Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months
研究概览
简要总结
SHARE-CC is an intervention for families facing the challenges of chronic conditions. SHARE-CC (Support, Help, Activities, Resources, and Education) addresses the need for both members of a care dyad to be actively involved in current and future care planning. This intervention aims to increase knowledge of services, improve communication skills and well-being, and facilitate the understanding of care values and preferences in order to create a mutually agreed upon care plan. This intervention will be tested in a randomized control trial.
详细描述
This project offers a unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of the SHARE-Chronic Conditions psycho-social intervention. The project will adapt the SHARE intervention, for use with dyads facing the challenges of chronic conditions. The six-session SHARE-CC program will be implemented and evaluated using a randomized controlled trial with 240 participants in northern Ohio, the San Diego and San Francisco Bay areas in California, and New Jersey.
The SHARE-CC intervention addresses the need for a structured approach that targets both members of a care dyad and empowers them to be actively involved in current and future care planning. It has great potential to not only improve psychosocial outcomes for families, but to also impact healthcare decision-making and utilization.
Persons with chronic conditions and their caregivers will be interviewed prior to (Time 1) and after participating (approximately 4 months post-Time 1) in the SHARE-CC intervention or PWCC control group.
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 (Participant)
盲法说明
No other parties will be masked in the trial
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
- •Living in geographic area of organizations delivering service
- •Living at home rather than in an institutional setting
- •Have a family CG as defined below
- •Confirmed diagnosis of at least one chronic illness (e.g., heart disease, diabetes, COPD, arthritis, kidney disease, stroke, HIV-AIDS, etc.)
- •Require assistance with two or more activities of daily living (e.g., shopping, managing medications, dressing) or receives help with complex medical care tasks (e.g., wound care, preparing special meals); and
- •Short Blessed error score between 0 and 6 demonstrating normal cognitive function.
- •For CGs to be eligible
- •must be the PWCC's spouse/partner, adult child, in-law, grandchild, step-child, or other close family member who has or will have primary responsibility for providing assistance to the PWCC
排除标准
- •Out of geographic areas
- •a primary diagnosis of a neurocognitive disorder (e.g. Alzheimer's Disease or related dementia)
- •a mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
- •a traumatic brain injury,
- •intellectual or developmental disability
- •individuals experiencing extreme difficulty adjusting and coping to the diagnosis
- •individuals in the terminal phase of a chronic condition (i.e., eligible for Hospice).
研究组 & 干预措施
SHARE for Chronic Conditions
Six weekly "SHARE for Chronic Conditions (SHARE-CC)" sessions will be conducted in the dyad's home or another location preferred by the participants. A care plan (the SHARE plan) is created that reflects the mutual decisions made by the dyad as a result of their participation in the SHARE-CC program. The SHARE plan is intended to help the caregiver (CG) ensure the PWCC's values and preferences are supported when decisions have to be made in an emergency or in the end stages of the disease. SHARE plans will be documented in a notebook that also contains information on key topics and provides links to local and online resources and services.
干预措施: SHARE-CC (Behavioral)
Health Coaching
Six 30-minute weekly telephone calls to provide information and education related to the PWCC's conditions and information about services and care options will be conducted.
结局指标
主要结局
Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months
时间窗: Measured at baseline and 4 months later
To measures affect, we will use the Positive Affect (6 items) and Negative Affect (9 items) scales of the Dementia Quality of Life Instrument (DQoL; Brod et al., 1999), modified to include only the positive and negative affect subscales in order to reduce response burden
Change from Baseline Service Availability Measure (SAM) at 4 months
时间窗: Measured at baseline and 4 months later
Asks caregiver if they or their care partner have used any of the 14 services listed (i.e., counseling, support group, respite). If a caregiver has not used a service then their knowledge of the availability of that service is measured
Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months
时间窗: Measured at baseline and 4 months later
Assesses the extent to which a person engaged in eight behaviors during the past month related to withholding or distorting information about their symptoms and feelings to protect their partner from worrying (i.e., how often have you acted more cheerful than you feel?).
次要结局
- Change from Baseline Dyadic Relationship Scale at 4 months(Measured at baseline and 4 months later)
- Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months(Measured at baseline and 4 months later)
- Change from Baseline Disagreements Scale at 4 months(Measured at baseline and 4 months later)
- Change from Baseline Health Care Utilization at 4 months(Measured at baseline and 4 months later)