Clinical Trials Logo

Clinical Trial Summary

Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of hypertension in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling hypertension using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive self-care management and interactive coaching with technology will have lower systolic/diastolic BP and better adherence to antihypertensive medication(s) and lifestyle recommendations post intervention compared to participants receiving self-care management alone.

Clinical Trial Description

This study includes a sample of Black women with uncontrolled HTN. All participants meeting study eligibility requirements will receive the Chronic Disease Self-management Program (CDSMP) sessions for 6 weeks. Participants from this pool will be randomized to the treatment and control arm.

The treatment arm will include electronic monitoring of participants' BP, weight, physical activity, food diary, and medication-taking in real-time with weekly interactive technology enhanced coaching (ITEC), while the control arm will receive electronic monitoring with limited sham coaching.

Our sample of n=45 participants per arm (N=90 in total), will be measured at baseline, at 3 months, and at 6 months post CDSMP. A hierarchical, mixed-effects repeated measures design will be used to analyze the data.

The project is a two-arm randomized controlled trial with specific aims to determine whether the effects of CDSMP combined with ITEC will maintain BP control, attain medication adherence, and achieve lifestyle modifications compared to the CDSMP alone. We will test the hypothesis that:

1. More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3 months and at 6 months post CDSMP, compared to participants in CDSMP alone.

2. More participants in the CDSMP/ITEC arm will have higher levels of adherence to antihypertensive medication(s) at 3 months and at 6 months post CDSMP, compared to participants in the CDSMP alone.

3. More participants in the CDSMP/ITEC arm, will have higher levels of adherence to lifestyle modifications (physical activity, diet, and weight management) at 3 months and at 6 months post CDSMP, compared to participants in the CDSMP alone.

Information from this study may be used to enhance self-care management, control blood pressure, and increase the quality of life for Black women who are burdened with the adverse effects of hypertension and its high disability and mortality rates. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03577990
Study type Interventional
Source University of North Carolina, Charlotte
Contact Willie M Abel, PhD
Phone 704-687-7949
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date February 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03221114 - Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease N/A
Terminated NCT01966952 - Evaluation of Safety Mechanisms of Renal Radioablation(RSRA)for Uncontrolled Hypertension N/A
Withdrawn NCT01939392 - Rapid Renal Sympathetic Denervation for Resistant Hypertension II Phase 2/Phase 3
Completed NCT01699529 - Multi-electrode Radiofrequency Renal Denervation System Feasibility Study N/A
Completed NCT01418261 - SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension N/A
Active, not recruiting NCT01635998 - Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation N/A
Enrolling by invitation NCT02674464 - Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project) N/A
Completed NCT01996033 - EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension N/A
Terminated NCT01628198 - Impact of Renal SympAthetic DenerVation on Chronic HypErtension N/A
Not yet recruiting NCT03348878 - Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients N/A
Completed NCT02006758 - Observational Study of the EnligHTN Renal Denervation System in Europe N/A
Completed NCT02418091 - Integrated Population Program for Diabetic Kidney Disease N/A
Completed NCT00888433 - Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) N/A
Completed NCT01644604 - Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension N/A
Recruiting NCT03209154 - An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment N/A
Recruiting NCT03281772 - Uncontrolled Hypertension Management (TEAM-HTN)
Completed NCT02334033 - Cystatin C and Uncontrolled Hypertension N/A
Recruiting NCT02164435 - Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation N/A
Suspended NCT01679132 - BAROSTIM NEO HTN Pivotal Trial N/A
Completed NCT01628172 - Renal Sympathetic Denervation for the Management of Chronic Hypertension N/A