Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Massachusetts, Worcester

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Moms@Home

    Behavioral

    Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.

  • Enhanced Standard of Care

    Behavioral

    Participants will use a paper journal daily to track home-based blood pressure values

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Moms@Home armExperimental treatment 1 intervention
Group B: Enhanced Standard Care armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Home Blood Pressure Monitoring Adherence

Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 4 weeks, 8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
Baseline, 4 weeks, 8 weeks
4

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.

Time frame
4 weeks, 8 weeks

Other outcomes

1

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.

Time frame
At least 3 months after randomization

Sponsors and contacts

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University of Massachusetts, Worcester

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator