Evaluation of the Effectiveness of the "Aidant TLC" Program, Delivered in Person and Remotely, on the Well-being of Informal Caregivers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovation Alzheimer

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Psychoeducation

    Behavioral

    The 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

75 Participants
are divided into 3 treatment groups
Group A: In-person groupExperimental treatment 1 intervention
Group B: Online groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Depressive symptoms

Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-9);

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.
2

Self-efficacy

General Self-Efficacy Scale (GSE)

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.

Secondary outcomes

1

Caregiver burden

Zarit Burden Interview, short version; ZBI-12

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.
2

Anxiety

Generalized Anxiety Disorder; GAD-7

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.
3

Perceived caregiving benefits

Caregiver Reaction Assessment; CRA

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.
4

Empathy

Basic Empathy Scale; BES

Time frame
Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovation Alzheimer

Lead sponsor

Universite Cote d'Azur

Collaborator