- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07558356
Evaluation of the Effectiveness of the "Aidant TLC" Program, Delivered in Person and Remotely, on the Well-being of Informal Caregivers (Aidant TLC)
Évaluation de l'efficacité du Programme " Aidant TLC " en présentiel et à Distance Sur le Bien-être Des Aidants Naturels
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Population aging is associated with a growing number of individuals experiencing loss of autonomy. Informal caregivers, most often family members or close relatives, play a central role in supporting dependent individuals at home. However, caregiving responsibilities are associated with substantial physical and psychological burden, including stress, emotional distress, and reduced quality of life. Interventions targeting psychosocial skills have shown promise in improving caregiver well-being. Online programs may improve accessibility, although their effectiveness can vary depending on implementation and participant engagement.
The Aidant TLC (Thrive, Learn, Connect) program is a psychosocial and educational intervention designed to enhance emotional regulation, interpersonal skills, and stress management among caregivers. Although developed and evaluated in the United States, this program has not yet been tested in France.
The primary objective of this randomized controlled trial is to compare changes in depressive symptoms and self-efficacy among three groups: (1) participants receiving the TLC intervention remotely, (2) participants receiving the TLC intervention in person, and (3) a control group receiving no intervention. Secondary objectives are to compare changes in caregiver burden, anxiety, perceived benefits of caregiving, empathy, and apathy across the three groups, and to assess adherence to the intervention in remote versus in-person formats.
This study is a three-arm randomized controlled trial including 75 participants (25 per group). Eligible participants are adult informal caregivers (≥18 years) providing at least 4 hours of care per week to a dependent adult, able to understand French, and with access to transportation (in-person group) or internet (remote group).
After baseline assessment (V0), participants will be randomized to one of the three groups using a computerized system. The intervention consists of weekly 2-hour sessions over 6 weeks, delivered either remotely or in person. The control group will not receive the intervention during the study period but will be offered participation after study completion.
Primary outcomes include changes in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) and self-efficacy (General Self-Efficacy Scale, GSE) from baseline to post-intervention (V1). Secondary outcomes include caregiver burden (Zarit Burden Interview-12), anxiety (GAD-7), perceived caregiving benefits (Caregiver Reaction Assessment), empathy (Basic Empathy Scale), and apathy (Apathy Motivation Index). Adherence will be assessed through session attendance, and acceptability will be evaluated via questionnaire in intervention groups.
Data will be analyzed using repeated-measures ANOVA with time (baseline, post-intervention) as a within-subject factor and group (remote, in-person, control) as a between-subject factor. Independent-samples t-tests will be used to compare adherence and acceptability between intervention groups.
The total study duration is 36 months, including 12 months for recruitment, 12 months for intervention delivery, and 12 months for data analysis and dissemination.
If effective, the Aidant TLC program could provide an accessible intervention to improve caregiver well-being, particularly for individuals with limited access to in-person support. No significant risks are anticipated.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Philippe Robert, Professor
- Número de teléfono: +33 4 92034770
- Correo electrónico: phil.robert15@orange.fr
Ubicaciones de estudio
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Biot, Francia
- Reclutamiento
- Créapolis
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Contacto:
- Philippe Robert
- Número de teléfono: +33 0497216930
- Correo electrónico: contact@jlncreapolis.fr
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Nice, Francia, 06100
- Reclutamiento
- Institut Claude Pompidou
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Contacto:
- Valeria Manera
- Número de teléfono: +33 0786541588
- Correo electrónico: valeria.manera@univ-cotedazur.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Inability to provide informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control
Sin intervención.
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Experimental: In-person group
Psychoeducation group intervention delivered in-person
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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/
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Experimental: Online group
Psychoeducational group intervention delivered online
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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/
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depressive symptoms
Periodo de tiempo: 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.
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Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-9);
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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.
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Self-efficacy
Periodo de tiempo: 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.
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General Self-Efficacy Scale (GSE)
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caregiver burden
Periodo de tiempo: 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.
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Zarit Burden Interview, short version; ZBI-12
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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.
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Anxiety
Periodo de tiempo: 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.
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Generalized Anxiety Disorder; GAD-7
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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.
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Perceived caregiving benefits
Periodo de tiempo: 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.
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Caregiver Reaction Assessment; CRA
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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.
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Empathy
Periodo de tiempo: 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.
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Basic Empathy Scale; BES
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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.
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Apathy
Periodo de tiempo: 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.
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French Apathy Motivation Index - f-AMI
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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.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Valeria Manera, PhD, Universite Cote d'Azur
- Investigador principal: Philippe Robert, Professor, Innovation Alzheimer
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2025-A01079-40
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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