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RICHH Intervention for Cardiovascular Risk (RICHH Trial)

N/A
Waitlist Available
Led By Debra K Moser, PhD
Research Sponsored by Debra Moser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 and 12 months
Awards & highlights

RICHH Trial Summary

This trial is testing the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH) on cardiovascular risk factors, self-management behaviors, and depressive symptoms in caregivers of adults with chronic illnesses. The study will compare the outcomes of the intervention group to a usual care group, and will also test the moderating effect of gender on intervention outcomes.

RICHH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Pressure in mmHg
Change in Body Mass Index (kg/m2) calculated from height and weight
Change in Lipid Profile Derived from point-of-care testing
Secondary outcome measures
Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study
Change in Depressive Symptoms
Change in Diet Quality measured by the Food Frequency Questionnaire
+1 more

RICHH Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RICHH InterventionExperimental Treatment1 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.
Group II: Usual careActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RICHH Intervention
2017
N/A
~320

Find a Location

Who is running the clinical trial?

Debra MoserLead Sponsor
2 Previous Clinical Trials
390 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,250 Total Patients Enrolled
2 Trials studying Cardiovascular Risk
815 Patients Enrolled for Cardiovascular Risk
Debra K Moser, PhDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any open opportunities to join this research experiment?

"The clinical trial in question is no longer actively recruiting patients, with the most recent update to its listing being made on September 12th 2022. This data can be found on clinicaltrials.gov; however, 82 other trials are still open for participants at this time."

Answered by AI

What effects are researchers expecting to observe from this trial?

"The primary objective of this clinical trial, evaluated at Baseline, 4 and 12 months intervals is to measure the Change in Blood Pressure (mmHg). Secondary outcomes include gauging improvement in Adherence by using a Specific Adherence Scale score from Medical Outcomes Study, assessing Diet Quality through Food Frequency Questionnaire data collection, and measuring Physical Activity Level with actigraphy-derived steps per 24 hours."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rural Intervention for Caregivers' Heart Health
Debra Moser 2017. "Rural Intervention for Caregivers' Heart Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03068390.
~38 spots leftby Apr 2025
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