Technology Coaching Intervention for Black Women With Hypertension

University of North Carolina, Charlotte

Status: Completed

Conditions: Uncontrolled Hypertension

Treatments: Behavioral: Interactive Technology Enhanced Coaching (ITEC); Behavioral: Interactive Technology-No Coaching (IT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03577990

17-0549

1K01HL140288 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Interactive Technology Enhanced Coaching (ITEC)

Experimental group

Description:

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.

Treatment:

Behavioral: Interactive Technology Enhanced Coaching (ITEC)

Interactive Technology-No Coaching (IT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interactive Technology-No Coaching (IT)