Technology Coaching Intervention for Black Women With Hypertension

• ClinicalTrials.gov Identifier: NCT03577990
• Recruitment Status: Completed
• First Posted: July 5, 2018
• Last Update Posted: October 28, 2021
• Sponsor: University of North Carolina, Charlotte
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Willie Abel, University of North Carolina, Charlotte

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Uncontrolled Hypertension	Behavioral: ITEC; Behavioral: No ITEC	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension
• Actual Study Start Date: January 28, 2019
• Actual Primary Completion Date: April 16, 2021
• Actual Study Completion Date: April 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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: 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: No ITEC; 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: No ITEC; 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 ITEC. 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Systolic and Diastolic Blood Pressure (BP) [ Time Frame: Study participants will be assessed for changes at baseline, 3 months, 6 months, and 9 months. ]
   BP will be measured according to the American Heart Association Guidelines for home BP monitoring. Track daily BP measurements electronically for changes and compare with Self-Care of Hypertension Inventory, Self-Efficacy for Managing Chronic Disease, and Healthcare Utilization tools.

Secondary Outcome Measures :

1. Medication Adherence [ Time Frame: Assess for changes at baseline, 3 months, 6 months, and 9 months. ]
   Compare daily self-reported medication adherence electronically and with Hill-Bone High Blood Pressure Compliance Scale to change in BP.
2. Physical activity [ Time Frame: Assess for changes at baseline, 3 months, 6 months, and 9 months. ]
   Compare daily steps using Fitbit activity tracker electronically to change in BP.
3. Diet Tracking [ Time Frame: Assess for changes at baseline, 3 months, 6 months, and 9 months. ]
   Compare daily self-reported caloric intake electronically to change in BP.
4. Weight Management [ Time Frame: Assess for changes at baseline, 3 months, 6 months, and 9 months. ]
   Compare daily weight measurement electronically to change in BP.

Other Outcome Measures:

1. Stigma and Hypertension [ Time Frame: Baseline ]
   Qualitative stigma questionnaire (includes two open-ended questions, no scale) to gain insight and describe the psychological factor of stigma as an influence on poorly controlled HTN in Black women.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Churches, Salons, Community Events

Charlotte, North Carolina, United States, 28223

Sponsors and Collaborators

University of North Carolina, Charlotte

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Willie Abel, Assistant Professor, University of North Carolina, Charlotte
• ClinicalTrials.gov Identifier: NCT03577990
• Other Study ID Numbers: 17-0549; 1K01HL140288 ( U.S. NIH Grant/Contract )
• First Posted: July 5, 2018
• Last Update Posted: October 28, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Willie Abel, University of North Carolina, Charlotte:

hypertension, Black women, self-management, coaching

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases