Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Telomere length
研究概览
简要总结
The purpose of this study is to explore the differences in quality of life , inflammation, stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will complete the Stress-Busting Program for Family Caregivers in the language of their choice (English or Spanish).
详细描述
The overarching goal of this project is to (1) explore the differences in quality of life (QoL), inflammation, stress, telomere length, and mucosal immune function of Hispanic caregivers of persons with ADRD and (2) determine whether a caregiver intervention can effectively improve the QoL, inflammation, stress, telomere length, and mucosal immune function biomarkers of Hispanic caregivers.
The proposed study is a non-randomized trial design with three groups of ADRD caregivers that vary based on Hispanic ethnicity and English/Spanish language preference. The project's specific aims are:
Specific Aim 1: To compare the quality of life (QoL) (stress, depression, and burden), mucosal immunity function (sIgA), stress (sCortisol and sAmylase), inflammation(CRP), and telomere length in Spanish-speaking Hispanic, English-speaking Hispanic, and English-speaking non-Hispanic caregivers who participate in an evidence-based Stress-Busting Program (SBP) for family caregivers of family members living with ADRD. Working hypothesis: At baseline, Spanish-speaking Hispanic caregivers have lower QoL and immune function, higher levels of inflammation and stress, and shorter telomeres as compared to Hispanic and non-Hispanic English-speaking caregivers.
Specific Aim 2: To compare the impact of the SBP on QoL and biomarkers for stress, aging, inflammation and mucosal immunity among those caregivers completing the SBP (Hispanic caregivers completing the culturally adapted translated version to Spanish of SBP and Hispanic and non-Hispanic caregivers completing the English-SBP). Working Hypothesis: Spanish-speaking Hispanic caregivers completing the Spanish-SBP show more improvement in their QoL and biomarkers of stress, mucosal immunity, aging and inflammation post-intervention as compared to Hispanic and Non-Hispanic caregivers completing the English-SBP. To achieve these aims, the investigators propose to deliver the 9-week English SBP and the translated and culturally adapted Spanish-SBP. Saliva and blood samples and self- report measures of QoL will be collected at baseline and 9 weeks (end of intervention)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •self-identified caregiver for a person living with ADRD. Family caregivers of people with ADRD include spouses, adult children, grandchildren, siblings, partners, and significant others.
- •In addition to Alzheimer's disease, other causes of dementia include multiple sclerosis, Parkinson's, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI),
- •over the age of 18,
- •those wishing to participate in the Spanish SBP must speak and read Spanish.
排除标准
- •Speaking a language other than English or Spanish
- •Caring for an individual not diagnosed with a cognitive impairment as delineated in inclusion criteria.
研究组 & 干预措施
SBP ENGLISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
干预措施: SBP English (Behavioral)
SBP SPANISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish
干预措施: SBP SPANISH (Behavioral)
结局指标
主要结局
Telomere length
时间窗: Baseline and end of intervention (Week 9)
次要结局
- C Reactive Protein (CRP)(Baseline and end of intervention (Week 9))
- Saliva potential hydrogen (pH)(Baseline and end of intervention (Week 9))
- Salivary protein(Baseline and end of intervention (Week 9))
- Center for Epidemiologic Depression (CES-D)(Baseline and end of intervention (Week 9))
- Salivary flow rate(Baseline and end of intervention (Week 9))
- Perceived Stress Scale(Baseline and end of intervention (Week 9))
- Screen for Caregiver Burden(Baseline and end of intervention (Week 9))
- Salivary alpha Amylase (sAA)(Baseline and end of intervention (Week 9))
- Secretory immunoglobulin A (SIgA)(Baseline and end of intervention (Week 9))