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Impact of a Therapeutic Education Program on the Acceptance of Disease and Management of Care (EDUPACT)

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ClinicalTrials.gov Identifier: NCT03361761
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Institut de Recherche en Santé Publique, France
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date November 20, 2017
First Posted Date December 5, 2017
Last Update Posted Date February 9, 2018
Actual Study Start Date January 8, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2018)
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)
Original Primary Outcome Measures
 (submitted: November 28, 2017)
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 questionnaire)
Change History Complete list of historical versions of study NCT03361761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 8, 2018)
  • impact of therapeutic patient education on residents' level of depression [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with Hospital Anxiety and Depression scale :HAD scale)
  • impact of therapeutic patient education on residents' health status [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (assessed with number of admission in emergency unit, number of hospitalizations)
  • impact of therapeutic patient education on residents' empowerment level [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with Patient Actvation Measure survey (MAP13))
  • impact of therapeutic patient education on residents' perception of health status [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with The World Healyh Organisation Quality of Life survey (WHO-QoL))
  • impact of therapeutic patient education on residents' quality of life [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with Euroqol 5 dimensions survey (EQ-5D))
Original Secondary Outcome Measures
 (submitted: November 28, 2017)
  • impact of therapeutic patient education on residents' quality of life [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with EQ-5D questionnaire)
  • impact of therapeutic patient education on residents' perception of health status [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with WHO-QoL questionnaire)
  • impact of therapeutic patient education on residents' empowerment level [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with MAP13 questionnaire)
  • impact of therapeutic patient education on residents' health status [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (assessed with number of admission in emergency unit, number of hospitalizarions)
  • impact of therapeutic patient education on residents' level of depression [ Time Frame: 6 months after the enrolment in the study ]
    comparison between assessments at baseline and after 6 months - (self-assessed by residents with HAD scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Chronic Disease
Intervention
  • Other: Health education program
    formalized/official Health education program
  • Other: Health education program
    non formalized/official Health education program
Study Groups/Cohorts
  • experimental
    therapeutic coordination apartments with formalized/official Health education program
    Intervention: Other: Health education program
  • active comparator
    therapeutic coordination apartments without formalized/official Health education program
    Intervention: Other: Health education program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2017)
68
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clément Le Glatin, PH 02.40.84.75.94 clement.leglatin@chu-nantes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03361761
Other Study ID Numbers RC17_0108
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Institut de Recherche en Santé Publique, France
Investigators
Principal Investigator: Clément Le Glatin, PH CHU de Nantes
PRS Account Nantes University Hospital
Verification Date November 2017