About this trial
As the population ages in France, more people need help with daily activities. Family members and other informal caregivers often provide this support, which can be physically and emotionally demanding and may affect their well-being.
This study evaluates the "Aidant TLC (Thrive, Learn, Connect)" program, a support program designed to help caregivers better manage stress, emotions, and relationships. The program has been developed in the United States but has not yet been tested in France.
The goal of this study is to compare the effects of the program when delivered in two formats: online (remote) and in person. A third group of participants will not receive the program during the study period but will be offered it afterward.
A total of 75 caregivers will take part in the study. Participants will be randomly assigned to one of the three groups. The program consists of weekly group sessions over several weeks. Questionnaires will be used before and after the program to measure mood, stress, confidence, and overall well-being.
The results of this study will help determine whether this program is effective and whether it can be offered more widely to support caregivers, including those who may have difficulty accessing in-person services.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being an informal caregiver of an adult requiring assistance with activities of daily living
Providing at least 4 hours of care per week (broadly defined, including direct care as well as help with tasks such as medication management and bill payment)
French-speaking
Ability to travel (for the in-person intervention) to Nice or Biot (France)
Disqualifiers
Inability to provide informed consent.
Trial design
Parallel
Treatments tested in this trial
Psychoeducation
BehavioralThe Aidant TLC program is a 6-session therapeutic education program designed to develop emotional, interpersonal, and stress management skills in informal caregivers. https://caregivertlc.org/
Treatment groups
Trial outcomes
Primary outcomes
Depressive symptoms
Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-9);
Self-efficacy
General Self-Efficacy Scale (GSE)
Secondary outcomes
Caregiver burden
Zarit Burden Interview, short version; ZBI-12
Anxiety
Generalized Anxiety Disorder; GAD-7
Perceived caregiving benefits
Caregiver Reaction Assessment; CRA
Empathy
Basic Empathy Scale; BES
Sponsors and contacts
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Innovation Alzheimer
Lead sponsor
Universite Cote d'Azur
Collaborator