Behavioral Intervention to Reduce Resistance in Those Attending Adult Day Care Centers: PROCENDIAS Study. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- disruptive behaviors
研究概览
简要总结
Adult Day Care Centers (ADCC) offer important relief and rest services for family caregivers. However, some caregivers report that behavioral and psychological symptoms of dementia (BPSD) arise when they prepare dependents for the ADCC, especially when they have dementia. This issue increases stress for caregivers and contributes to a worsening of their mental health and quality of life. The present study evaluates the effectiveness of a behavioral intervention program aimed at reducing the reluctance of the dependent to attend the ADCC. We hope that reducing resistance will have a positive influence on the mental health of caregivers.
详细描述
Randomized controlled trial. The protocol was performed in accordance with the SPIRIT 2013 Statement and was registered in the Clinical Trials-gov (PROCENDIAS study). The CONSORT guidelines were rigorously followed in this randomized clinical trial. Information about the study, including the objectives, procedures, possible benefits and risks was provided at the beginning of the study and written informed consent, according to the general recommendations of the Declaration of Helsinki (World Medical, 2013), was obtained from each study participant.
Study Population:
The study was conducted in the municipality of Salamanca based on a list of people who attend an ADCC and whose relatives agree to participate voluntarily in the study. The reference population will be people attending ADCC and the relatives who participate in their care and who identify themselves as principal caregivers for this task.
Variables and measurement instruments The data will be collected in an interview, using the questionnaire designed for the study.
- Outcome variables:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in the study are those family members who help in the care of the person attending the ADCC at least two days a week;
- •Family caregivers perform or participate in organizing the dependent patient's preparation to visit the ADCC, with or without the help of another person. It is define "preparation for attendance" as all the activities performed by the caregivers in interaction with the patient, from the moment in which they begin to prepare until they get into the vehicle taking them to the ADCC, with the aim of facilitating their ADCC attendance. This includes, for example, waking them up, getting them out of bed, helping them shower and get dressed, assisting them at breakfast, helping them to walk and use the stairs, communicating with them about current actions and what they will be doing in the immediate future;
- •Family caregivers recognize the existence of at least one BPSD associated with ADCC care;
- •Signature of informed consent by family caregivers.
排除标准
- •Paid caregivers;
- •Family caregivers who do not participate in the preparation for the ADCC visit;
- •Those who do not sign informed consent.
结局指标
主要结局
disruptive behaviors
时间窗: Post intervention (6 months follow-up assessment will be performed)
Measured by the questionary disruptive behaviors will be measured with RMBPC
次要结局
未报告次要终点