Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (iCare4Me Homecare)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Short Form Health Survey (SF-36) (Both)
研究概览
简要总结
This RCT design will enroll 256 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months.
详细描述
Purpose and Specific Aims
Cognitive Impairment (CI) has been reported to be as high as 78% in older adults with Heart Failure (HF). CI markedly increases the risk of adverse HF outcomes such as hospitalization and death, and patients with CI and HF are rarely able to manage without a caregiver. The high level of caregiving demands lead to an increase in stress and strained relationships with caregiving recipients, which can lead to poor coping and decreased mental health among caregivers. This study aims to test a self-care intervention (Virtual Caregiver Coach for You -ViCCY) targeting caregivers to support mental health and explore whether changes in caregiver mental health impacts patient outcomes. We will examine relationship strain as the primary mechanism for improvements in outcomes in patients and caregivers.
Aim 1: Test the efficacy of ViCCY vs. UC in improving outcomes of caregivers of home health care (HHC) patients with HF/CI.
Aim 2: Explore the effect of ViCCY on outcomes in HHC patients with HF/CI. At 6-months we will report differences in mental health measured with the SF-36 and its contributors of depression, anxiety, and somatic HF symptoms between patients whose caregivers are randomized to ViCCY compared to UC.
Aim 3: Describe the mechanisms by which outcomes are achieved.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The coach providing the intervention, Dr. Hirschman (fidelity), and the caregiver participants will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria
- •Older adults (=>50 years of age)
- •Enrolled in Home Health Care
- •Documented to have HF
- •Mild to moderate CI on the BIMS or OASIS items
- •Able to provide informed consent
- •Able to provide self-report data
- •Caregiver Inclusion Criteria
- •Adults (=>18 years of age)
- •Spouse/partner/child or other informal caregiver living with or in close proximity to the patient
- •Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment
- •Reporting poor self-care on screening (Health Self-Care Neglect scale score =>2)
- •Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score <12)
- •Caregiving or supporting the patient at least 8 hours/week
- •Able to complete the protocol, e.g., adequate vision and hearing, English speaking.
- •Able to provide informed consent
- •Able to use technology
排除标准
- •Patient Exclusion Criteria
- •Dementia (ICD-10 code for dementia)
- •Enrolled in hospice
- •Non-English speaking
- •Caregiver Exclusion Criteria
- •Non-English speaking
研究组 & 干预措施
ViCCY Intervention
The intervention group will receive 10 sessions of ViCCY over 6-months.
干预措施: ViCCY (Behavioral)
Usual Care
Usual Home Health Care.
结局指标
主要结局
Short Form Health Survey (SF-36) (Both)
时间窗: Baseline, 3- and 6- and 12-months
Mental health is a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well. The SF-36 provides standardized scores and national norms for comparison. The SF-36 is valid in many populations and caregivers. It is one of the common data elements.
次要结局
- Self-Care of Informal Caregiver Inventory (Caregiver)(Baseline, 3- and 6- and 12-months)
- Perceived Stress Scale short form (Caregiver)(Baseline, 3- and 6- and 12-months)
- Brief-COPE (Caregiver)(Baseline, 3- and 6- and 12-months)
- Dyadic Relationship Scale (Both)(Baseline, 3- and 6- and 12-months)
- HF Caregiver Questionnaire (Patient)(Baseline, 3- and 6- and 12-months)
- Patient Health Questionnaire (PHQ-9) (Patient)(Baseline and 6-months)
- Generalized Anxiety Disorder (GAD-7) (Patient)(Baseline and 6-months)
- HF Somatic Perception Scale (Patient)(Baseline and 6-months)
- Charlson Comorbidity Index (Patient)(Baseline and 6-months.)