Technology Coaching Intervention for Black Women With Hypertension

Not Applicable

Completed

Conditions: Uncontrolled Hypertension

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

Registration Number: NCT03577990

Lead Sponsor: University of North Carolina, Charlotte

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 90

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive Technology Enhanced Coaching (ITEC)	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.
Interactive Technology-No Coaching (IT)	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.

Primary Outcome Measures

Name	Time	Method
Change in Systolic and Diastolic Blood Pressure (BP)	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.

Secondary Outcome Measures

Name	Time	Method
Medication Adherence by Proportion of Days Covered	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.
Change in Dietary Intake (Calories)	Month 1 to Month 3, Month 6, and Month 9.	To show the change (decrease) in dietary intake (calories) over 9 months.
Change in Dietary Intake (Sodium)	Month 1 to Month 3, Month 6, and Month 9.	To show the change (decrease) in dietary intake (sodium) over 9 months.
Physical Activity (Change in Daily Steps)	Month 1 to Month 3, Month 6, and Month 9.	To show the change (increase) in daily steps over 9 months.
Change in Weight	Baseline to 3 months, 6 months, and 9 months.	To show the change (decrease) in weight over 9 months.