Chronic Hypertension, Gestational Hypertension, Hypertension in Pregnancy
Conditions
Keywords
Hypertension in pregnancy, Moms@Home, Mobile health intervention, Blood pressure, Blood pressure management, Hypertension, Gestational hypertension, Storytelling, Home blood pressure monitoring, Storytelling mobile intervention
Brief summary
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.
Detailed description
The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women with Hypertension (HTN). The study will integrate three components to improve BP care and outcomes: 1) the Moms@Home mobile app to promote HBPM through storytelling videos and a patient dashboard of BP data, 2) a digital BP monitor for HBPM, and 3) an HBPM report that curates and shares key health data with the right provider at the right time. Designed by and for pregnant women with HTN across racial/ethnic groups, the Moms@Home intervention is novel because it leverages digital health, behavior change techniques, and culturally relevant storytelling to improve HTN self-care while facilitating patient/caregiver communication through an HBPM report. Investigators are conducting a pilot randomized controlled trial (RCT) of Moms@Home vs. enhanced standard care, with plans to enroll 100 pregnant women (50% from racial/ethnic minority groups) with gestational or chronic HTN to determine whether Moms@Home vs. enhanced standard care (BP monitor, diary) improves HBPM adherence (primary outcome) and to evaluate the feasibility, acceptability, and sustainability of the intervention.
Interventions
BEHAVIORALMoms@Home
Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.
BEHAVIORALEnhanced Standard of Care
Participants will use a paper journal daily to track home-based blood pressure values
Sponsors
University of Massachusetts, Worcester
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to the randomization assignments. Both investigators and participants will be aware of the randomization assignments to facilitate the implementation of the interventions.
Intervention model description
Participants will be randomized to receive either the Moms@Home intervention or ESC through permuted blocked randomization, in blocks of multiples of 2 such that half of the participants will use Moms@Home and the other half ESC.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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, * A patient of the University of Massachusetts Memorial Health Obstetrics/Maternal and Fetal Medicine clinics in Worcester, Massachusetts * Willing to share home blood pressure monitoring data * Comfortable with the use of smartphones and mobile apps
Exclusion criteria
* 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) * Enrolled in another home blood pressure monitoring program * Excluded from study participation by their provider * Inability to provide informed consent * Prisoners/institutionalized individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Home Blood Pressure Monitoring Adherence | 8 weeks | Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week |
| Feasibility of the Moms@Home intervention | 8 weeks | 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 | 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy | Baseline, 4 weeks, 8 weeks | 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 | 8 weeks | 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 | Baseline, 4 weeks, 8 weeks | 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 | 4 weeks, 8 weeks | 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. |
| Medication Adherence | Baseline, 4 weeks, 8 weeks | On a numeric scale, baseline and change in medication adherence will be assessed through a baseline, midpoint and post-intervention survey. |
| Medication titration | Baseline, 4 weeks, 8 weeks | Medication titration will be assessed based on any changes in the blood pressure medications participants are taking. These changes may include adjustments in dosage, discontinuation of medications, initiation of new medications, or switching between different medications. This data will be obtained from participants' electronic health records. |
| Goal attainment | Baseline, 8 weeks | Attainment of personal goals related to home blood pressure monitoring set at the study baseline will be assessed with a post-intervention survey and reported as a percentage of goal achieved. |
| Physical Activity | Baseline, 4 weeks, 8 weeks | On numeric scale, baseline and change in physical activity will be tracked by daily steps recorded by the FitBit. |
Countries
United States
Contacts
CONTACTLara Kovell, MD,MSc
CONTACTAbigail Arthur, MBChB, MPH
PRINCIPAL_INVESTIGATORLara Kovell, MD,MSc
University of Massachusetts Medical School, Worcester
Outcome results
None listed