Caregiver Stress: Interventions to Promote Health and Wellbeing
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|ClinicalTrials.gov Identifier: NCT01188070|
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : February 23, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Health Promotion||Behavioral: Usual Care Behavioral: Psycho-education Behavioral: Psycho-education plus physical exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Caregiver Stress: Interventions to Promote Health and Wellbeing|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Sham Comparator: Usual Care Attention Control
Provision of printed educational material and attendance at one group session. This session will focus on nutrition education and flexibility and stretching.
Behavioral: Usual Care
Experimental: Psychoeducation plus exercise
Psychoeducation intervention plus an individualized exercise program which will include monitored, individually-prescribed aerobic and resistance exercise.
Behavioral: Psycho-education plus physical exercise
Psychoeducation intervention plus an individualized exercise program
Active Comparator: Psychoeducation
Psychoeducational program to involve group sessions over consecutive weeks. The sessions will use the principles of adult learning, emphasizing active learning, group exercises and discussion, and coaching as well as brief talks to provide content. The curriculum will focus on the strengthening of caregiver self-efficacy through enhancement of knowledge and understanding, the acquisition, strengthening, and practice of caregiving skills, and the development of a more clinical or strategic outlook on the caregiving role.
Educational group sessions
- Emotional outcomes [ Time Frame: Baseline and 6 months ]Depression, Anxiety, Caregiver Burden, Flourishing
- Behavioral Outcomes [ Time Frame: Baseline and 6 months ]Physical Activity, Sleep Quality
- Health Status [ Time Frame: Baseline and 6 months ]Function, Muscle strength, endurance
- Neuroendocrine [ Time Frame: Frame Baseline and 6 months ]Salivary Cortisol
- Cardiovascular Risk Outcomes [ Time Frame: Baseline and 6 months ]Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity & Risk
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188070
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Andrew Miller, MD||Emory University|
|Study Chair:||Kenneth Hepburn, PhD||Emory University|
|Study Chair:||Sandra Dunbar, DSN||Emory University|
|Study Chair:||Monica Parker, MD||Emory University|
|Principal Investigator:||Elizabeth J Corwin, PhD||Emory University School of Nursing|