NCT01884246: HeartHealth

Improving Heart Health in Appalachia

Completed NA Last updated 10 March 2017

What this trial tests

NA trial testing Self-care CVD risk reduction in Obesity in 330 participants. Completed in 31 December 2016.

Timeline

1 August 2013

Primary endpoint
31 December 2016

31 December 2016

Quick facts

Lead sponsor	Debra Moser
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	330
Start date	1 August 2013
Primary completion	31 December 2016
Estimated completion	31 December 2016
Sites	1 location across United States

Drugs / interventions tested

• Self-care CVD risk reduction
• Referral to primary care provider for CVD risk management

Conditions studied

• Obesity — all drugs for Obesity →
• Hypertension — all drugs for Hypertension →
• Hyperlipidemia — all drugs for Hyperlipidemia →
• Depression — all drugs for Depression →

Sponsor

Debra Moser

Who can join

21 and older, any sex, with Obesity or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the absence of such interventions, the dramatic CVD disparities seen in this area will continue to rise.

Lifestyle interventions reduce CVD risk by 44%. The investigators and others have demonstrated that lifestyle change is most effective when patients are given the tools to engage in effective self-care, and that interventions individualized to patients' specific needs and barriers are more effective than interventions that are not. The central hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must focus on patient-centered lifestyle change that increase individuals' abilities to engage in self-care, must be culturally appropriate, and must have components that overcome barriers faced by individuals living in Appalachia.

The investigators propose a randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider and who are at risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success with (2) referral of patients to a primary care provider for management of their CVD risk factors. The investigators propose the following specific aims to be tested at 4 months and 1 year after baseline. To compare the short and long-term impact of the interventions on:

1\) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile, hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction measures, and retention of recruited individuals. The investigators hypothesize that in comparison to the referral strategy, the multifaceted patient-centered, self-care intervention will engender more favorable outcomes across all measures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.