Rural Intervention for Caregivers' Heart Health

Cardiovascular Risk Factor Clinical Trial

— RICHH  

Official title:

Rural Intervention for Caregivers' Heart Health (RICHH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068390
• Other study ID #: 1R01NR016824
• Secondary ID: 1R01NR016824
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Behavioral:
• RICHH Intervention
Whole health cardiovascular disease (CVD) self-care risk reduction intervention
• Usual care
Referral to primary care provider

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Debra Moser	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lipid Profile Derived from point-of-care testing	lipid profile from point-of-care testing	Baseline, 4 and 12 months
Primary	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
Primary	Change in Blood Pressure in mmHg	blood pressure	Baseline, 4 and 12 months
Secondary	Change in Diet Quality measured by the Food Frequency Questionnaire	diet quality	Baseline, 4 and 12 months
Secondary	Change in Depressive Symptoms	depressive symptoms measured using PHQ-9	Baseline, 4 and 12 months
Secondary	Change in Physical Activity Level (steps per 24 hours) measured by actigraphy	physical activity levels assessed using Withings actigraph	Baseline, 4 and 12 months
Secondary	Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study	adherence using Specific Adherence Scale from Medical Outcomes Study	Baseline, 4 and 12 months