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临床试验/NCT06963970
NCT06963970尚未招募不适用

Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2026年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
480
试验地点
2
主要终点
Zarit-12 Cargiver Burden Interview

研究概览

简要总结

The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.

详细描述

Aim 1: Determine CSNAV effectiveness in increasing rural Veterans' well-being, reducing rural care partner burden, and increasing rural care partner/Veteran satisfaction with VA care in the intervention group compared with the usual care Caregiver Support Program (CSP) group. The investigators will apply a 6-month intervention in a randomized control trial over 27 months. Primary Outcome: (H1) Care partners randomized to intervention group will have lower mean Zarit-1216 burden scores at 6 months compared to the control group. Secondary Outcomes: (H2) Care partners and Veterans randomized to the intervention group will have higher mean CAHPS Global Satisfaction17 scores at 6 months compared to the control group. (H3) Veterans randomized to the intervention group will have higher mean Warwick Edinburgh Mental Well-Being Scale18 scores at 6 months compared to the control group.

Aim 2: Following intervention, the investigators explore Veterans' and care partners' experience of CHWs as a mode of VA support using semi-structured interviews. The investigators then facilitate Delphi Method sessions with the Community Advisory Board plus study Veterans/care partners, CHWs, and key operational partners to examine Aims 1 & 2 data for intervention improvements and implementation planning using updated CFIR.19

Aim 3: Conduct budget impact analysis from the VA perspective to evaluate cost-drivers and assess feasibility to inform adaptation and implementation of the intervention within a VA regional network.

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
Single (Outcomes Assessor)

盲法说明

Study staff collecting baseline and 6 month measures will be masked to the arm enrollment of participants.

入排标准

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

入选标准

  • Care Partner Inclusion Criteria
  • A relative, friend, or partner (18 years of age) with whom Veteran patient has a personal relationship who assists Veteran regularly with care and/or care coordination as defined under "Veterans" below
  • Residing in a rural area based on RUCC or Rural-Urban Continuum Codes 83
  • Must be enrolled in Caregiver Support Program (CSP) Program of General Caregiver Support Services
  • Can live with or separately from the Veteran; able to communicate in English by phone
  • Veteran Inclusion Criteria
  • Receiving care at Durham, Asheville, and Richmond VA Health Systems (e.g., at least 2 outpatient visits in past year; has a primary provider) and residing in a rural area.
  • Diagnosed with congestive heart failure, chronic obstructive pulmonary disease, cancer, dementia, or end-stage renal disease.
  • Requires assistance with at least one Activities of daily living (ADLs) (i.e., walking, feeding, toileting, transferring, bathing, or dressing) or Instrumental activities of daily living (IADL) (i.e., transport, medication, financial management, shopping, or meal preparation)
  • 50 years old or older and able to communicate in English by phone (for assessments)

排除标准

  • Veteran Exclusion Criteria
  • Flag or social work note indicating suspected Caregiver abuse
  • Unable to communicate in English by phone for assessments

研究组 & 干预措施

Community Health Worker support

Experimental

Additional weekly remote support of care partner using a trained/certified community health worker

干预措施: Remote Community Health Worker support (Other)

Regular support

No Intervention

Regular care

结局指标

主要结局

Zarit-12 Cargiver Burden Interview

时间窗: baseline and 6 months

Care partners randomized to intervention will have lower mean Zarit-12 scores at 6 months compared to the control group. Each question is scored on a five-point Likert scale from 0 to 4, with higher scores representing a greater feeling of burden. The total ZBI-12 score is the summation of 12 items, with a total score range from 0 to 484. Higher indicates more burden. A cut-off score of 13 points on the ZBI-12 is suggested for screening burden in community-dwelling older caregivers, but should not be assumed as normative data. 5 categories: health, psychological well-being, finances, social life, relationship with impaired person. 12 item, α=0.88-0.91

次要结局

  • 1-item CAHPS Global Satisfaction Measure(baseline and 6 months)
  • Warwick Edinburgh Mental Well-Being Scale(baseline and 6 months)
  • Connection Measure(baseline and 6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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