Technology Coaching Intervention for Black Women With Hypertension

NCT03577990 | Completed Results DMC

• 2 other identifiers: 17-05491K01HL140288
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Uncontrolled Hypertension

Keywords

hypertension, Black women, self-management, coaching

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and Diastolic Blood Pressure (BP)

  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 Outcomes (5)

• Medication Adherence by Proportion of Days Covered

  Month 1 to Month 3, Month 6, and Month 9.

• Physical Activity (Change in Daily Steps)

  Month 1 to Month 3, Month 6, and Month 9.

• Change in Dietary Intake (Calories)

  Month 1 to Month 3, Month 6, and Month 9.

• Change in Weight

  Baseline to 3 months, 6 months, and 9 months.

• Change in Dietary Intake (Sodium)

  Month 1 to Month 3, Month 6, and Month 9.

Other Outcomes (1)

• Stigma and Hypertension, Qualitative Study

  15 minutes

Study Arms (2)

Interactive Technology Enhanced Coaching (ITEC)

EXPERIMENTAL

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)

Interactive Technology-No Coaching (IT)

ACTIVE COMPARATOR

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)

Interventions

Interactive Technology Enhanced Coaching (ITEC) BEHAVIORAL

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.

Interactive Technology Enhanced Coaching (ITEC)

Interactive Technology-No Coaching (IT) BEHAVIORAL

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.

Interactive Technology-No Coaching (IT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified as Black or African American;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Charlotte: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Churches, Salons, Community Events

Charlotte, North Carolina, 28223, United States

Location

Related Publications (2)

• Abel WM, Spikes T, Greer DB. A Qualitative Study: Hypertension Stigma Among Black Women: Erratum. J Cardiovasc Nurs. 2025 May-Jun 01;40(3):279. doi: 10.1097/JCN.0000000000001213. No abstract available.

  PMID: 40198262 DERIVED

• Abel WM, DeHaven MJ. An interactive technology enhanced coaching intervention for Black women with hypertension: Randomized controlled trial study protocol. Res Nurs Health. 2021 Feb;44(1):24-36. doi: 10.1002/nur.22090. Epub 2020 Dec 15.

  PMID: 33319386 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Willie M. Abel, Associate Professor of Nursing
• Organization: The University of North Carolina at Charlotte

wmabel@uncc.edu

704-687-7949

Study Officials

• Willie M Abel, PhD

  The University of North Carolina at Charlotte

  PRINCIPAL INVESTIGATOR

• Mark J DeHaven, PhD

  The University of North Carolina at Charlotte

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will test the effects of ITEC added to CDSMP on two study aims: 1) BP control, and 2) adherence to antihypertensive medication and lifestyle modifications. After baseline data collection, participants complete a 6-week CDSMP course and then are randomly assigned to either the treatment or control arm. All participants will continue to receive usual care for HTN. The treatment group will receive ITEC and wireless tools to track activity, BP, weight, food intake, and self-report medication-taking after an orientation to Fitbit Plus (a cloud-based collaborative care platform designed to store and track data). All tools will be synced to the participants' smartphone. The treatment arm will receive weekly ITEC for 3 months, biweekly ITEC for 3 months, and then no ITEC for 3 months. The control arm will receive usual care only with monthly BP measured manually for 3 months and then receive the same wireless tools with monitoring to track comparative data with the treatment arm.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: July 5, 2018
• Study Start: January 28, 2019
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)