Clinic to Community Connections - Broader Distribution

Gestational Diabetes Clinical Trial

Official title:

Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474795
• Other study ID #: 202007060
• Secondary ID: 1K23HD096204-01A
• Status: Completed
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: August 22, 2022

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Behavioral:
• Staff -Educational training
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.

Locations

Country	Name	City	State
United States	Affinia Healthcare	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Longer Life Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff-General Self Efficacy Scale (Schwarzer)	General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence	Baseline
Other	Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale	Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation	Baseline
Primary	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	Staff - Diabetes Knowledge Test	Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge	Baseline and upon module completion (approximately 3 months)
Secondary	Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))	Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes	Baseline and upon module completion (approximately 3 months)
Secondary	Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)	Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action	Baseline and upon module completion (approximately 3 months)