Back to resultsClinic to Community Connections - Broader Distribution
Primary Purpose
Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Staff -Educational training
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring diabetes in pregnancy, type 2 diabetes prevention, diabetes, Care coordination, care delivery, care fragmentation, community health worker, community partnership, community health aides, federally qualified health center, underserved population, patient education
Eligibility Criteria
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
Sites / Locations
- Affinia Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Staff - Educational training
Arm Description
Nurses, community health workers, and others involved in maternal healthcare
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Staff - Diabetes Knowledge Test
Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge
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
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
Full Information
NCT ID
NCT04474795
First Posted
May 18, 2020
Last Updated
January 30, 2023
Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Longer Life Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04474795
Brief Title
Clinic to Community Connections - Broader Distribution
Official Title
Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Longer Life Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
Keywords
diabetes in pregnancy, type 2 diabetes prevention, diabetes, Care coordination, care delivery, care fragmentation, community health worker, community partnership, community health aides, federally qualified health center, underserved population, patient education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staff - Educational training
Arm Type
Experimental
Arm Description
Nurses, community health workers, and others involved in maternal healthcare
Intervention Type
Behavioral
Intervention Name(s)
Staff -Educational training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
Description
Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident
Time Frame
Baseline and upon module completion (approximately 3 months)
Secondary Outcome Measure Information:
Title
Staff - Diabetes Knowledge Test
Description
Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge
Time Frame
Baseline and upon module completion (approximately 3 months)
Title
Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Description
Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes
Time Frame
Baseline and upon module completion (approximately 3 months)
Title
Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
Description
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
Time Frame
Baseline and upon module completion (approximately 3 months)
Other Pre-specified Outcome Measures:
Title
Staff-General Self Efficacy Scale (Schwarzer)
Description
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
Time Frame
Baseline
Title
Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale
Description
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
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J Herrick, MD, MPHS
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affinia Healthcare
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinic to Community Connections - Broader Distribution
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