Designing a Tailored Primary Care Intervention to Manage the Burden of Caring for Patients Living with Alzheimer's Disease (or a Related Dementia)

NCT06852326 | Recruiting

• 1 other identifier: DR240112 - ISAMA-PP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The design of the intervention is an ongoing process which will consist of two phases: a determination of the intervention using the Delphi-modified consensus method and an assessment of its acceptability, as described in the methodological recommendations of the Medical Research Council Guidance.

Conditions

Primary Care; Alzheimer Disease

Keywords

care; caregiver

Outcome Measures

Primary Outcomes (1)

• description of the tailored primary care intervention to manage the burden of caring for patients living with Alzheimer's disease (or related dementia)

  A list of interventions will be submitted to 3 panels of participants using the DELPHI method (panel of carers, panel of healthcare professionals and panel of academic experts). Each participant will rate his or her agreement with each of the proposals with a score ranging from 1 (strongly disagree) to 9 (strongly agree). For each proposal, the proportion of scores \>= 7, the proportion of scores between 4 and 6 and the proportion of scores \<=3 will be estimated. Proposals with at least 70% of ratings \>= 7 are retained. Proposals with at least 70% of scores \<= 3 are eliminated. Proposal with at least 70% of scores between 4 and 6 will be reformulated by the members of the scientific committee and reproposed in the following round. It usually takes between 3-4 rounds to eliminate/validate proposals: the complex intervention will be built on the consensus reached in theses rounds and reported using the TIDieR checklist model.

  12 months

Secondary Outcomes (1)

• acceptability of the complex intervention by carers and healthcare professionals

  6 months

Study Arms (3)

Group caregiver

Qualitative interviews and focus groups

Group health professional

Qualitative interviews and focus groups

Group academic expert

Qualitative interviews and focus groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Determining the intervention using the DELPHI-modified method, the 30 participants will be academic experts (10 people) and people from the 2 professional communities (CPTS) that took part in the exploratory studies, Asclepios and Est Cher (10 primary healthcare professionals and 10 carers). The 10 carers will have different characteristics depending on the level of dependency and the extent of the behavioural problems of the patient they are helping, and on their family status (parent, child or other). They will also come from the care areas of the 2 CPTS, Asclepios and Est Cher. Concerning the qualitative sociological exploration of the process of acceptability and co-construction of the intervention, the 30 participants will be academic experts (the 10 people identified above) and people from the 3 CPTS, Asclepios, Est Cher and Iroise who tested the conceived intervention (10 healthcare professionals and 10 carers).

You may qualify if:

• Healthcare professionals who are members of the 3 CPTSs included and who agree to participate
• Adult informal carers of patients living with Alzheimer's disease or a related dementia from the 3 CPTS who agree to participate
• University experts: general practitioners, geriatric mobile team doctor, advanced practice nurse, clinical psychologist, biostatistical methodologist. Some of them had already taken part in the steering committee for ISAMA's exploratory qualitative and quantitative studies.

You may not qualify if:

• \- Professional carers

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

CPTS Asclepios

Amboise, 37400, France

RECRUITING

CPTS Pays d'Iroise

Saint-Renan, 29290, France

NOT YET RECRUITING

CPTS Est Cher

Sancergues, 18140, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Clarisse DIBAO-DINA, Pr

CONTACT

02 47 36 60 19; clarisse.dibao-dina@univ-tours.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 28, 2025
• Study Start: November 21, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-01

Locations

FR (3)