Technology Coaching Intervention for Black Women With Hypertension

April 23, 2023 updated by: Willie Abel, University of North Carolina, Charlotte

An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension

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 HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm will receive electronic monitoring (of participants' BP, weight, physical activity, food diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC) while the control arm will receive usual care with manual BP measurements monthly. At Step 2 for three months, the treatment arm will receive electronic monitoring with ITEC biweekly, and the control arm will receive electronic monitoring only. At Step 3 for three months, both the treatment arm and the control arm will receive electronic monitoring only.

Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic measurements, anthropometric measurements, and data collection tools) at baseline, 3 months, 6 months, and at 9 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 (physical activity, diet, and weight management) 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, 6 months, and at 9 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, 6 months, and at 9 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, 6 months, and at 9 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 HTN and its high disability and mortality rates.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28223
        • Churches, Salons, Community Events

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Self-identified as Black or African American;
  • 18-70 years of age
  • English speaking
  • Has to live in the study community, Charlotte or surrounding area
  • Systolic BP greater than or equal to 130 and/or diastolic BP greater than or equal to 80 at screening
  • Prescribed to take one or more antihypertensive medication(s)
  • Smartphone or device
  • Bluetooth 4.0 and Provider network or Wi-Fi connectivity

Exclusion Criteria:

  • Self-report of mental illness that interferes with daily functioning
  • Unable to be physically active
  • Current pregnancy
  • Plans to move from the study area during the project
  • Systolic BP greater than or equal to 160 and/or diastolic BP greater than or equal to 100
  • Uncontrolled diabetes (HbA1c >8.5), hemodialysis, stroke (within past year with residual effects such as weakness, paralysis, speech difficulty, etc.), cancer treatment (for spread of cancer to other places in the body), or a heart attack (within the past year)
  • Concurrent participation in another research study and/or taken any Stanford self-management program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive Technology Enhanced Coaching (ITEC)
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Behavioral: Interactive Technology Enhanced Coaching (ITEC)
As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Active Comparator: Interactive Technology-No Coaching (IT)
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Behavioral: Interactive Technology-No Coaching (IT)
After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic and Diastolic Blood Pressure (BP)
Time Frame: Baseline to 3 months, 6 months, and 9 months.
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
Baseline to 3 months, 6 months, and 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence by Proportion of Days Covered
Time Frame: Month 1 to Month 3, Month 6, and Month 9.
To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100.
Month 1 to Month 3, Month 6, and Month 9.
Physical Activity (Change in Daily Steps)
Time Frame: Month 1 to Month 3, Month 6, and Month 9.
To show the change (increase) in daily steps over 9 months.
Month 1 to Month 3, Month 6, and Month 9.
Change in Dietary Intake (Calories)
Time Frame: Month 1 to Month 3, Month 6, and Month 9.
To show the change (decrease) in dietary intake (calories) over 9 months.
Month 1 to Month 3, Month 6, and Month 9.
Change in Weight
Time Frame: Baseline to 3 months, 6 months, and 9 months.
To show the change (decrease) in weight over 9 months.
Baseline to 3 months, 6 months, and 9 months.
Change in Dietary Intake (Sodium)
Time Frame: Month 1 to Month 3, Month 6, and Month 9.
To show the change (decrease) in dietary intake (sodium) over 9 months.
Month 1 to Month 3, Month 6, and Month 9.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stigma and Hypertension, Qualitative Study
Time Frame: 15 minutes
Qualitative questionnaire (included written responses to two open-ended questions) to gain insight and describe the psychological factor of stigma as an influence on poorly controlled hypertension in Black women. No scale was used to assess data.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Charlotte

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Willie M Abel, PhD, The University of North Carolina at Charlotte
  • Study Director: Mark J DeHaven, PhD, The University of North Carolina at Charlotte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

April 16, 2021

Study Completion (Actual)

April 16, 2021

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0549
  • 1K01HL140288 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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