Clinical trial NCT05686486: Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
Official title: Impact of a Joint Practice of a Tai Chi Inspired Gymnastics Program on the Relationship Between Family Caregivers and Residents in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Relation, Family
Keywords: Dementia
Nursing homes
Psychosocial intervention
Family relationship
Family caregivers
Lead sponsor: Fondation Mederic Alzheimer
Sponsor class: OTHER
Collaborators: name: Malakoff-Humanis
name: Siel Bleu
First posted: 2023-01-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental design is a cluster randomised controlled study with three arms corresponding to three experimental conditions. Sixty dyads will be recruited for a total of 120 participants (60 family caregivers and 60 residents) divided into 12 groups.

9 nursing homes are participating.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this multicentre cluster randomised controlled trial is to evaluate the effects of a joint practice of a Tai Chi inspired gymnastics programme in nursing home on the relationship between family caregivers and residents living with mild to moderate dementia. The intervention consists of 24 sessions of Tai Chi inspired gymnastics programme for two one-hour sessions per week in a family caregiver-resident pair. The researchers will compare the practice of the intervention in pairs with a separate practice and with the absence of intervention to see if any effects are observed on the family caregiver-resident relationship. The hypotheses are as follows:

* Hypothesis 1: the relationship between family caregiver and resident will be judged better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.
* Hypothesis 2: signs of anxiety and depression in the family caregiver and resident should be lower after joint practice of a Tai Chi inspired gymnastics programme compared to separate practice and compared to no intervention.
* Hypothesis 3: the family caregivers' feeling of competence will be higher after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.
* Hypothesis 4: the quality of life of the residents will be better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.

Detailed description: An information letter was sent to nursing homes in the Lille region (France) to present the objectives of the study. The nursing homes that agreed to participate received additional information for implementing the study. Randomisation was carried out in clusters, i.e. the sites were randomised to one of the three experimental conditions. The randomisation was carried out using Excel (Microsoft Corporation, version 18.2110.13110.0). For each site, a random value was generated and then a rank was assigned for each value. The rank value was divided by three, corresponding to the number of experimental conditions. These values were then rounded up. Each site therefore has a value of "1", "2" or "3" corresponding to an experimental condition: "1" = arm #1; "2" = arm #2; and "3" = arm #3.

The investigators of the 9 participating nursing homes screened the residents and family caregivers according to inclusion, non-inclusion and exclusion criteria. The study was then presented to residents and family caregivers who met the criteria by giving them an information letter so that they could take time to consider whether to participate in the study, with a minimum two-week cooling-off period between the information and the written consent.

The socio-demographic data collected will concern for all participants: age; gender; level of education; relationship in the dyad; previous practice of Tai Chi; usual sports and leisure activities. For residents, the Mini Mental State Examination (MMSE) score will also be collected from the medical record of each included resident and must be less than six months old. If the MMSE score is older than six months, the nursing homes will be asked to carry out the MMSE.

Two assessments of the residents and family caregivers will be carried out before the intervention and two weeks after the intervention. The assessments will be carried out by psychologists who have been previously informed and/or trained in the use of the questionnaires and scales. The information and/or training will be done by telephone. Evaluations will be conducted blind, i.e. psychologists will not be aware of the experimental condition that will be assigned to each participant. Each evaluation will last between 30 minutes and 1 hour.

Data collection in the observation books will be carried out via a code assigned to each participant in a non-identifying manner. A table of correspondence between the participants' first and last names and the codes will be kept securely by the principal investigator at each site. Once the data collection is finalised, these tables will be deleted and the codes will not appear on the computer files used for data processing and statistical analysis.

Data will be stored in each nursing home for the duration of the study. Only authorised principal investigators will have access to the consent forms and observation books for the duration of the study, which will be anonymised. The external evaluators will have access to the observation books via by the principal investigators of each sites only during the evaluations.

The coordinating investigator will make monitoring visits to ensure the proper implementation of the study and the accuracy of the consent and data collection. The coordinating investigator will also be in regular contact by email and telephone with the principal investigator at each site.

The results of the tests and scales will be processed descriptively and analysed statistically with comparisons of means between the three experimental conditions. The results will also be analysed taking into account signs of anxiety, depression and the quality of the caregiver-caregiver relationship before the start of the study. The qualitative data will be analysed for content.

Eligibility criteria: Inclusion Criteria for the residents:

* Agreement of the resident and the family caregiver to participate in the study;
* Presence of neurocognitive disorders mentioned in the resident's file and objectified by a MMSE score between 16 and 25 out of 30;
* Presence in the nursing home for more than six months;
* Ability to attend the sessions;
* Ability to walk to the place of the intervention alone, with human or technical assistance.
* Medical advice indicating the possibility of practising the activity.

Exclusion Criteria for the residents:

* Refusal of the resident or of the family caregiver to continue the study;
* Alteration of the general state of health no longer allowing participation in the sessions and assessments;
* Hospitalization(s) that do not allow regular follow-up of the sessions and evaluations;
* Permanent leaving of the nursing home;
* Death.

Inclusion Criteria for the family caregivers:

* Medical certificate by the general practitioner indicating the possibility of carrying out the Tai Chi inspired gymnastics sessions;
* Family caregiver having frequent contact with the resident: spouse; child; brother/sister; cousin;
* Agreement of the family caregiver and the resident to participate in the study;
* Absence of neurocognitive disorders;
* Ability to attend the proposed sessions;
* Operational mobility to go to the intervention site.

Exclusion Criteria for the family caregivers:

* Refusal of the family caregiver or of the resident to continue the study;
* Alteration of the general state of health no longer allowing participation in the sessions and assessments;
* Hospitalization(s) that do not allow regular follow-up of the sessions and evaluations;
* Death.

Primary outcomes:
measure: Questionnaire of relationship between family caregivers and residents - Residents' point of view
timeFrame: Baseline
measure: Questionnaire of relationship between family caregivers and residents - Residents' point of view questionnaire
timeFrame: 2 weeks after the intervention
measure: Questionnaire of relationship between family caregivers and residents - Family caregivers' point of view
timeFrame: Baseline
measure: Questionnaire of relationship between family caregivers and residents - Family caregivers' point of view
timeFrame: 2 weeks after the intervention
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: Baseline and 2 weeks after the intervention
measure: Sense of Competence Questionnaire (QSC)
timeFrame: Baseline and 2 weeks after the intervention
measure: Quality of Life-Alzheimer's Disease scale in Nursing Homes (QOL-AD NH)
timeFrame: Baseline and 2 weeks after the intervention
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline
Other outcomes:
Locations:
city: Courchelettes
country: France
facility: Résidence Les Terrasses de la Scarpe
city: Lille
country: France
facility: EHPAD Afeji Edilys
city: Marpent
country: France
facility: EHPAD Korian Samara
city: Maubeuge
country: France
facility: EHPAD Afeji Les Tilleuls
Study officials:
affiliation: Fondation Mederic Alzheimer
name: Jean-Bernard Mabire, PhD
role: PRINCIPAL_INVESTIGATOR
References: