CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Interactive Technology Enhanced Coaching (ITEC) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03577990
NCT03577990N/ACompleted

An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension

University of North Carolina, Charlotte·interventional·Posted Jul 5, 2018·Updated May 17, 2023

In Brief

A clinical study evaluating Interactive Technology Enhanced Coaching (ITEC) and Interactive Technology-No Coaching (IT) for Uncontrolled Hypertension. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 5, 2018
Enrollment StartJan 28, 2019
Primary CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.0 years ago

Interventions

Interactive Technology Enhanced Coaching (ITEC)behavioral

As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.

Interactive Technology-No Coaching (IT)behavioral

After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.