Geriatric CareMAYFAIRNCT06080126
Developing and Implementing Meaningful Activities Facilitators in Geriatric Short Stay
A study testing Intervention MAF in people with Geriatric Care, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Older people are particularly vulnerable to adverse effects of hospitalization, which can compromise their functional autonomy. The onset of confusion, loss of mobility or malnutrition is largely related to the context of hospitalization itself, which creates stressful situations for patients in addition to the acute… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Care
- What is being tested?
- Intervention MAF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Oct 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged 65 and over
- admitted to a geriatric short-stay hospital for > 72 hours
- Considered "at risk of complications related to hospitalisation": at least two of the following criteria:
- Clinical Frailty Scale (Rockwood Clinical Frailty Score
- At least one ADL-IADL dependency,
- Presence of known cognitive impairment,
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- Patient confused on admission,
- History of confusional syndrome on previous hospitalisation or use of medication,
- Anxiety-depression (history or current pathology),
- Repeated falls (>2 in a year) or fear of falling,
- Risk of sarcopenia (Score >4 on the SARC-F questionnaire
- Presenting undernutrition or a risk of undernutrition (according to medical assessment, e.g. low BMI, anorexia, recent weight loss).
- Patient having been informed of the study and having signed an informed consent (for patients under guardianship, the consent of the guardian will be requested). For patients under guardianship, the patient will sign the consent in the presence of the guardian.
- Patient who understands and speaks French
- Patient affiliated to a social security scheme
Who cannot join
- Patient in palliative care for a terminal disease
- Re-hospitalised patients already included during a previous stay
- Patients under court protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Geriatric Short Stay Department - Unit 3C of the Charpennes Hospital
Lyon, 69100
Antoine CRUSSARD-GARNIER, MD, 4.72.43.21.27 ext. +33, antoine.garnier-crussard@chu-lyon.fr
University Department of Geriatric Medicine, Centre Hospitalier Lyon Sud
Lyon, 69495
Thomas GILBERT, MD, 4.78.86.49.39 ext. +33, thomas.gilbert@chu-lyon.fr
Stephanie POUPON-BOURDY, 6.61.23.43.28, stephanie.poupon-bourdy@chu-lyon.fr
About this study
Official title: Developing and Implementing Meaningful Activities Facilitators in Short-stay Geriatric Unit to Prevent Geriatric Complication - A Feasibility Study
Older people are particularly vulnerable to adverse effects of hospitalization, which can compromise their functional autonomy. The onset of confusion, loss of mobility or malnutrition is largely related to the context of hospitalization itself, which creates stressful situations for patients in addition to the acute pathology: change in the usual living environment, lack of human and reassuring interactions, lack of mobility related to the pathology or caused by the use of barriers or restraints. These geriatric complications can be prevented. Programs involving the intervention of volunteers or dedicated professionals with hospitalized patients have been developed. These "Meaningful Activities Facilitators" (MAF) have the task of preventing or limiting the deleterious effects of hospitalization on the older people, in particular by stimulating eating and walking, and by practicing social activities in line with the patient's lifestyle habits. This system has been set up in geriatric short-stay wards in the United Kingdom, where MAFs, who received specific training, are integrated into the care team and work with patients at risk. The integration of these MAFs has shown a reduction in the incidence and duration of delirium episodes, the use of psychotropic drugs, and the use of restraint. A study currently underway in Australia aims to reduce hospital-acquired complications through a program of mobilization, nutrition, and engagement of patients in constructive activities (the "Eat, Walk, Engage" program) implemented by a trained MAFs. The investigators hypothesis is that the implementation of MAFs in geriatric short-stay wards will reduce the incidence of geriatric complications associated with hospitalization.
Objectives: The investigators objective is to study the feasibility and acceptability of integrating MAFs into the care teams of two geriatric short-stay services in France. The investigators will evaluate the adaptations to be proposed to the MAF model to make it relevant in our context from the point of view of patients, their relatives and professionals, and will study the effect of this intervention on the occurrence of complications and the functioning of the teams, its implementation and its costs.
Perspectives: The results of this study will allow us to define if the MAFs intervention is feasible and acceptable in the French context, and if so, to propose an intervention model adapted to our context.
Read the detailed description
Methods: The project will be carried out in 2 phases guided by the Medical Research Council's (MRC) recommendations for the development and evaluation of complex health interventions. Phase 1: Adaptation of the MAFs intervention to our context, combining literature review, non-participant observation, semi-structured interviews, and coconstruction workshops. Phase 2: Feasiblity testing : A quasi-experimental feasibility "before and after" study will be conducted in two geriatric short-stay services on 380 patients: "before" period over 4 months (inclusion of 160 hospitalized patients constituting the control group), recruitment and training of 2 MAFs, implementation of the intervention, "after" period over 4 months (inclusion of 160 hospitalized patients constituting the intervention group). The patients will be included at admission and followed up during the hospital stay. The data collected concern the occurrence of complications during the stay, the quality of life at work of the professionals, and in the "after" period, the acceptability and fidelity of the MAFs intervention, according to the point of view of the MAFs, the professionals and the patients/relatives. These criteria will be collected through monitoring of the MAFs activity (logbook, medical records) and semi-structured interviews. The impact of the integration of the MAFs on the functioning, team cohesion and collaboration will be studied.
The results will allow us to propose phase 3 of the MRC recommendations, a multicenter randomized controlled evaluation in clusters, informed by the results for the content of the intervention, the implementation strategies, the choice of the primary endpoint, the inclusion criteria of the population, the calculation of the sample size and the study procedures (inclusion, data collection).
- Conditions
- Geriatric Care
- Being tested
- Control: per usual practice, Intervention MAF
- Keywords
- Meaningful activities facilitators, geriatric service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: per usual practiceOther
160 patients were included as per usual practice.
Intervention MAFOther
160 patients were included with MAF intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Not described Receives: Other: Control: per usual practice |
| Intervention | Other | Not described Receives: Other: Intervention MAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of implementing meaningful activities facilitators (MAF) in a French short stay geriatric unit, from the perspective of professionals, MAF and patients/relatives.
Criteria to conclude on feasibility will be the fulfilment of the following criteria during the intervention period (MAF implementation):
- employment of two MAFs (one per participating unit, 0.5FTE),
- SATIN and EEPMT Questionnaire
Measured: From the implementation of a meaningful activities facilitators for a period of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Oct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric CareStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in a 2-phase approach corresponding to the 2 successive phases of the MRC guidance: * Phase 1: The adaptation of the intervention to our context will be based on a literature review and a qualitative study. * Phase 2: The feasibility and acceptability of the intervention will be assessed during a quasi-experimental before and after study conducted in two short-stay geriatric units.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080126
- Sponsor's protocol ID
- 69HCL22_0726
- Other IDs
- 2023-A00490-45
- Acronym
- MAYFAIR
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing Meaningful Activities Facilitators in Short-stay Geriatric Unit to Prevent Geriatric Complication - A Feasibility Study
- ClinicalTrials.gov ID
- NCT06080126
- Acronym / sponsor ID
- MAYFAIR / 69HCL22_0726
- Conditions
- Geriatric Care
- Keywords
- Meaningful activities facilitators, geriatric service
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
Older people are particularly vulnerable to adverse effects of hospitalization, which can compromise their functional autonomy. The onset of confusion, loss of mobility or malnutrition is largely related to the context of hospitalization itself, which creates stressful situations for patients in addition to the acute pathology: change in the usual living environment, lack of human and reassuring interactions, lack of mobility related to the pathology or caused by the use of barriers or restraints. These geriatric complications can be prevented. Programs involving the intervention of volunteers or dedicated professionals with hospitalized patients have been developed. These "Meaningful Activities Facilitators" (MAF) have the task of preventing or limiting the deleterious effects of hospitalization on the older people, in particular by stimulating eating and walking, and by practicing social activities in line with the patient's lifestyle habits. This system has been set up in geriatric short-stay wards in the United Kingdom, where MAFs, who received specific training, are integrated into the care team and work with patients at risk. The integration of these MAFs has shown a reduction in the incidence and duration of delirium episodes, the use of psychotropic drugs, and the use of restraint. A study currently underway in Australia aims to reduce hospital-acquired complications through a program of mobilization, nutrition, and engagement of patients in constructive activities (the "Eat, Walk, Engage" program) implemented by a trained MAFs. The investigators hypothesis is that the implementation of MAFs in geriatric short-stay wards will reduce the incidence of geriatric complications associated with hospitalization.
Objectives: The investigators objective is to study the feasibility and acceptability of integrating MAFs into the care teams of two geriatric short-stay services in France. The investigators will evaluate the adaptations to be proposed to the MAF model to make it relevant in our context from the point of view of patients, their relatives and professionals, and will study the effect of this intervention on the occurrence of complications and the functioning of the teams, its implementation and its costs.
Perspectives: The results of this study will allow us to define if the MAFs intervention is feasible and acceptable in the French context, and if so, to propose an intervention model adapted to our context.
Detailed description
Methods: The project will be carried out in 2 phases guided by the Medical Research Council's (MRC) recommendations for the development and evaluation of complex health interventions. Phase 1: Adaptation of the MAFs intervention to our context, combining literature review, non-participant observation, semi-structured interviews, and coconstruction workshops. Phase 2: Feasiblity testing : A quasi-experimental feasibility "before and after" study will be conducted in two geriatric short-stay services on 380 patients: "before" period over 4 months (inclusion of 160 hospitalized patients constituting the control group), recruitment and training of 2 MAFs, implementation of the intervention, "after" period over 4 months (inclusion of 160 hospitalized patients constituting the intervention group). The patients will be included at admission and followed up during the hospital stay. The data collected concern the occurrence of complications during the stay, the quality of life at work of the professionals, and in the "after" period, the acceptability and fidelity of the MAFs intervention, according to the point of view of the MAFs, the professionals and the patients/relatives. These criteria will be collected through monitoring of the MAFs activity (logbook, medical records) and semi-structured interviews. The impact of the integration of the MAFs on the functioning, team cohesion and collaboration will be studied.
The results will allow us to propose phase 3 of the MRC recommendations, a multicenter randomized controlled evaluation in clusters, informed by the results for the content of the intervention, the implementation strategies, the choice of the primary endpoint, the inclusion criteria of the population, the calculation of the sample size and the study procedures (inclusion, data collection).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted in a 2-phase approach corresponding to the 2 successive phases of the MRC guidance: * Phase 1: The adaptation of the intervention to our context will be based on a literature review and a qualitative study. * Phase 2: The feasibility and acceptability of the intervention will be assessed during a quasi-experimental before and after study conducted in two short-stay geriatric units.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Control: per usual practice |
| Intervention | Other | Other: Intervention MAF |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Patient aged 65 and over
- admitted to a geriatric short-stay hospital for > 72 hours
- Considered "at risk of complications related to hospitalisation": at least two of the following criteria:
- Patient having been informed of the study and having signed an informed consent (for patients under guardianship, the consent of the guardian will be requested). For patients under guardianship, the patient will sign the consent in the presence of the guardian.
- Patient who understands and speaks French
Key exclusion criteria (3 listed)
- Patient in palliative care for a terminal disease
- Re-hospitalised patients already included during a previous stay
- Patients under court protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control: per usual practice160 patients were included as per usual practice. | Other | Control |
| Intervention MAF160 patients were included with MAF intervention. | Other | Intervention |
Primary outcome
Feasibility and acceptability of implementing meaningful activities facilitators (MAF) in a French short stay geriatric unit, from the perspective of professionals, MAF and patients/relatives.
Time frame: From the implementation of a meaningful activities facilitators for a period of 4 months.
Criteria to conclude on feasibility will be the fulfilment of the following criteria during the intervention period (MAF implementation): * employment of two MAFs (one per participating unit, 0.5FTE), * SATIN and EEPMT Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention MAF in people with Geriatric Care, run by Hospices Civils de Lyon at 2 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 15 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas GILBERT, MD (4.78.86.49.39 ext. +33, thomas.gilbert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of implementing meaningful activities facilitators (MAF) in a French short stay geriatric unit, from the perspective of professionals, MAF and patients/relatives. (time frame: From the implementation of a meaningful activities facilitators for a period of 4 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 17 Oct 2023.