CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
研究概览
简要总结
Caregivers of home-dwelling people with Alzheimer's Disease and related dementias (ADRD) are one of the most rapidly growing populations in the United States. Among ADRD caregivers with unmet health-related social needs, this study aims to evaluate the effects of the CRx-D intervention versus usual care on caregiver self-efficacy.
详细描述
The CRx-D intervention is a caregiver-centered adaptation of CommunityRx (CRx), an information-based intervention that systematically matches people to nearby community resources for health-related social needs. We are conducting a single-blind randomized controlled trial and enrolling caregivers through UChicago-affiliated clinic sites. Caregivers will be screened and asked about unmet health-related social needs at the outpatient visit. Eligible, self-identified caregivers will complete an in-person baseline survey on-site (face to face), followed by phone surveys at 7, 30, 90 days, and 12 months. Caregivers randomized to the intervention will receive tailored information on community resources for their identified health-related social needs. They will also be given access to an online community-resource tool and shown how to use it, so they can search for additional resources in their community beyond the point-of-care and outside of the clinic. All caregivers (regardless of research arm) will also receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.
The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resides in the target geographic region of the study (living in 1 of the 35 target zip codes)
- •Self-identifies as a caregiver of a home-dwelling person with Alzheimer's Disease or related dementia using an adaptation of the BRFSS caregiver module
- •Has access to a cell phone and provides the research interviewer with the cell phone number
- •Agrees to receive text messages from the study
- •Has a personal email address.
- •Self-report their gender identity to be male or trans male/trans man (only for additional 50 caregivers enrolled in the 3-month RCT)
排除标准
- •Past enrollment in the CommunityRx-C study
- •Recollection of previous receipt of a HealtheRx
研究组 & 干预措施
Cases
Community Rx-Dementia "CRxD" Caregiver Resources
干预措施: Community Rx-Dementia "CRxD" Caregiver Resources (Behavioral)
Control
Usual Standard Care
结局指标
主要结局
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
时间窗: 12 months
Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = "strongly disagree" to 5 = "strongly agree" and will generate an average score. Higher values = greater self-efficacy
Satisfaction With Care
时间窗: 7 days
Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 \* (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction).
次要结局
未报告次要终点