Gestational DiabetesNCT04474795
Clinic to Community Connections - Broader Distribution
A study testing Staff -Educational training in people with Gestational Diabetes and Gestational Diabetes Mellitus in Pregnancy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Staff -Educational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2020to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care
Who cannot join
- Clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Staff -Educational training
- 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
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staff -Educational trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Staff - Educational training | Experimental | Nurses, community health workers, and others involved in maternal healthcare Receives: Behavioral: Staff -Educational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and upon module completion (approximately 3 months)
Secondary outcomes (3)
Staff - Diabetes Knowledge Test
Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge
Measured: Baseline and upon module completion (approximately 3 months)
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
Measured: 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
Measured: Baseline and upon module completion (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start18 Jun 2020
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Longer Life Foundation
- Responsible party
- Sponsor
- Investigators
- Cynthia J Herrick, MD, MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474795
- Sponsor's protocol ID
- 202007060
- Other IDs
- 1K23HD096204-01A1
- Status last verified
- Jan 2023
- First submitted
- 18 May 2020
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39251972Krutilova 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.
PubMed 37398401
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04474795
- Acronym / sponsor ID
- 202007060
- Keywords
- diabetes in pregnancy, type 2 diabetes prevention, diabetes, Care coordination, care delivery, care fragmentation, community health worker, community partnership
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Longer Life Foundation
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
| Arm | Type | Receives |
|---|---|---|
| Staff - Educational training | Experimental | Behavioral: Staff -Educational trainingNurses, community health workers, and others involved in maternal healthcare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care
Key exclusion criteria (1 listed)
- Clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staff -Educational trainingNurses 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. | Behavioural | Staff - Educational training |
Primary outcome
Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
Time frame: 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
3 secondary outcomes
Staff - Diabetes Knowledge Test
Time frame: Baseline and upon module completion (approximately 3 months)
Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
Time frame: Baseline and upon module completion (approximately 3 months)
Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
Time frame: Baseline and upon module completion (approximately 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39251972Krutilova 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.
- Derived from this study: PubMed 37398401Krutilova 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.
- Individual participant dataSharing planned: No
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J Herrick, MD, MPHS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staff -Educational training in people with Gestational Diabetes and Gestational Diabetes Mellitus in Pregnancy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed) (time frame: Baseline and upon module completion (approximately 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.