CClinicalTrials.gg
Enrolling by invitationNCT07747519MVPUpdated Aug 5, 2026

Addressing Postpartum Visit Attendance Through Mobile Health: A Feasibility Pilot Randomized Controlled Trial of Postpartum Mobile Van Visits

An interventional study of Clinic Postpartum Care and Mobile Postpartum Care in Postpartum and Neonatal, sponsored by Women and Infants Hospital of Rhode Island. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The goal of this clinical trial is to learn whether offering postpartum checkups in a mobile medical van makes it easier for new mothers to complete their postpartum care after giving birth at Women \& Infants Hospital. The main questions it aims to answer are: Does having a postpartum visit in a mobile medical van make it easier for patients to attend their postpartum checkup? Are patients as satisfied with postpartum care provided in the mobile van as they are with care provided in the clinic? Researchers will compare postpartum visits completed in the mobile medical van with postpartum visits completed in the clinic to see whether the mobile van improves access to postpartum care and the patient experience. Participants will: 1. Be randomly assigned to have their postpartum visit either in the mobile medical van or at the clinic. 2. Complete a standard postpartum checkup with a healthcare provider. 3. Fill out a few short surveys about their experience with their postpartum care.

02

Conditions studied

  • Postpartum
  • Neonatal

Keywords

  • Postpartum Care
  • Postpartum Mobile Care
  • Postpartum Mobile Visits
  • Mobile Van
  • Postpartum Appointment
03

In context

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 years or older
  • Delivered a live infant at Women \& Infants Hospital
  • Reside within the geographic area serviced by the mobile van
  • Plans to remain in the area for at least 3 months postpartum
  • Able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe maternal medical complications requiring prolonged inpatient postpartum care (e.g., ICU stay beyond routine recovery)
  • Plans to relocate outside the mobile van service area within 3 months postpartum
  • Cognitive impairment or psychiatric conditions that would interfere with the ability to provide informed consent or participate in study procedures
  • Participation in another postpartum intervention study that may influence visit attendance or care delivery
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Clinic Postpartum Visit

    Participants receive their routine postpartum visit in the outpatient clinic according to standard practice.

    Other: Clinic Postpartum Care

  • Active comparator
    Mobile Postpartum Visit

    Participants receive their routine postpartum visit in a mobile medical van located in their community. The visit includes the same standard postpartum care that would be provided in the outpatient clinic.

    Other: Mobile Postpartum Care

Interventions

  • OtherClinic Postpartum Care

    Standard postpartum care delivered in the outpatient clinic.

  • OtherMobile Postpartum Care

    Standard postpartum care delivered in a mobile medical van instead of the traditional outpatient clinic.

06

What researchers measure

Primary outcomes

  1. To assess the feasibility of delivering postpartum care via a mobile health van by evaluating the proportion of planned visits successfully conducted in the mobile van.

    Time frame: Through study completion, approximately 1 year

Secondary outcomes

  1. Assess postpartum appointment attendance rates at the mobile van versus the standard in-person visit

    Time frame: Through study completion, approximately 1 year

Other outcomes

  1. Mean Trust in Physician Score Measured by the Trust in Physician Scale

    Mean trust in physician score measured using the Trust in Physician Scale (TPS), a validated patient-reported questionnaire that assesses participants' trust in their healthcare provider. The TPS consists of 11 items rated on a Likert scale, with item responses summed to generate a total score. Higher total scores indicate greater trust in the physician.

    Time frame: Through study completion, approximately 1 year

  2. Mean Cultural Humility Score Measured by the Cultural Humility Scale

    Mean cultural humility score measured using the Cultural Humility Scale (CHS), a validated patient-reported questionnaire that assesses participants' perceptions of culturally humble healthcare, including respect, openness, and responsiveness to individual cultural values and experiences. Item responses are summed or averaged according to the instrument's scoring guidelines to generate a total score. Higher scores indicate greater perceived cultural humility.

    Time frame: Through study completion, approximately 1 year

07

Study locations

1 site
  • Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02905, United States
08

References and documents

Publications

  • Edgerley LP, El-Sayed YY, Druzin ML, Kiernan M, Daniels KI. Use of a community mobile health van to increase early access to prenatal care. Matern Child Health J. 2007 May;11(3):235-9. doi: 10.1007/s10995-006-0174-z. Epub 2007 Jan 23. PubMed 17243022 ↗
  • Malone NC, Williams MM, Smith Fawzi MC, Bennet J, Hill C, Katz JN, Oriol NE. Mobile health clinics in the United States. Int J Equity Health. 2020 Mar 20;19(1):40. doi: 10.1186/s12939-020-1135-7. PubMed 32197637 ↗
  • Gibson J, McKenzie-McHarg K, Shakespeare J, Price J, Gray R. A systematic review of studies validating the Edinburgh Postnatal Depression Scale in antepartum and postpartum women. Acta Psychiatr Scand. 2009 May;119(5):350-64. doi: 10.1111/j.1600-0447.2009.01363.x. Epub 2009 Mar 2. PubMed 19298573 ↗
  • Bohnert KM, Breslau N. Assessing the performance of the short screening scale for post-traumatic stress disorder in a large nationally-representative survey. Int J Methods Psychiatr Res. 2011 Mar;20(1):e1-5. doi: 10.1002/mpr.331. PubMed 21516187 ↗
  • Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093. PubMed 18388841 ↗
  • Stucky BD, Gottfredson NC, Panter AT, Daye CE, Allen WR, Wightman LF. An item factor analysis and item response theory-based revision of the Everyday Discrimination Scale. Cultur Divers Ethnic Minor Psychol. 2011 Apr;17(2):175-185. doi: 10.1037/a0023356. PubMed 21604841 ↗
  • Foronda C, Baptiste DL, Reinholdt MM, Ousman K. Cultural Humility: A Concept Analysis. J Transcult Nurs. 2016 May;27(3):210-7. doi: 10.1177/1043659615592677. Epub 2015 Jun 28. PubMed 26122618 ↗
  • Hook JN, Davis DE, Owen J, Worthington EL, Utsey SO. Cultural humility: measuring openness to culturally diverse clients. J Couns Psychol. 2013 Jul;60(3):353-366. doi: 10.1037/a0032595. Epub 2013 May 6. PubMed 23647387 ↗
  • Lemon LS, Hauspurg A, Garrard W, Quinn B, Simhan HN. Neighborhood disadvantage and the racial disparity in postpartum hypertension. Am J Obstet Gynecol MFM. 2023 Jan;5(1):100773. doi: 10.1016/j.ajogmf.2022.100773. Epub 2022 Oct 13. PubMed 36244624 ↗
  • Mbuthia F, Reid M, Fichardt A. mHealth communication to strengthen postnatal care in rural areas: a systematic review. BMC Pregnancy Childbirth. 2019 Nov 6;19(1):406. doi: 10.1186/s12884-019-2531-0. PubMed 31694578 ↗
  • Yu SWY, Hill C, Ricks ML, Bennet J, Oriol NE. The scope and impact of mobile health clinics in the United States: a literature review. Int J Equity Health. 2017 Oct 5;16(1):178. doi: 10.1186/s12939-017-0671-2. PubMed 28982362 ↗
  • Attipoe-Dorcoo S, Delgado R, Gupta A, Bennet J, Oriol NE, Jain SH. Mobile health clinic model in the COVID-19 pandemic: lessons learned and opportunities for policy changes and innovation. Int J Equity Health. 2020 May 19;19(1):73. doi: 10.1186/s12939-020-01175-7. PubMed 32429920 ↗
  • Managed care and children with special health care needs: a subject review. American Academy of Pediatrics Committee on Children with Disabilities. Pediatrics. 1998 Sep;102(3 Pt 1):657-60. doi: 10.1542/peds.102.3.657. PubMed 9738195 ↗
  • Howell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349. PubMed 29346121 ↗
  • Kozhimannil KB, Hardeman RR, Alarid-Escudero F, Vogelsang CA, Blauer-Peterson C, Howell EA. Modeling the Cost-Effectiveness of Doula Care Associated with Reductions in Preterm Birth and Cesarean Delivery. Birth. 2016 Mar;43(1):20-7. doi: 10.1111/birt.12218. Epub 2016 Jan 14. PubMed 26762249 ↗
  • Danilack VA, Brousseau EC, Paulo BA, Matteson KA, Clark MA. Characteristics of women without a postpartum checkup among PRAMS participants, 2009-2011. Matern Child Health J. 2019 Jul;23(7):903-909. doi: 10.1007/s10995-018-02716-x. PubMed 30631991 ↗
  • ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633. PubMed 29683911 ↗

Study documents

  • Study protocol · Oct 1, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07747519
Lead sponsor
Women and Infants Hospital of Rhode Island
Collaborators
The William and Mary Oh-William and Elsa Zopfi Professorship in Pediatrics for Perinatal Research, The Danielle Peress, MD Memorial Fund
Responsible party
Efe Cudjoe (Maternal Fetal Medicine Fellow- Physician, Women and Infants Hospital of Rhode Island) — Principal investigator
First posted
Aug 5, 2026
Start date
Jun 17, 2026
Primary completion
Jun 17, 2027 (estimated)
Completion
Jun 17, 2027 (estimated)
Last update
Aug 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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