Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.
详细描述
Context: Since some of the ICs do not have the possibility to participate in face-to-face interventions, information and communication technologies are being increasingly used for a distance intervention. Research showing the benefit of a combined approach including psycho-social interventions for caregivers and Information and Communication Technologies (ICT) in the caring of Alzheimer's disease patients is actually growing. Main objective: To evaluate the efficacy of a a web-based psycho-educational program designed to support carers of AD patientsMethodology: This is a randomized clinical trial . 80 participants will be randomized in 2 parallel groups: The volunteers in the experimental condition (EC) should visit at least one time per week the website of program, during 12 weeks. Each week a new thematic is added to the website. b) The participants in the control group (CG) will receive a minimal intervention, and will have access to the Diapason program after their participation (six months). Caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory center participating in the trial.
Evaluation criteria:
Primary criteria:
- Perceived Stress Scale (PSS-14).
Secondary evaluation criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Family caregivers of AD patients DSM IV-TR (American Psychiatric Association 2004) or NINCDS/ADRDA (McKhann et al. 1984).
- •Age: over 18 years old
- •score 12 or over on the Perceived Stress Scale 14 items (PSS-14, Cohen) Need for information or help
- •Sign informed consent
排除标准
- •Professional or paid caregiver
- •Physical or mental disease incompatible with patient's management
- •Impossibility to participate in the educational program
- •Absence of perceived stress
- •Ongoing psychotherapy or a similar program in parallel
研究组 & 干预措施
Psycho-educational program
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
干预措施: psycho-social intervention based on a web-based psycho-educational program, called Diapason. (Behavioral)
Standard treatment
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
干预措施: Consultation in memory clinic (Behavioral)
结局指标
主要结局
Perceived stress
时间窗: every 3 months (between 0 and 6 months)
Stress perceived by the caregiver is measured by the French version of the Perceived Stress Scale, the version of 14 items from Cohen and colleagues (1983), traduced to by Bruchon-Schweitzer in 2002. The PSS-14 is a widely used self-reported scale, evaluating the general appraisal of stress in the last month. It consists in 14 items, which scores range from 0 (never) to 4 (very often). This scale has demonstrated a high reliability and validity in several studies. The total score range is 0-56. In this study CG and EC will perform the scale at baseline (month 0), at the end of intervention for EC (month 3) and follow-up (month 6). Participants from control group will receive an acces to the program at the end of the last visit (M6).
次要结局
- Revised Scale for Caregiving Self-Efficacy (RCSE)(every 3 months (between 0 and 6 months))
- Nottingham Health Profile (NPH)(every 3 months (between 0 and 6 months))
- ZARIT Burden Interview (BI)(every 3 months (between 0 and 6 months))
- Revised Memory and Behavior Problems Checklist (RMBPC)(every 3 months (between 0 and 6 months))
- Beck Depression Inventory (BDI-2)(every 3 months (between 0 and 6 months))