Clinical trial NCT03068390: Rural Intervention for Caregivers' Heart Health
Official title: Rural Intervention for Caregivers' Heart Health (RICHH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-03-01
Enrollment: 311
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group randomized controlled trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Lipid Profile Derived from point-of-care testing
timeFrame: Baseline, 4 and 12 months
measure: Change in Body Mass Index (kg/m2) calculated from height and weight
timeFrame: Baseline, 4 and 12 months
measure: Change in Blood Pressure in mmHg
timeFrame: Baseline, 4 and 12 months
Secondary outcomes:
measure: Change in Diet Quality measured by the Food Frequency Questionnaire
timeFrame: Baseline, 4 and 12 months
measure: Change in Depressive Symptoms
timeFrame: Baseline, 4 and 12 months
measure: Change in Physical Activity Level (steps per 24 hours) measured by actigraphy
timeFrame: Baseline, 4 and 12 months
measure: Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study
timeFrame: Baseline, 4 and 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Debra K Moser, PhD
role: PRINCIPAL_INVESTIGATOR
References: