跳至主要内容
临床试验/NCT05582473
NCT05582473已完成不适用

Pilot Test of Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月7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
50
试验地点
1
主要终点
Change in Caregiver Self-Efficacy Scale

研究概览

简要总结

The overall goal of this study is to culturally adapt and test the effectiveness of Learning Skills Together (LST) in improving self-efficacy among Latino family caregivers. To address this overall goal, the study team propose the following aims: i) culturally adapt the LST intervention for Latino caregivers using a community-engaged approach; and ii) examine the effect of the LST intervention on Latino caregiver self-efficacy, depression, and well-being using a randomized wait-list control group.

详细描述

The study team will use a randomized wait-list control group design with blinded outcomes assessment to examine the effectiveness of LST-LC on caregiver confidence and self-efficacy in performing complex care tasks. This design has the advantage of making enrollment more feasible as participants may find the intervention highly desirable and will eventually receive it. Yet, the design provides a randomized comparison with a non-intervention control group. Participants will be individually randomized 1:1 to an immediate intervention group (IG) and a wait-list (delayed) control group (WLC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The research assistant will collect follow-up data and will be blinded to group assignment. Caregivers will be asked not to discuss whether they were in a group program prior to follow-up data collection with the research assistant. The statistician will also be blinded, with group assignment designated using a binary variable in anonymous study data. In order to conduct study activities, other team members will not be blinded.

入排标准

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

入选标准

  • •a family member to an individual living with AD/ADRD (Alzheimers Disease/Alzheimers Disease and related dementias) who has received a diagnosis from a physician,
  • •aged 18 years or older,
  • •providing assistance with at least two instrumental activities of daily living or one activity of daily living,
  • •providing care to a person with dementia in mid-stage as defined by a score between 4 and 6 on the Global Deterioration Scale (GDS), and
  • •not paid to provide care

排除标准

  • •are unable to read and speak English or Spanish,
  • •previously participated in LST, and/or
  • •have plans to place the care recipient in a skilled nursing facility within the next 6 months (i.e., study duration).
  • •Participants must have a Patient Health Questionnaire (PHQ-9) score of less than 15, the threshold for moderately severe depression
  • •Participants with severe depression

研究组 & 干预措施

Wait-List Control Group

No Intervention

Randomized subjects will wait for a 3 month period before being assigned to the LST-LC education. This group of subjects will act as the control group.

Learning Skills Together-Latino Caregivers (LST-LC)

Other

The study team convened a team of health care professionals, including nursing, occupational therapy, speech-language pathology, gerontology, nutrition, and dental hygiene, to develop a community-based education program for family caregivers.

干预措施: LST-LC Education (Behavioral)

结局指标

主要结局

Change in Caregiver Self-Efficacy Scale

时间窗: Baseline to 6 weeks

This is a unidimensional measure, with total score ranging between 1 and 10, with mean (SD) of 6.0 (2.1) in a sample of 158 caregivers (Ritter et al., 2022). Higher scores indicate higher confidence.

次要结局

  • Complex Care Tasks Scale(Baseline to 6 weeks)
  • Caregiver Confidence in Medical Sign/Symptom Management (CCSM) scale(Baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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