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临床试验/NCT01188070
NCT01188070已完成不适用

Caregiver Stress: Interventions to Promote Health and Wellbeing

Emory University2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
354
试验地点
2
主要终点
Cardiovascular Risk Outcomes

研究概览

简要总结

More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Identification of effective self-care interventions for family caregivers is warranted to improve their emotional wellbeing and minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with chronic illness. In two studies the investigators will test two interventions, psycho-education(ED) and physical exercise(EX), individually and in combination. The first study will target FCG of African American dementia patients; the second will focus on FCG of heart failure patients. Parallel designs, interventions and measures will create synergy as will integration of all data management and analyses within a Bio-behavioral Science and Measures Core. This Core will also provide high level guidance and interpretation of model testing resulting from analysis of the common data set. The combined de-identified data set will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk, further developing the model, and stimulating future research, while the shared core support will provide substantial efficiency; neither could be achieved outside of a Program Project approach. These collective efforts will generate important data whereby future care can significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the number one cause of disability and death in the United States.

We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater physical function), cardiovascular risk measures (improved resting heart rate, blood pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved function, muscle strength, and endurance) compared to psycho-education and usual care-attention control from baseline to six months later mediated by improvements in process outcomes (lower perceived stress and higher self-efficacy).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Family caregiver defined as a spouse, partner or other adult family member living in the same house or in contact with a HF patient or dementia patient in a caregiver relationship at least 4 times/week for at least one hour or more.
  • willing to participate
  • English fluency
  • ambulatory and physically able to engage in a structured low impact walking and upper body strength training program.
  • self identify as African American for the Alzheimer FCG study

排除标准

  • non sedentary (defined as engaging in > 30 minutes of moderately strenuous exercise 3 times or more a week)
  • medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal insufficiency, or a history of angina with activity)
  • current psychiatric comorbidity (alcohol or drug abuse/dependence, bipolar or psychotic disorder, suicidal ideation detected on the MINI screening tool)
  • current smoker
  • cognitive problems (BLESSED screen)
  • ischemic changes or inappropriate BP changes on BL exercise (modified Balke) treadmill test
  • on corticosteroids
  • experiencing an acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply)

结局指标

主要结局

Cardiovascular Risk Outcomes

时间窗: Baseline and 6 months

Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity \& Risk

Health Status

时间窗: Baseline and 6 months

Function, Muscle strength, endurance

Behavioral Outcomes

时间窗: Baseline and 6 months

Physical Activity, Sleep Quality

Neuroendocrine

时间窗: Frame Baseline and 6 months

Salivary Cortisol

Emotional outcomes

时间窗: Baseline and 6 months

Depression, Anxiety, Caregiver Burden, Flourishing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ECorwin

Professor

Emory University

研究点 (2)

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