Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
Conditions
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
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.
Interventions
BEHAVIORALStaff -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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Longer Life Foundation
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed) | Baseline and upon module completion (approximately 3 months) | Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff - Diabetes Knowledge Test | Baseline and upon module completion (approximately 3 months) | 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)) | Baseline and upon module completion (approximately 3 months) | 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) | Baseline and upon module completion (approximately 3 months) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Staff-General Self Efficacy Scale (Schwarzer) | Baseline | 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 |
| Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale | Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Staff - Educational Training Nurses, community health workers, and others involved in maternal healthcare
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. | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Staff - Educational Training |
|---|---|
| Age, Continuous | 37.0 years |
| Diabetes Attitudes Scale Need for special training | 4.80 units on a scale |
| Diabetes Attitudes Scale Patient autonomy | 4.25 units on a scale |
| Diabetes Attitudes Scale Value of tight control | 4.14 units on a scale |
| Education/Training CHW or MA | 18 Participants |
| Education/Training Nurses (RN/LPN/CHN), CDCES, or RD | 46 Participants |
| Education/Training Other | 18 Participants |
| GDM knowledge score Module 1 Score | 60.0 units on a scale |
| GDM knowledge score Module 2 Score | 66.7 units on a scale |
| GDM knowledge score Module 3 Score | 57.1 units on a scale |
| GDM knowledge score Module 4 Score | 40.0 units on a scale |
| GDM knowledge score Overall Score | 56.5 units on a scale |
| Intention to Recommend Diabetes Prevention Measures | 4.63 units on a scale |
| Race/Ethnicity, Customized Black or African American, non-Hispanic | 14 Participants |
| Race/Ethnicity, Customized Latinx or Hispanic | 8 Participants |
| Race/Ethnicity, Customized Native American, Asian, another race | 7 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 53 Participants |
| Region of Enrollment United States | 82 participants |
| Self-Efficacy to Provide Diabetes Education Scale | 7.00 units on a scale |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 1 Participants |
| Specialty Internal Medicine/Family Medicine | 7 Participants |
| Specialty Ob-Gyn/Maternal -Child Health | 52 Participants |
| Specialty Other | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
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
Time frame: Baseline and upon module completion (approximately 3 months)
Population: Population who completed pre and post training assessments and accessed all 4 training modules
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Staff - Educational Training | Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed) | Pre-training Score (Baseline) | 6.60 units on a scale |
| Staff - Educational Training | Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed) | Post-training Score (Module Completion) | 9.33 units on a scale |
Comparison: Compared pre and post training scoresp-value: <0.0001Wilcoxon paired signed rank test
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
Time frame: Baseline and upon module completion (approximately 3 months)
Population: Pre and post training scores in individuals who completed training modules
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Pre-training score (Patient Autonomy) | 4.44 units on a scale |
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Post-training score (Patient Autonomy) | 4.38 units on a scale |
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Pre-training score (value of tight control) | 4.07 units on a scale |
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Post-training score (value of tight control) | 4.43 units on a scale |
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Pre-training score (need for special training) | 5.00 units on a scale |
| Staff - Educational Training | Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) | Post-training score (need for special training) | 5.00 units on a scale |
Comparison: Patient autonomyp-value: 0.606Wilcoxon paired signed rank test
Comparison: Value of tight controlp-value: 0.003Wilcoxon paired signed rank test
Comparison: Need for Special Trainingp-value: 0.475Wilcoxon paired signed rank test
Secondary
Staff - Diabetes Knowledge Test
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)
Population: Individuals who completed pre and post-test assessments and accessed all 4 training modules
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Staff - Educational Training | Staff - Diabetes Knowledge Test | Pre-training score (Baseline) | 56.5 units on a scale |
| Staff - Educational Training | Staff - Diabetes Knowledge Test | Post-training score (Module completion) | 78.3 units on a scale |
Comparison: Comparison of scores pre and post training in individuals who completed training modulesp-value: <0.0001Wilcoxon paired signed rank test
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
Time frame: Baseline and upon module completion (approximately 3 months)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Staff - Educational Training | Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed) | Pre-training score | 4.81 units on a scale |
| Staff - Educational Training | Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed) | Post-training score | 5.00 units on a scale |
p-value: 0.009Wilcoxon paired signed rank test
Other Pre-specified
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
Time frame: Baseline
Other Pre-specified
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
Time frame: Baseline