Rural Intervention for Caregivers' Heart Health

NCT03068390 | Completed

• 1 other identifier: 1R01NR016824
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (3)

• Change in Lipid Profile Derived from point-of-care testing

  lipid profile from point-of-care testing

  Baseline, 4 and 12 months

• Change in Body Mass Index (kg/m2) calculated from height and weight

  body mass index calculated from height and weight

  Baseline, 4 and 12 months

• Change in Blood Pressure in mmHg

  blood pressure

  Baseline, 4 and 12 months

Secondary Outcomes (4)

• Change in Diet Quality measured by the Food Frequency Questionnaire

  Baseline, 4 and 12 months

• Change in Depressive Symptoms

  Baseline, 4 and 12 months

• Change in Physical Activity Level (steps per 24 hours) measured by actigraphy

  Baseline, 4 and 12 months

• Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study

  Baseline, 4 and 12 months

Study Arms (2)

RICHH Intervention

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

RICHH Intervention BEHAVIORAL

Whole health cardiovascular disease (CVD) self-care risk reduction intervention

RICHH Intervention

Usual care BEHAVIORAL

Referral to primary care provider

Usual care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debra Moser: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40535, United States

Location

Study Officials

• Debra K Moser, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Model Details: 2 group randomized controlled trial

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: March 1, 2017
• Study Start: February 24, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)