NCT03361761

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

November 20, 2017

Last Update Submit

September 17, 2024

Conditions

Keywords

Chronic diseaseprecariousness and vulnerabilityHealth education

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months after the enrolment in the study

Secondary Outcomes (5)

  • impact of therapeutic patient education on residents' level of depression

    6 months after the enrolment in the study

  • impact of therapeutic patient education on residents' health status

    6 months after the enrolment in the study

  • impact of therapeutic patient education on residents' empowerment level

    6 months after the enrolment in the study

  • impact of therapeutic patient education on residents' perception of health status

    6 months after the enrolment in the study

  • impact of therapeutic patient education on residents' quality of life

    6 months after the enrolment in the study

Study Arms (2)

experimental

therapeutic coordination apartments with formalized/official Health education program

Other: Health education program

active comparator

therapeutic coordination apartments without formalized/official Health education program

Other: Health education program

Interventions

formalized/official Health education program

experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- residents admitted in therapeutic coordination apartments since October 2017;
  • with one or more chronic disease
  • over 18
  • accepting being enrolled in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Act Passerelle

La Roche-sur-Yon, 85000, France

Location

Act Acothe

Le Mans, 72100, France

Location

Act Aurore

Nantes, 44000, France

Location

CHU de Nantes

Nantes, 44093, France

Location

ACT Le Logis Montjoie

Nantes, 44300, France

Location

ACT Louis Guilloux

Rennes, 35200, France

Location

MeSH Terms

Conditions

Chronic DiseaseHealth Education

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Clément Le Glatin, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 5, 2017

Study Start

January 25, 2018

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations