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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD096204-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Longer Life Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staff - Educational training | Experimental | Nurses, community health workers, and others involved in maternal healthcare |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staff -Educational training | Behavioral | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3)) |
| 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 |
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
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia J Herrick, MD, MPHS | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affinia Healthcare | St Louis | Missouri | 63107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39251972 | Derived | 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. | |
| 37398401 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population of individuals who completed at least 50% of one of the measures on the baseline survey
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Population who completed pre and post training assessments and accessed all 4 training modules | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and upon module completion (approximately 3 months) |
|
Individuals were not assigned to an intervention that was anticipated to result in adverse events. Individuals had the opportunity to contact the study team with questions or concerns at any time over the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Herrick, MD, MPHS | Washington University In St. Louis School of Medicine | 3147470278 | herrickc@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2022 | Jan 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
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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 - 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) |
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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education/Training | Count of Participants | Participants |
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| Specialty | Count of Participants | Participants |
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| GDM knowledge score | Median | Inter-Quartile Range | units on a scale |
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| Self-Efficacy to Provide Diabetes Education Scale | Median | Inter-Quartile Range | units on a scale |
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| Diabetes Attitudes Scale | Median | Inter-Quartile Range | units on a scale |
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| Intention to Recommend Diabetes Prevention Measures | Median | Inter-Quartile Range | units on a scale |
|
|
|
|
| Secondary | Staff - Diabetes Knowledge Test | Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge | Individuals who completed pre and post-test assessments and accessed all 4 training modules | Posted | Median | Inter-Quartile Range | units on a scale | 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 | Pre and post training scores in individuals who completed training modules | Posted | Median | Inter-Quartile Range | units on a scale | 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 | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and upon module completion (approximately 3 months) |
|
|
|
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| 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 | Not Posted | Baseline | Participants |
| 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 | Not Posted | Baseline | Participants |
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Post-training score (value of tight control) |
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| Pre-training score (need for special training) |
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| Post-training score (need for special training) |
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| 0.003 |
| Superiority |
| Need for Special Training | Wilcoxon paired signed rank test | 0.475 | Superiority |