Impact of the HELPeN Telecare Program on Social Isolation and Loneliness in Community-dwelling Elders: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Loneliness
研究概览
简要总结
The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs).
Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months.
Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score <32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group.
The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank.
The control group will not receive any intervention.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Data will be collected by three team members who will make a telephone call to the study participants and record the study variables on four occasions throughout the study. They will be blinded, i.e., they will have no information about the major. Also, the data analyst will not know to which group each subject belongs.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •score < 32 (Low perceived social support with the DUFSS scale)
- •Residence in the community
排除标准
- •Severe cognitive impairment (8-10 errors on the Pfeiffer test)
- •Non Spanish speakers
- •Failure to consent to the study
结局指标
主要结局
Loneliness
时间窗: 9 months
Name of the measurement: Loneliness Definition: Loneliness is the result of a cognitive evaluation where there are discrepancies between the social relationships that people desire and those that they really have. Measuremente tool: UCLA Loniness Scale. Developed by psychologist Daniel Russell (1996), the UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Unit of measure: Indicence of loneliness
Social isolation
时间窗: 9 months
Name of the measurement: Social isolation Definition: Disengagement from social relationships, connections with institutions or community involvement. Measurement tool: DUKE-UNC Functional Social Support questionnaire(DUFSS). A 14-item, self-administered, multidimensional, functional social support questionnaire. Unit of measure: Incidence of social isolation
次要结局
- Phisycal function(9 months)
- Depression(9 months)
- Anxiety(9 months)
- Drugs(9 months)
- Mental status(9 months)
- Health Related Quality of life(9 months)
- Health assistance(9 months)
研究者
MARIA RUZAFA MARTINEZ
Associate Professor. Faculty of Nursing. University of Murcia
Universidad de Murcia