people
- 66 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Jan 2018to 10 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- residents admitted in therapeutic coordination apartments since October 2017;
- with one or more chronic disease
- over 18
- accepting being enrolled in the study
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Act Passerelle
La Roche-sur-Yon, 85000
Act Acothe
Le Mans, 72100
Act Aurore
Nantes, 44000
CHU de Nantes
Nantes, 44093
ACT Le Logis Montjoie
Nantes, 44300
ACT Louis Guilloux
Rennes, 35200
About this study
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
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).
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Health education program
- Keywords
- Chronic disease, precariousness and vulnerability, Health education
- Medical subject headings
- Chronic Disease, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education programOther
formalized/official Health education program
Health education programOther
non formalized/official Health education program
| Study group | Role | What they receive |
|---|---|---|
| experimental | therapeutic coordination apartments with formalized/official Health education program Receives: Other: Health education program | |
| active comparator | therapeutic coordination apartments without formalized/official Health education program Receives: Other: Health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months after the enrolment in the study
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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))
Measured: 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))
Measured: 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))
Measured: 6 months after the enrolment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start25 Jan 2018
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France
- Responsible party
- Sponsor
- Investigators
- Clément Le Glatin, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361761
- Sponsor's protocol ID
- RC17_0108
- Acronym
- EDUPACT
- Status last verified
- Sep 2024
- First submitted
- 20 Nov 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03361761
- Acronym / sponsor ID
- EDUPACT / RC17_0108
- Conditions
- Chronic Disease
- Keywords
- Chronic disease, precariousness and vulnerability, Health education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | – | Other: Health education programtherapeutic coordination apartments with formalized/official Health education program |
| active comparator | – | Other: Health education programtherapeutic coordination apartments without formalized/official Health education program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- residents admitted in therapeutic coordination apartments since October 2017;
- with one or more chronic disease
- over 18
- accepting being enrolled in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education programformalized/official Health education program | Other | experimental |
| Health education programnon formalized/official Health education program | Other | active comparator |
Primary outcome
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
Time frame: 6 months after the enrolment in the study
The Baseline assessment and the 6 months assessment of Treatment burden score (assessed with TBQ:Treatment burden survey)
5 secondary outcomes
impact of therapeutic patient education on residents' level of depression
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' health status
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' empowerment level
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' perception of health status
Time frame: 6 months after the enrolment in the study
impact of therapeutic patient education on residents' quality of life
Time frame: 6 months after the enrolment in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clément Le Glatin, PH principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months after the enrolment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.