About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
acceptability of the complex intervention by carers and healthcare professionals
For the 3 CPTS (territorial professional health communities) participating in the study, these outcomes will be calculated: Number of carers to whom the intervention was offered or not Number of carers who benefited from the intervention as a whole or by component Number of carers who refused or abandoned the intervention. Qualitative data on acceptability (verbatims comments and more) will also be collected through observations and interviews of voluntary carers and healthcare professionals.
Sponsors and contacts
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