Clinical trial NCT03577990: Technology Coaching Intervention for Black Women With Hypertension
Official title: An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: hypertension, Black women, self-management, coaching
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-07-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure (BP)
timeFrame: Baseline to 3 months, 6 months, and 9 months.
Secondary outcomes:
measure: Medication Adherence by Proportion of Days Covered
timeFrame: Month 1 to Month 3, Month 6, and Month 9.
measure: Physical Activity (Change in Daily Steps)
timeFrame: Month 1 to Month 3, Month 6, and Month 9.
measure: Change in Dietary Intake (Calories)
timeFrame: Month 1 to Month 3, Month 6, and Month 9.
measure: Change in Weight
timeFrame: Baseline to 3 months, 6 months, and 9 months.
measure: Change in Dietary Intake (Sodium)
timeFrame: Month 1 to Month 3, Month 6, and Month 9.
Other outcomes:
measure: Stigma and Hypertension, Qualitative Study
timeFrame: 15 minutes
Locations:
city: Charlotte
country: United States
facility: Churches, Salons, Community Events
state: North Carolina
Study officials:
affiliation: The University of North Carolina at Charlotte
name: Willie M Abel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of North Carolina at Charlotte
name: Mark J DeHaven, PhD
role: STUDY_DIRECTOR
References:
citation: 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.