About this trial
This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-50
English or Spanish speaking
A diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age)
Singleton or multiple gestation pregnancy,
Disqualifiers
Severe hypertension (Systolic blood pressure ≥160 mmHg or Diastolic blood pressure ≥100 mmHg)
Current diagnosis of preeclampsia
Active substance use
Serious physical illness (e.g., unable to interact with a smart device)
Trial design
Parallel
Treatments tested in this trial
Moms@Home
BehavioralParticipants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.
Enhanced Standard of Care
BehavioralParticipants will use a paper journal daily to track home-based blood pressure values
Treatment groups
Trial outcomes
Primary outcomes
Home Blood Pressure Monitoring Adherence
Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week
Feasibility of the Moms@Home intervention
Among the participants in the intervention group, the feasibility of the Moms@Home intervention will be assessed through a post-intervention survey using a 5-point Likert scale, with questions on the value and overall satisfaction with the mobile intervention app. On a numeric scale, number of screened and eligible participants and the number/reason(s) for declining participation or withdrawal will be tracked.
Acceptability
Acceptability will be assessed using the System Usability Scale (SUS) and the perceived impact section of the End-user Mobile Application Rating Scale (uMARS). These are both validated measures of the usability/quality of mobile health apps. SUS is scored on a 0-100 scale, a higher score meaning better usability. The uMARS is scored on a 5-point Likert scale, with the total score calculated by averaging the scores across the items within the perceived impact subscale.
Secondary outcomes
Self-Efficacy
Change in self-efficacy will be determined through the Self-Efficacy to Manage Hypertension scale (Warren-Findlow, 2012). Each item of this scale is scored on a 1 to 10 scale, with the total score calculated by averaging the scores across the items. Higher mean scores indicate higher self-efficacy.
Sustainability
The sustainability of the Moms@Home intervention will be assessed through a post-intervention survey using a 5-point Likert scale, evaluating participants' perceptions of whether the Moms@Home storytelling mobile app could be continued beyond the study period.
Blood Pressure (BP) measures
Home Blood Pressure Monitoring (HBPM) values will be assessed using blood pressure data collected from the Moms@Home app and paper BP diaries. Clinic blood pressure values will be obtained through a review of electronic health records.
Engagement with Moms@Home
Among the participants in the intervention group, engagement with the Moms@Home intervention will be measured on a numeric scale by number of logins, time spent in the app, surveys completed, and storytelling videos watched.
Other outcomes
Focus group interviews
The investigators will perform qualitative focus groups in a subpopulation of the Moms@Home study assignment to assess for ease of use, barriers and facilitators related to the intervention and long-term maintenance.
Sponsors and contacts
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University of Massachusetts, Worcester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator