Rural Intervention for Caregivers' Heart Health (RICHH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03068390|
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : August 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factor||Behavioral: RICHH Intervention Behavioral: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 group randomized controlled trial|
|Official Title:||Rural Intervention for Caregivers' Heart Health (RICHH)|
|Actual Study Start Date :||February 24, 2017|
|Estimated Primary Completion Date :||August 21, 2021|
|Estimated Study Completion Date :||August 21, 2021|
Experimental: RICHH Intervention
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
Whole health cardiovascular disease (CVD) self-care risk reduction intervention
Active Comparator: Usual care
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
Referral to primary care provider
- Change in Lipid Profile Derived from point-of-care testing [ Time Frame: Baseline, 4 and 12 months ]lipid profile from point-of-care testing
- 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
- Change in Blood Pressure in mmHg [ Time Frame: Baseline, 4 and 12 months ]blood pressure
- Change in Diet Quality measured by the Food Frequency Questionnaire [ Time Frame: Baseline, 4 and 12 months ]diet quality
- Change in Depressive Symptoms [ Time Frame: Baseline, 4 and 12 months ]depressive symptoms measured using PHQ-9
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068390
|Contact: Debra K Moser, PhDemail@example.com|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40535|
|Contact: Debra K Moser, PhD, RN 859-323-6687 firstname.lastname@example.org|
|Contact: Theresa Back, MS, MN 859-323-6656 email@example.com|
|Principal Investigator: Debra K Moser, PhD, RN|
|Principal Investigator:||Debra K Moser, PhD||University of Kentucky|