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Completed

NCT Number: NCT03068390

Rural Intervention for Caregivers' Heart Health

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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40535, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RICHH Intervention

Behavioral

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

Usual Care

Behavioral

Referral to primary care provider

Primary outcomes

  1. Change in Lipid Profile Derived from point-of-care testing

    Time frame: Baseline, 4 and 12 months

    lipid profile from point-of-care testing

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

    Time frame: Baseline, 4 and 12 months

    body mass index calculated from height and weight

  3. Change in Blood Pressure in mmHg

    Time frame: Baseline, 4 and 12 months

    blood pressure

Secondary outcomes

  1. Change in Diet Quality measured by the Food Frequency Questionnaire

    Time frame: Baseline, 4 and 12 months

    diet quality

  2. Change in Depressive Symptoms

    Time frame: Baseline, 4 and 12 months

    depressive symptoms measured using PHQ-9

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

    Time frame: Baseline, 4 and 12 months

    physical activity levels assessed using Withings actigraph

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

    Time frame: Baseline, 4 and 12 months

    adherence using Specific Adherence Scale from Medical Outcomes Study

Sponsors and collaborators

Lead sponsor

Debra Moser

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Rural Intervention for Caregivers' Heart Health (RICHH)

Acronym: RICHH

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2017
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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