跳至主要内容
临床试验/NCT04131790
NCT04131790已完成不适用

Improving Social Connectedness in Home Delivered Meals Clients

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2017年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale

研究概览

简要总结

The purpose of this study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •English speaking
  • •Clients of the Meals on Weals program
  • •≥60 years old
  • •Score between 6-9 on the Hughes three-item version of the UCLA Loneliness Scale

排除标准

  • •Dementia, as indicated by a score > 3 on the Six Item Screen
  • •Clinically significant depression, as indicated by a score ≥15 on the Patient Health Questionnaire (PHQ-9)
  • •Active suicide risk, as indicated by a positive response on any item of the Columbia Suicide Severity Rating Scale (C-SSRS)
  • •Uncorrectable hearing or vision impairment

研究组 & 干预措施

Tele-Behavioral Activation

Experimental

Manualized Behavioral Activation (BA) protocol delivered via videoconferencing by a trained BA interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist guides participants in learning BA skills, focusing on strategies to decrease barriers to social connectedness (e.g., limited mobility, inadequate caregiving resources).

干预措施: Tele-Behavioral Activation (Behavioral)

Tele-Friendly Visiting

Active Comparator

Friendly Visitor (FV) calls delivered via videoconferencing by a trained FV interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist provides social support to participants through good listening and provision of genuine regard.

干预措施: Tele-Friendly Visiting (Behavioral)

结局指标

主要结局

Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale

时间窗: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).

An 8-item self-report questionnaire used to measure perceived social isolation using a Likert scale (5-point scale: 'never' = 1 to 'always' = 5). Total raw scores range from 8-40; raw scores are converted to T-scores using an appendix (T-scores are standardized scores that have a mean of 50 and SD of 10). Higher T-score values represent greater perceived social isolation.

Change over time in social support measured using the Duke Social Support Index (DSSI)

时间窗: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).

A 10-item self-report questionnaire used to measure an individual's satisfaction with social support using a Likert scale (3-point scale, where anchor labels are specified for each item). This scale consists of two subscales: 4-item social interaction (objective support) scale and 6-item satisfaction with social support (subjective support) subscale. Total scores are calculated by summing responses to items across all items; total scores range 10-30.

次要结局

  • Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)(Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).)
  • Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)(Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha L. Bruce

Professor

Dartmouth-Hitchcock Medical Center

研究点 (1)

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