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Purpose

The investigators are testing a two-group, randomized, controlled trial with 280 primary caregivers of adult patients with a chronic illness to test the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors, and depressive symptoms will be compared to usual care. The investigators also will test the moderating effect of gender on intervention outcomes, given the many differences between male and female caregivers. Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months. Hypotheses 1: The intervention group will have better lipid profile, body mass index, and blood pressure outcomes than the usual care group at 4 and 12 months. Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors (i.e., diet quality, physical activity level, and self-report adherence to specific CVD health behaviors). Hypotheses 2: The intervention group will have better diet quality, higher physical activity levels, and better adherence to specific CVD health behaviors than the usual care group at 4 and 12 months. Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months. Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive symptoms than caregivers receiving usual care at 4 and 12 months. Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by caregivers' gender. Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12 months. Impact: The proposed study will have a substantial impact on caregivers' cardiovascular health and quality of life because it will provide needed CVD risk prevention, and health promotion to rural caregivers living in distressed environments where CVD risk reduction and self-management is difficult. The intervention holds the potential to produce major improvements in health among caregivers living in rural environments in the US.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • primary family rural caregiver of patients with chronic illnesses
  • provided care for the patient for > 6 months
  • no cognitive impairment that would preclude understanding the consent process

Exclusion Criteria

  • chronic drug abuse
  • current active cancer
  • any physical or emotional impairment that limits participants' abilities to engage in self-management or that is likely to result in needing a caregiver in the next 12 months.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
2 group randomized controlled trial
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RICHH Intervention
The RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads that we provide for all participants. Participants keep the mini-iPads at the end of the study. The program consists of 12 weekly sessions [30-45 minutes] followed by 8 bi-weekly [every other week] booster sessions and 6 monthly booster sessions that will be held at the caregivers' preferred times using a video conferencing program. A cardiac psychiatric advanced practice nurse certified cognitive behavioral therapy will deliver the intervention.
  • Behavioral: RICHH Intervention
    Whole health cardiovascular disease (CVD) self-care risk reduction intervention
Active Comparator
Usual care
The usual care control group will receive an attention placebo intervention in which the caregivers will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified.
  • Behavioral: Usual care
    Referral to primary care provider

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40535
Contact:
Debra K Moser, PhD, RN
859-323-6687
dmoser@uky.edu

More Details

NCT ID
NCT03068390
Status
Recruiting
Sponsor
Debra Moser

Study Contact

Debra K Moser, PhD
859-323-6687
dmoser@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.