NCT04474795

Brief Summary

This study addresses education needs in gestational diabetes care and followup at the staff and patient levels. In the initial phase, nurses and community health workers will complete specific training modules on gestational diabetes developed for this study. The effectiveness of the education modules will be evaluated through pre/post surveys of participants assessing diabetes knowledge, attitudes, and self-efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 27, 2023

Completed
Last Updated

February 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

May 18, 2020

Results QC Date

January 30, 2023

Last Update Submit

January 30, 2023

Conditions

Keywords

diabetes in pregnancytype 2 diabetes preventiondiabetesCare coordinationcare deliverycare fragmentationcommunity health workercommunity partnershipcommunity health aidesfederally qualified health centerunderserved populationpatient education

Outcome Measures

Primary Outcomes (1)

  • Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)

    Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident

    Baseline and upon module completion (approximately 3 months)

Secondary Outcomes (3)

  • Staff - Diabetes Knowledge Test

    Baseline and upon module completion (approximately 3 months)

  • Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))

    Baseline and upon module completion (approximately 3 months)

  • Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)

    Baseline and upon module completion (approximately 3 months)

Other Outcomes (2)

  • Staff-General Self Efficacy Scale (Schwarzer)

    Baseline

  • Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale

    Baseline

Study Arms (1)

Staff - Educational training

EXPERIMENTAL

Nurses, community health workers, and others involved in maternal healthcare

Behavioral: Staff -Educational training

Interventions

Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.

Staff - Educational training

Eligibility Criteria

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

You may qualify if:

  • Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care

You may not qualify if:

  • Clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affinia Healthcare

St Louis, Missouri, 63107, United States

Location

Related Publications (2)

  • Krutilova P, Williams R, Morey R, Field C, Byrth V, Tepe M, McQueen A, Herrick C. Gestational diabetes knowledge improves with interactive online training modules. BMC Med Educ. 2024 Sep 9;24(1):977. doi: 10.1186/s12909-024-05969-z.

  • Krutilova P, Williams R, Morey R, Field C, Byrth V, Tepe M, McQueen A, Herrick C. Gestational diabetes knowledge improves with interactive online training modules: a pre-post analysis. Res Sq [Preprint]. 2023 Jun 2:rs.3.rs-2860961. doi: 10.21203/rs.3.rs-2860961/v1.

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Cynthia Herrick, MD, MPHS
Organization
Washington University In St. Louis School of Medicine

Study Officials

  • Cynthia J Herrick, MD, MPHS

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

July 17, 2020

Study Start

June 18, 2020

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

February 27, 2023

Results First Posted

February 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations