Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03577990 |
| Other study ID # |
17-0549 |
| Secondary ID |
1K01HL140288 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2019 |
| Est. completion date |
April 16, 2021 |
Study information
| Verified date |
April 2023 |
| Source |
University of North Carolina, Charlotte |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
