N/A
Completed N=90
Technology Coaching Intervention for Black Women With Hypertension
Uncontrolled Hypertension
Source: ClinicalTrials.gov NCT03577990 ↗
Enrolled (actual)
90
Serious AEs
14.5%
Results posted
May 2023
Primary outcomePrimary: Change in Systolic and Diastolic Blood Pressure (BP) — 140.07; 139.03; 124.18; 128.31 mmHg
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.
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 |
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
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. Informational only — not medical advice.