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

NCT07558356 | Recruiting

• 1 other identifier: 2025-A01079-40
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Informal Caregiver

Keywords

Psychoeducational intervention; Informal caregiver; Online intervention; Group intervention; In-person intervention

Outcome Measures

Primary Outcomes (2)

• Depressive symptoms

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

  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.

• Self-efficacy

  General Self-Efficacy Scale (GSE)

  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 (5)

• Caregiver burden

  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.

• Anxiety

  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.

• Perceived caregiving benefits

  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.

• Empathy

  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.

• Apathy

  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.

Study Arms (3)

In-person group

EXPERIMENTAL

Psychoeducation group intervention delivered in-person

Behavioral: Psychoeducation

Online group

EXPERIMENTAL

Psychoeducational group intervention delivered online

Behavioral: Psychoeducation

Control group

NO INTERVENTION

No intervention.

Interventions

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/

In-person group; Online group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Access to the internet at home or in an easily accessible location (for the remote intervention).

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• Innovation Alzheimer: lead
• Universite Cote d'Azur: collaborator

Study Sites (2)

Créapolis

Biot, France

RECRUITING

Institut Claude Pompidou

Nice, 06100, France

RECRUITING

Study Officials

• Valeria Manera, PhD

  Université Cote d'Azur

  PRINCIPAL INVESTIGATOR

• Philippe Robert, Professor

  Innovation Alzheimer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Robert, Professor

CONTACT

+33 4 92034770; phil.robert15@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 30, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)