Cardiovascular Risk Factor
Conditions
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.
Interventions
BEHAVIORALRICHH Intervention
Whole health cardiovascular disease (CVD) self-care risk reduction intervention
BEHAVIORALUsual care
Referral to primary care provider
Sponsors
National Institute of Nursing Research (NINR)
Debra Moser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
2 group randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lipid Profile Derived from point-of-care testing | Baseline, 4 and 12 months | lipid profile from point-of-care testing |
| Change in Body Mass Index (kg/m2) calculated from height and weight | Baseline, 4 and 12 months | body mass index calculated from height and weight |
| Change in Blood Pressure in mmHg | Baseline, 4 and 12 months | blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diet Quality measured by the Food Frequency Questionnaire | Baseline, 4 and 12 months | diet quality |
| Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study | Baseline, 4 and 12 months | adherence using Specific Adherence Scale from Medical Outcomes Study |
| Change in Depressive Symptoms | Baseline, 4 and 12 months | depressive symptoms measured using PHQ-9 |
| Change in Physical Activity Level (steps per 24 hours) measured by actigraphy | Baseline, 4 and 12 months | physical activity levels assessed using Withings actigraph |
Countries
United States
Outcome results
None listed