跳至主要内容
临床试验/NCT06860035
NCT06860035招募中不适用

Dementia Caregivers' Link to Assistance and Resources: Supporting Caregivers of Home Health Patients With Dementia

Visiting Nurse Service of New York1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Completion rate for DECLARE caregiver assessments

研究概览

简要总结

The goal of this clinical trial is to learn if the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program can improve support of, and engagement with, caregivers of home health patients with dementia. DECLARE includes a caregiver self-assessment that is reported in the home health patient record, and increased access to social work for cases including dementia caregivers. The main questions we aim to answer are:

  • Will most caregivers who are offered the chance to complete an assessment choose to do so?
  • Will clinicians report that the assessment information was useful?
  • Will the rate of social work access increase for cases with patients with dementia who have involved family caregivers?

Researchers will compare DECLARE to usual care to see if taking part in the program increases caregiver self-efficacy and access to social work.

Participants will:

  • Answer a short series of assessment questions and questions about their caregiving experiences at the beginning of the home health episode.
  • Receive a social work visit from a Licensed Social Worker trained in dementia care.
  • Answer a series of follow-up questions about their caregiving experiences at the end of the home health episode.

详细描述

The goal of the present study is to pilot test a novel ADRD caregiver assessment instrument, designed specifically for the HH setting, with the ultimate aims of improving caregiver self-efficacy and increasing access to social work during HH for cases involving caregivers who are experiencing high strain and/or low preparedness for caregiving. This is the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program. Specific Aims include: (1) Contacting eligible caregivers to field a caregiver self-assessment and sharing caregiver responses with frontline staff in the patient record, (2) Identifying cases for social work access, and (3) Assessing the feasibility, acceptability, and impact on caregiver outcomes of the activities described in Aims 1 and 2.

This is an embedded Pragmatic Clinical Trial (ePCT) within the VNS Health home health agency. We will implement the intervention in 4 "treatment" branches (includes 8 clinical teams) and will compare to 6 "control" branches (includes 12 clinical teams). Treatment branches will receive the DECLARE intervention described in the following section and control branches will not have any intervention. In both arms, we will conduct baseline and follow-up telephone surveys with caregivers of eligible cases to gather outcomes data. We anticipate a 12-month trial, with regular analytic checkpoints to assess for potential issues and make revisions as needed.

We will identify eligible cases based on the start of care OASIS (home health patients 65 and older with diagnosed ADRD, a caregiver on record with a phone number, and payment through Traditional Medicare or a Medicare Advantage plan managed by VNS Health. Research staff will contact the caregiver of record via telephone to field the self-assessment survey. In treatment branches, caregiver responses will be entered into a secure survey platform (RedCAP) and uploaded to the patient electronic health record (HomeCare HomeBase) as a care coordination note. For cases without a social work order, the research team will either (a) contact the Clinical Field Manager to request a social work order, if none exists or (b) contact the appropriate social worker if a social work order is already in place. We anticipate 150 participants (60 from treatment branches and 90 from control branches).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Individual must be listed as the caregiver of record for a patient receiving home health care from the partner home health agency and have a phone number on file; the patient must meet the inclusion criteria listed below.
  • Home health patient (care recipient) must have a documented dementia diagnosis on the home health assessment, be 65 years or older, and have Traditional Medicare or Medicare Advantage as their primary payer for the home health episode.

排除标准

  • Caregivers are excluded if they are unable to communicate in English.

研究组 & 干预措施

Treatment (DECLARE)

Experimental

The intervention for treatment branches includes two parallel processes: (1) calling eligible caregivers to field a self-assessment instrument and upload caregiver responses to the patient record, and (2) identifying and flagging cases for expedited social work access with dementia-trained social workers. Participants will also be contacted for a follow-up survey (at the end of home health care) to capture outcomes data.

干预措施: Dementia Caregivers' Link to Assistance and Resources (DECLARE) (Other)

Comparison (Usual care)

No Intervention

The comparison arm will receive usual care. Eligible caregivers will be contacted via telephone to field baseline and follow-up surveys to capture outcomes data for comparison.

结局指标

主要结局

Completion rate for DECLARE caregiver assessments

时间窗: 7 days

A proportion. Numerator: the number of eligible caregivers who complete the DECLARE assessment. Denominator: the number of eligible caregivers who are contacted and asked to complete the DECLARE assessment at the start of the episode.

Caregiver Self-Efficacy

时间窗: 60 days

Caregiver self-efficacy, as measured by caregiver score on the Caregiver Self-Efficacy (CSE-4) 4-item scale developed by Merrilees, et al (2020).

次要结局

  • Acceptability among Clinicians(12 months)
  • Access to Social Work(12 months)
  • Acceptability among Caregivers(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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