Primary CareISAMA-PPNCT06852326
Designing a Tailored Primary Care Intervention to Manage the Burden of Caring for Patients Living with Alzheimer's Disease (or a Related Dementia)
An observational study of Primary Care and Alzheimer Disease, run by University Hospital, Tours at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Care, Alzheimer Disease
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Nov 2024to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Professional carers
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CPTS Asclepios
Amboise, 37400
Alice Perrain, Dr
- Not yet recruiting
CPTS Pays d'Iroise
Saint-Renan, 29290
Manon Verbèque, Dr
- Recruiting
CPTS Est Cher
Sancergues, 18140
Alain Ichir, Dr
About this study
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.
Read the detailed description
First phase : determination of the intervention.
A list of proposed interventions drawn from the literature and the exploratory work will be proposed to panels of participants using the DELPHI-modified method : Rounds made up of a panel of carers, a panel of healthcare professionals in the field, and a panel of academic experts who have knowledge of the scientific literature on the subject as well as having clinical experience.
The method consists of proposing different intervention proposals and having them validated/modified using a Likert scale by scoring during different e-Delphi rounds (a paper version of the questionnaire will also be available). Following each Delphi round, a meeting will be organised with all the members of each panel to discuss the comments made during these rounds.
- Each item will be graded from 1 to 9 by each participant.
- Topics with a 70% score ≥ 7 are retained.
- Topics with a score of 70% ≤ 3 are eliminated.
- Topics scoring 70% between 4 and 6 are reformulated by the members of the scientific committee and reproposed in the following round.
It usually takes between 3-4 rounds to eliminate/validate themes.
Second phase : assessment of the acceptability of the conceived intervention.
Following this consensus, a complex intervention with several components will be determined and proposed by the scientific committee to the 3 participating CPTS (territorial professional health communities): the Asclepios and Est Cher CPTS (which had already participated in the previous exploratory studies) and the Iroise CPTS (naïve to any preliminary assessment of its needs in its territory). Quantitative data on the acceptability of the intervention will then be collected, namely :
- the number of carers who were offered or not offered the intervention
- the number of carers who benefited from the intervention in its entirety or by component
- the number of carers who refused or abandoned the intervention. Qualitative data on acceptability will also be collected through observations of voluntary carers and healthcare professionals and through interviews. Throughout the process of creating the intervention (from the Delphi rounds to the proposal of the intervention to the 3 participating CPTS), an exploration of the co-construction process and the acceptability of the intervention will be carried out using qualitative Focus Group (FG) interviews with each group involved (carers, healthcare professionals, university experts), then with each CPTS (carers and healthcare professionals from each CPTS). Depending on the results of this exploration, the intervention may be adapted by the scientific committee. This is a continuous process of evaluating the intervention, as recommended in the development of complex interventions.
The whole complex intervention thus determined will be reported using the TIDieR checklist model
- Conditions
- Primary Care, Alzheimer Disease
- Keywords
- care, caregiver
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group caregiver | Qualitative interviews and focus groups | |
| Group health professional | Qualitative interviews and focus groups | |
| Group academic expert | Qualitative interviews and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start21 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852326
- Sponsor's protocol ID
- DR240112 - ISAMA-PP
- Acronym
- ISAMA-PP
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Tailored Primary Care Intervention to Manage the Burden of Caring for Patients Living with Alzheimer's Disease (or a Related Dementia)
- ClinicalTrials.gov ID
- NCT06852326
- Acronym / sponsor ID
- ISAMA-PP / DR240112 - ISAMA-PP
- Conditions
- Primary Care, Alzheimer Disease
- Keywords
- care, caregiver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
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.
Detailed description
First phase : determination of the intervention.
A list of proposed interventions drawn from the literature and the exploratory work will be proposed to panels of participants using the DELPHI-modified method : Rounds made up of a panel of carers, a panel of healthcare professionals in the field, and a panel of academic experts who have knowledge of the scientific literature on the subject as well as having clinical experience.
The method consists of proposing different intervention proposals and having them validated/modified using a Likert scale by scoring during different e-Delphi rounds (a paper version of the questionnaire will also be available). Following each Delphi round, a meeting will be organised with all the members of each panel to discuss the comments made during these rounds.
- Each item will be graded from 1 to 9 by each participant.
- Topics with a 70% score ≥ 7 are retained.
- Topics with a score of 70% ≤ 3 are eliminated.
- Topics scoring 70% between 4 and 6 are reformulated by the members of the scientific committee and reproposed in the following round.
It usually takes between 3-4 rounds to eliminate/validate themes.
Second phase : assessment of the acceptability of the conceived intervention.
Following this consensus, a complex intervention with several components will be determined and proposed by the scientific committee to the 3 participating CPTS (territorial professional health communities): the Asclepios and Est Cher CPTS (which had already participated in the previous exploratory studies) and the Iroise CPTS (naïve to any preliminary assessment of its needs in its territory). Quantitative data on the acceptability of the intervention will then be collected, namely :
- the number of carers who were offered or not offered the intervention
- the number of carers who benefited from the intervention in its entirety or by component
- the number of carers who refused or abandoned the intervention. Qualitative data on acceptability will also be collected through observations of voluntary carers and healthcare professionals and through interviews. Throughout the process of creating the intervention (from the Delphi rounds to the proposal of the intervention to the 3 participating CPTS), an exploration of the co-construction process and the acceptability of the intervention will be carried out using qualitative Focus Group (FG) interviews with each group involved (carers, healthcare professionals, university experts), then with each CPTS (carers and healthcare professionals from each CPTS). Depending on the results of this exploration, the intervention may be adapted by the scientific committee. This is a continuous process of evaluating the intervention, as recommended in the development of complex interventions.
The whole complex intervention thus determined will be reported using the TIDieR checklist model
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group caregiver | – | –Qualitative interviews and focus groups |
| Group health professional | – | –Qualitative interviews and focus groups |
| Group academic expert | – | –Qualitative interviews and focus groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Professional carers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
description of the tailored primary care intervention to manage the burden of caring for patients living with Alzheimer's disease (or related dementia)
Time frame: 12 months
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.
1 secondary outcome
acceptability of the complex intervention by carers and healthcare professionals
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Care and Alzheimer Disease, run by University Hospital, Tours at 3 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clarisse DIBAO-DINA, Pr (02 47 36 60 19 ext. +33, clarisse.dibao-dina@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the tailored primary care intervention to manage the burden of caring for patients living with Alzheimer's disease (or related dementia) (time frame: 12 months). 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 28 Feb 2025.