Patient Navigation Program for Retention in Care

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Retention in Care+5 More
Patient Navigation Program - Behavioral
Eligibility
Any Age
Female
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Study Summary

This trial will assess whether a patient navigation intervention can improve health outcomes for women with a history of gestational diabetes.

Eligible Conditions
  • Retention in Care
  • Gestational Diabetes Mellitus (GDM)
  • Preventive Care / Anticipatory Guidance
  • Postpartum Health
  • Lifestyle Modification

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 4-12 weeks and 1 year postpartum

1 year postpartum
Assessment of postpartum glycemic control
Postpartum transition to primary care
Postpartum weight retention
Year 1
Abdominal circumference
Blood pressure
Diabetes risk perception
Diabetes self-efficacy
Participant experiences and perspectives on GDM
Patient activation
Patient experiences with navigation
Patient satisfaction with interpersonal relationship with navigator
Patient satisfaction with logistical aspects of navigation
4-12 weeks postpartum
Postpartum diabetes screening completion
Postpartum diabetes screening result
Postpartum visit attendance
Year 2
Dropout rate
Health care providers experiences with SWEET
Participant adherence with navigation
Proportion of eligible participants who enroll
Recruitment rate
Retention rate
Time to enrollment

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Non-navigation cohort
1 of 2
Navigation Group
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Patient Navigation Program · No Placebo Group · N/A

Navigation Group
Behavioral
Experimental Group · 1 Intervention: Patient Navigation Program · Intervention Types: Behavioral
Non-navigation cohortNoIntervention Group · 1 Intervention: Non-navigation cohort · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4-12 weeks and 1 year postpartum

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,122 Previous Clinical Trials
5,054,004 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,432 Previous Clinical Trials
769,497 Total Patients Enrolled
1 Trials studying Retention in Care
400 Patients Enrolled for Retention in Care
Lynn M Yee, MD, MPH4.8136 ReviewsPrincipal Investigator - Northwestern University
Medical School - Eastern Virginia Medical School, Doctor of Medicine
University of Southern California, Residency in Internal Medicine
2 Previous Clinical Trials
480 Total Patients Enrolled
1 Trials studying Retention in Care
400 Patients Enrolled for Retention in Care
5Patient Review
The level of care and professionalism was excellent. I appreciate that they were able to stay on schedule.

Eligibility Criteria

Age Any Age · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a patient of the Northwestern Medicine obstetrics and gynecology practices.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.