Trial Outcomes & Findings for Clinic to Community Connections - Broader Distribution (NCT NCT04474795)
NCT ID: NCT04474795
Last Updated: 2023-02-27
Results Overview
Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Baseline and upon module completion (approximately 3 months)
Results posted on
2023-02-27
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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85
|
|
Overall Study
Completed Pre-test
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82
|
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Overall Study
Accessed Training Module 1
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65
|
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Overall Study
Accessed Training Module 2
|
45
|
|
Overall Study
Accessed Training Module 3
|
41
|
|
Overall Study
Accessed Training Module 4
|
20
|
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Overall Study
COMPLETED
|
20
|
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Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinic to Community Connections - Broader Distribution
Baseline characteristics by cohort
| Measure |
Staff - Educational Training
n=82 Participants
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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|---|---|
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Age, Continuous
|
37.0 years
n=93 Participants
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|
Sex: Female, Male
Female
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81 Participants
n=93 Participants
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Sex: Female, Male
Male
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1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American, non-Hispanic
|
14 Participants
n=93 Participants
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Race/Ethnicity, Customized
Latinx or Hispanic
|
8 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native American, Asian, another race
|
7 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
53 Participants
n=93 Participants
|
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Region of Enrollment
United States
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82 participants
n=93 Participants
|
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Education/Training
Nurses (RN/LPN/CHN), CDCES, or RD
|
46 Participants
n=93 Participants
|
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Education/Training
CHW or MA
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18 Participants
n=93 Participants
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Education/Training
Other
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18 Participants
n=93 Participants
|
|
Specialty
Internal Medicine/Family Medicine
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7 Participants
n=93 Participants
|
|
Specialty
Ob-Gyn/Maternal -Child Health
|
52 Participants
n=93 Participants
|
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Specialty
Other
|
23 Participants
n=93 Participants
|
|
GDM knowledge score
Overall Score
|
56.5 units on a scale
n=93 Participants
|
|
GDM knowledge score
Module 1 Score
|
60.0 units on a scale
n=93 Participants
|
|
GDM knowledge score
Module 2 Score
|
66.7 units on a scale
n=93 Participants
|
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GDM knowledge score
Module 3 Score
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57.1 units on a scale
n=93 Participants
|
|
GDM knowledge score
Module 4 Score
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40.0 units on a scale
n=93 Participants
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Self-Efficacy to Provide Diabetes Education Scale
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7.00 units on a scale
n=93 Participants
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Diabetes Attitudes Scale
Patient autonomy
|
4.25 units on a scale
n=93 Participants
|
|
Diabetes Attitudes Scale
Value of tight control
|
4.14 units on a scale
n=93 Participants
|
|
Diabetes Attitudes Scale
Need for special training
|
4.80 units on a scale
n=93 Participants
|
|
Intention to Recommend Diabetes Prevention Measures
|
4.63 units on a scale
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline and upon module completion (approximately 3 months)Population: Population who completed pre and post training assessments and accessed all 4 training modules
Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident
Outcome measures
| Measure |
Staff - Educational Training
n=20 Participants
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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|---|---|
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Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
Pre-training Score (Baseline)
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6.60 units on a scale
Interval 4.93 to 7.66
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Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
Post-training Score (Module Completion)
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9.33 units on a scale
Interval 9.0 to 9.87
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SECONDARY outcome
Timeframe: Baseline and upon module completion (approximately 3 months)Population: Individuals who completed pre and post-test assessments and accessed all 4 training modules
Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge
Outcome measures
| Measure |
Staff - Educational Training
n=20 Participants
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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|---|---|
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Staff - Diabetes Knowledge Test
Pre-training score (Baseline)
|
56.5 units on a scale
Interval 48.9 to 65.2
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Staff - Diabetes Knowledge Test
Post-training score (Module completion)
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78.3 units on a scale
Interval 65.2 to 87.0
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SECONDARY outcome
Timeframe: Baseline and upon module completion (approximately 3 months)Population: Pre and post training scores in individuals who completed training modules
Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes
Outcome measures
| Measure |
Staff - Educational Training
n=20 Participants
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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|---|---|
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Pre-training score (Patient Autonomy)
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4.44 units on a scale
Interval 3.75 to 4.59
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Post-training score (Patient Autonomy)
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4.38 units on a scale
Interval 3.91 to 4.63
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Pre-training score (value of tight control)
|
4.07 units on a scale
Interval 3.75 to 4.54
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Post-training score (value of tight control)
|
4.43 units on a scale
Interval 4.0 to 4.86
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Pre-training score (need for special training)
|
5.00 units on a scale
Interval 4.6 to 5.0
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Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Post-training score (need for special training)
|
5.00 units on a scale
Interval 4.65 to 5.0
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SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Staff - Educational Training
n=20 Participants
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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|---|---|
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Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
Pre-training score
|
4.81 units on a scale
Interval 4.37 to 5.0
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Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
Post-training score
|
5.00 units on a scale
Interval 5.0 to 5.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineGeneral 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMeasure 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
Outcome measures
Outcome data not reported
Adverse Events
Staff - Educational Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cynthia Herrick, MD, MPHS
Washington University In St. Louis School of Medicine
Phone: 3147470278
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place