Implementation of Heart Matters Evidence-based Program
Overview
- Phase
- Not Applicable
- Intervention
- Heart Matters
- Conditions
- Cardiovascular Diseases
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 173
- Locations
- 9
- Primary Endpoint
- Mean change from Baseline, Systolic Blood Pressure
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.
Detailed Description
The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators. This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Identify as Black or African American
- •Reside in rural, eastern North Carolina
- •Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease
Exclusion Criteria
- •Evidence of active or unstable cardiovascular disease
- •Cognitive impairment that limits informed consent
Arms & Interventions
Intervention Group
This group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm.
Intervention: Heart Matters
Propensity-matched Control Group (Retrospective)
This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.
Intervention: Heart Matters
Outcomes
Primary Outcomes
Mean change from Baseline, Systolic Blood Pressure
Time Frame: Baseline, 6 Months
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
Mean change from Baseline, Diastolic Blood Pressure
Time Frame: Baseline, 6 Months
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
Secondary Outcomes
- Number of Participants with Personal History of Cardiovascular Disease(Baseline)
- Number of Participants with Family History of Cardiovascular Disease(Baseline)
- Mean Systolic Blood Pressure in mmHg(Baseline, 6 Months, 12 Months)
- Mean Diastolic Blood Pressure in mmHg(Baseline, 6 Months, 12 Months)
- Mean Body-mass Index(Baseline, 6 Months, 12 Months)
- Mean Weight in Pounds(Baseline, 6 Months, 12 Months)
- Mean Waist Circumference in Centimeters(Baseline, 6 Months, 12 Months)
- Mean Total Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Blood Triglycerides in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Glycated Hemoglobin (A1C) Score(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Smoking Status(Baseline, 6 Months, 12 Months)
- Mean Healthy Days(Baseline, 6 Months, 12 Months)
- Mean Heart Disease Fact Questionnaire Score(Baseline, 6 Months, 12 Months)
- Mean University of Rhode Island Change Assessment Score(Baseline, 6 Months, 12 Months)
- Mean Perceived Stress Scale Score(Baseline, 6 Months, 12 Months)
- Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score(Baseline, 6 Months, 12 Months)
- Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Soda(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Water(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Fruit(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Chips(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Fish(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Eggs(Baseline, 6 Months, 12 Months)