N/A N=90 Randomized Treatment

Technology Coaching Intervention for Black Women With Hypertension

Uncontrolled Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT03577990 ↗

Enrolled (actual)

Serious AEs

14.5%

Results posted

May 2023

Primary outcome: Primary: Change in Systolic and Diastolic Blood Pressure (BP) — 140.07; 139.03; 124.18; 128.31 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Interactive Technology Enhanced Coaching (ITEC) (Behavioral); Interactive Technology-No Coaching (IT) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of North Carolina, Charlotte
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic and Diastolic Blood Pressure (BP)	140.07; 139.03; 124.18; 128.31; 125.80; 126.13	—
SECONDARY Medication Adherence by Proportion of Days Covered	0.7404; 0.6507; 0.5575; 0.5357; 0.6507; 0.5595	.05
SECONDARY Physical Activity (Change in Daily Steps)	5778.58; 5384.34; 4720.90; 6413.73; 4743.20; 5092.30	.05
SECONDARY Change in Dietary Intake (Calories)	1204.75; 1133.66; 801.42; 803.38; 1247.33; 1029.74	.05
SECONDARY Change in Weight	213.54; 214.31; 205.23; 212.20; 203.71; 203.71	—
SECONDARY Change in Dietary Intake (Sodium)	1363.65; 1386.61; 775.66; 928.30; 1226.89; 1512.05	.05

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03577990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.