Caregiver Stress: Interventions to Promote Health and Wellbeing

NCT01188070 | Completed DMC

• 2 other identifiers: IRB00032005P01NR011587
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Health Promotion

Keywords

Behavioral/Social; Cardiology; Clinical Laboratory Methods; Congestive Heart Failure; Heart Disease; Knowledge Dissemination; Lipids; Nursing; Health Promotion; Alzheimer's Disease/Dementia

Outcome Measures

Primary Outcomes (5)

• Emotional outcomes

  Depression, Anxiety, Caregiver Burden, Flourishing

  Baseline and 6 months

• Behavioral Outcomes

  Physical Activity, Sleep Quality

  Baseline and 6 months

• Health Status

  Function, Muscle strength, endurance

  Baseline and 6 months

• Neuroendocrine

  Salivary Cortisol

  Frame Baseline and 6 months

• Cardiovascular Risk Outcomes

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

  Baseline and 6 months

Study Arms (3)

Usual Care Attention Control

SHAM COMPARATOR

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

Psychoeducation plus exercise

EXPERIMENTAL

Psychoeducation intervention plus an individualized exercise program which will include monitored, individually-prescribed aerobic and resistance exercise.

Behavioral: Psycho-education plus physical exercise

Psychoeducation

ACTIVE COMPARATOR

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

Interventions

Usual Care BEHAVIORAL

Educational materials

Usual Care Attention Control

Psycho-education BEHAVIORAL

Educational group sessions

Psychoeducation

Psycho-education plus physical exercise BEHAVIORAL

Psychoeducation intervention plus an individualized exercise program

Psychoeducation plus exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Emory Universtiy

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Corrigendum. J Appl Gerontol. 2020 Feb;39(2):NP1. doi: 10.1177/0733464818775576. Epub 2018 Apr 30.

  PMID: 29708007 DERIVED

• Gary R, Dunbar SB, Higgins M, Butts B, Corwin E, Hepburn K, Butler J, Miller AH. An Intervention to Improve Physical Function and Caregiver Perceptions in Family Caregivers of Persons With Heart Failure. J Appl Gerontol. 2020 Feb;39(2):181-191. doi: 10.1177/0733464817746757. Epub 2018 Jan 18.

  PMID: 29347863 DERIVED

MeSH Terms

Conditions

Behavior; Heart Failure; Heart Diseases; Alzheimer Disease; Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrew Miller, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Kenneth Hepburn, PhD

  Emory University

  STUDY CHAIR

• Sandra Dunbar, DSN

  Emory University

  STUDY CHAIR

• Monica Parker, MD

  Emory University

  STUDY CHAIR

• Elizabeth J Corwin, PhD

  Emory University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: August 25, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)