Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Self-Care Inventory (SCI)
研究概览
简要总结
The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.
详细描述
Informal caregivers of persons with Frontotemporal degeneration (FTD) are an understudied population with unique needs. FTD is a common cause of young-onset dementia with no known cure. Behavioral variant FTD (bvFTD) is the most common of the FTD syndromes and involves a progressive disorder of emotional regulation and personality, and significant impairment in executive function. bvFTD caregivers face unique challenges which are particularly stressful, including young age at which the disorder appears, behavioral symptoms like apathy and disinhibition that are severe and appear early in bvFTD, and the lack of appropriate supportive services. Indeed, numerous studies have demonstrated that stress, depression and burden are higher in FTD caregivers than in any of the other ADRDs, yet caregiver interventions tested in specifically in the FTD population have been limited to a few small studies that focus on education around patient behavior management, not caregiver self-care.
The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.
30 caregivers will be randomized 1:1 to a health information: health information + health coaching group. Catered information will be delivered via tablets over 6 months with testing dispersed at baseline, 1 month, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, 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 Health Coaches providing the intervention and the caregiver participants will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informal caregiver providing care at least 8 hours/week
- •Reporting poor self-care on screening (Health Self-Care Neglect Scale, score ≥ 2)
- •Able to complete the protocol, e.g., adequate vision and hearing, English speaking
- •Caregiver of a patient diagnosed bvFTD
排除标准
- •Participation in another support randomized, controlled trial
- •Untreated major psychiatric illness (Use of anti-anxiety/anti-depressant medicines is acceptable and will be adjusted in analysis if group imbalance is identified.)
- •Caregiver with Cognitive Impairment based on Telephone Interview for Cognitive Status (TICS) score <25
结局指标
主要结局
Change From Baseline in the Self-Care Inventory (SCI)
时间窗: 6 months
30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
时间窗: 6 months
The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of "never" (0) to "all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior).
次要结局
- Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)(6 months)
- Change From Baseline in Perceived Stress Scale(6 months)
- Change From Baseline in Ways of Coping Questionnaire, Short Form(6 months)
- Change From Baseline in Zarit Burden Interview (ZBI)(6 months)
- Change From Baseline in Neuropsychiatric Inventory(6 months)