Clinic to Community Connections - Broader Distribution

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Behavioral: Staff -Educational training

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia J Herrick, MD, MPHS; Phone Number: 314-747-0278; Email: herrickc@wustl.edu
• Study Contact Backup: Name: Roxann C Williams, MPH; Phone Number: 314-362-5404; Email: rcrenshaw@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63107
      • Affinia Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Staff - Educational training; Nurses, community health workers, and others involved in maternal healthcare

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Longer Life Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; patient education; community health worker; diabetes in pregnancy; Care coordination; type 2 diabetes prevention; care delivery; underserved population; care fragmentation; community partnership; community health aides; federally qualified health center
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 202007060; 1K23HD096204-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No