Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of Participants Recruited Within the Goal of 12 Months
研究概览
简要总结
The purpose of this study is to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. The study aims to enroll 30 dyads of people with moderate and severe dementia and their family caregivers.
详细描述
African Americans (AAs) are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease and related dementias (ADRD) and will account for 20% of persons living with dementia (PLWD) by 2050. PLWD experience progressive distress and confusion, which decreases their quality of life and also contributes to the emotional strain, burden, social isolation, and depression experienced by caregivers. Research indicates that religiosity (the inner commitment to one's faith through integration of religious beliefs and practices into one's life) can serve as a protective factor against the stressors associated with caregiving and living with ADRD.
The goal of this clinical feasibility trial and NIH stage 1 intervention development project is to go beyond the four walls of the church to find ways to meet the spiritual needs of persons living with moderate and severe ADRD "where they are" in order to help them remain religiously and spiritually engaged. This study is premised on the notion that religious/spiritual engagement is possible and beneficial for PLWD and that this beneficial effect will extend to their caregivers.
The purpose of this project is to design and test the feasibility of employing components of a Faith-based Home Activity Toolbox (Faith-HAT) and create intervention tools for a full-scale randomized controlled trial (RCT) to test the efficacy-effectiveness of faith-based programs on patient and caregiver outcomes.
Thirty dyads of people with dementia and their caregivers will be enrolled in a 6 week program to test the feasibility and preliminary effectiveness of using Faith-HAT. A final study follow-up assessment occurs 6 weeks after the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •at least 18 years of age
- •reside with and care for (average of 4 hours/per day of unpaid assistance) for a family or friend experiencing signs and symptoms of moderate or severe ADRD as indicated through self-report or family caregiver report
- •able to read, speak, and understand English
- •cognitively intact
- •access to a wireless internet connection (wi-fi)
- •access to a phone or mobile device that accepts text messages
- •PLWD Inclusion Criteria:
- •community-dwelling experiencing signs and symptoms of moderate or severe ADRD through self-report or family caregiver report
- •has a family caregiver that resides with them and is willing to participate
- •no plan for institutionalization in the next month
- •history of participating in private or public religious activities
- •understands English (toolbox activities will be produced in English)
- •family and self-reporting of the level of cognitive impairment identified according to the signs and symptoms of moderate and severe ADRD associated with the Alzheimer's Association16 categorization of moderate/middle, and severe/late stages of dementia
排除标准
- •does not have a history of participating in private or public religious activities
- •hostile to PLWD religious expression
- •has active plans to move to another residence without family member with ADRD
- •PLWD Exclusion Criteria:
- •has active plans to move from under care of primary caregiver
- •routinely attends church
- •hostile to religion
- •unwilling to engage in Faith-HAT
结局指标
主要结局
Number of Participants Recruited Within the Goal of 12 Months
时间窗: At enrollment (up to 21 months of study)
Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
Number of Participants Engaging in the Intervention at Least Two Days Per Week
时间窗: Week 6
Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention.
Number of Dyads Completing the Study
时间窗: Month 20 of the study
The feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study.
Zarit Burden Inventory Score
时间窗: Baseline, Week 6
The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden.
Perceived Stress Scale Score
时间窗: Baseline, Week 6
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
时间窗: Baseline, Week 6
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression.
Revised Memory and Behavior Problem Checklist Score
时间窗: Baseline, Week 6
The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors.
Medical Outcomes Study Sleep Scale (MOS-Sleep) Score
时间窗: Baseline, Week 6
The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index).
次要结局
- Caregiver Heart Rate Variability Time Domain(Baseline, Week 6)
- Caregiver Heart Rate Variability Frequency Domain(Baseline, Week 6)
- Caregiver Skin Conductance Level (SCL)(Baseline, Week 6)
研究者
Fayron Epps
Adjunct Associate Professor
Emory University