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

2026年4月23日 更新者:Innovation Alzheimer

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.

研究概览

地位

招聘中

详细说明

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.

研究类型

介入性

注册 (估计的)

75

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:控制组
没有干预。
实验性的:In-person group
Psychoeducation group intervention delivered in-person
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/
实验性的:Online group
Psychoeducational group intervention delivered online
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/

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Depressive symptoms
大体时间: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.
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
大体时间: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.
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.

次要结果测量

结果测量
措施说明
大体时间
Caregiver burden
大体时间: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.
Zarit Burden Interview, short version; ZBI-12
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
大体时间: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.
Generalized Anxiety Disorder; GAD-7
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
大体时间: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.
Caregiver Reaction Assessment; CRA
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
大体时间: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.
Basic Empathy Scale; BES
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
大体时间: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.
French Apathy Motivation Index - f-AMI
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Valeria Manera, PhD、Universite Cote d'Azur
  • 首席研究员:Philippe Robert, Professor、Innovation Alzheimer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月5日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年4月11日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月23日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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