NCT03305003

Brief Summary

Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that provides week by week information about pregnancy, preventive health messages, appointment information, and space to record their experiences throughout their pregnancy. When used accordingly, the evidence-based guide is an effective tool for motivating patients to participate in their own healthcare and achieve care goals. However, the spiral-bound paper modality results in patients forgetting the book for appointments or losing it. By testing a mobile application (app) from the current publication, the MHS leverages the efforts which created the guide while increasing patient and provider use. The multisite testing (randomized controlled trial) of a mobile application developed from the current spiral-bound "Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care" created by the VA and DoD provides an innovative, cost-effective opportunity to improve provider-patient communication and patient care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

September 26, 2017

Last Update Submit

October 3, 2017

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

  • Portability across time

    Question if a patient brings tool to appointments and uses it between appointments

    16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation

  • Patient activation across time

    Patient activation, defined as the knowledge, skills, and confidence to self-manage health

    8-10 weeks gestation, 32 weeks gestation

  • Prenatal Interpersonal Processes of Care across time

    Patient perception of the prenatal providers communicative behavior

    16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation

Study Arms (2)

Communication modality: spiral notebook

ACTIVE COMPARATOR
Other: Spiral notebook

Communication modality: mobile application

EXPERIMENTAL
Other: Mobile application

Interventions

Spiral notebookOTHER
Communication modality: spiral notebook
Mobile applicationOTHER
Communication modality: mobile application

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women (older than 18 years) who initiate obstetrics care (in the Women's Health or Family Health clinics) at the three sites.

You may not qualify if:

  • Cardiovascular disease
  • Cardiac abnormality
  • Diabetes Mellitus - Type I or Type II
  • Renal disorder
  • Uncontrolled hypertension
  • HIV positive
  • Hepatitis B or C positive
  • History of syphilis/RPR positive
  • Uncontrolled thyroid disease
  • History of previous bariatric surgery
  • Hematologic conditional with the exception of mild anemia
  • Cancer: current or recurrent
  • History of seizure disorder or other neurological condition
  • History of lupus or other autoimmune disorder
  • Antiphospholipid syndrome
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ledford CJW, Canzona MR, Cafferty LA, Hodge JA. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot. Patient Educ Couns. 2016 Apr;99(4):578-582. doi: 10.1016/j.pec.2015.11.006. Epub 2015 Nov 10.

    PMID: 26610389BACKGROUND

  • Ledford CJW, Womack JJ, Rider HA, Seehusen AB, Conner SJ, Lauters RA, Hodge JA. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial. Health Educ Behav. 2018 Jun;45(3):323-330. doi: 10.1177/1090198117732110. Epub 2017 Sep 16.

    PMID: 28918669RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 9, 2017

Study Start

May 1, 2015

Primary Completion

August 30, 2015

Study Completion

December 31, 2015

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share