Evaluation of MHP 3.0 in Two Clinical Settings
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Telemedicine
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
For this study the investigators pilot MHP products in two clinical settings to determine their acceptability and feasibility in clinical practice. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the U...
For this study the investigators pilot MHP products in two clinical settings to determine their acceptability and feasibility in clinical practice. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC Healthcare System for a 1-year period. Participants will receive MHP to use as part of their prenatal care, along with communication from the prescribing provider about how the app will be used and when the provider will have access to their information. Population and Sample Size: The investigators will recruit a sample of 75 patients from each clinical site in women's first trimester of pregnancy. In the case of Obstetrix Medical Group of Houston, the investigators will oversample for Spanish speakers (approximately 20% of our population). Women will be eligible for recruitment if they are at least 18 years old, are currently pregnant and under the care of a participating provider/clinic, own a smartphone, and are literate in English or Spanish. A site coordinator will identify eligible women to match our demographic requirements and introduce the study during an initial prenatal appointment, then consent women to the study. Data sources and collection (patients): A short acceptability and feasibility survey will be administered by the Naima Health team by phone three times during the study term. A final questionnaire will be conducted by phone between weeks 36-42 to review their psychosocial screening experience. Analytic Plan and Sample Size Considerations: The investigators will focus on feasibility (a priori defined as ? 67% completion of weekly questionnaires administered through the app) and acceptability (a priori defined as satisfaction scores of ? 4 on a 7-point Likert scale among ?80% participants) as primary outcomes for this aim. Descriptive statistics will be used to characterize baseline demographic characteristics of the participants. The investigators will use point estimates (i.e. means and sample proportions) and 95% confidence intervals to characterize the sample with respect to baseline demographic characteristics. Debriefing interview transcripts will be coded for themes of acceptability, satisfaction, and barriers to app use.
Tracking Information
- NCT #
- NCT04863521
- Collaborators
- University of Pittsburgh
- Obstetrix Medical Group
- Investigators
- Not Provided