Caregiver Stress: Interventions to Promote Health and Wellbeing

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
ECorwin, Emory University
ClinicalTrials.gov Identifier:
NCT01188070
First received: June 14, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Health Promotion
Behavioral: Usual Care
Behavioral: Psycho-education
Behavioral: Psycho-education plus physical exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Caregiver Stress: Interventions to Promote Health and Wellbeing

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Emotional outcomes [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Depression, Anxiety, Caregiver Burden, Flourishing

  • Behavioral Outcomes [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Physical Activity, Sleep Quality

  • Health Status [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Function, Muscle strength, endurance

  • Neuroendocrine [ Time Frame: Frame Baseline and 6 months ] [ Designated as safety issue: No ]
    Salivary Cortisol

  • Cardiovascular Risk Outcomes [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity & Risk


Enrollment: 354
Study Start Date: January 2010
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Educational materials
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.
Behavioral: Psycho-education
Educational group sessions

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188070

Locations
United States, Georgia
Emory Universtiy
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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
  More Information

No publications provided

Responsible Party: ECorwin, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01188070     History of Changes
Other Study ID Numbers: IRB000032005, P01NR011587
Study First Received: June 14, 2010
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Behavioral/Social
Cardiology
Clinical Laboratory Methods
Congestive Heart Failure
Heart Disease
Knowledge Dissemination
Lipids
Nursing
Health Promotion
Alzheimer's Disease/Dementia

ClinicalTrials.gov processed this record on October 23, 2014