- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268081
Specialist Conferences Between General Practitioners and Endocrinologists (STAR)
Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall aim is to study if cross-sectoral and virtual specialist conferences improves diabetes care and increases diabetes competencies and management in general practice. The expectation is that the intervention will:
at the patient level:
- improve adherence to international recommendations on diabetes medication for patients with Type 2-diabetes (T2D)
- improve the risk profile of patients with T2D with a reduction in glycated haemoglobin, blood pressure and cholesterol
at the general practice level:
- improve the self-reported competence and confidence in management of patients with T2D among general practitioners and practice staff
The intervention consists of four virtual and thematic conferences: (1) T2D and cardiovascular disease and heart failure, (2) T2D and lipids, (3) T2D and kidney disease and blood pressure, and (4) T2D and a free topic selected by the general practitioner (GP). Before having the first virtual conference, an introductory webinar is held to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to an endocrinologist who they meet at all four conferences. The intervention was developed using the Medical Research Framework for developing complex interventions.
All general practices located in the Municipality of Aarhus, Denmark are invited (n = 100). Block randomization is performed at the general practice level, and general practices will be randomized in a 1:1 ratio to either the intervention or the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Danmark
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Aarhus N, Danmark, Denmark, 8200
- Steno Diabetes Center Aarhus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- General practices are eligible for inclusion if licensed and located in the municipality of Aarhus.
- GPs must consent to participate in the intervention and collect the data needed to measure patient and general practice outcomes.
- GPs must agree to bring patient cases to the virtual conferences who are ≥18 years, diagnosed with T2D and who they would like to discuss with the endocrinologist.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual specialist conferences
The group of general practices who participates in the virtual specialist conferences with endocrinologists.
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The intervention consists of four virtual conferences (45 min each in month 2, 5, 8 and 11) and an introductory webinar (90 min in month 1) to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D.
Each general practice is assigned to one specific endocrinologist they meet with throughout.
The four virtual conferences are thematic: T2D and cardiovascular disease and heart failure, T2D and lipids, T2D and kidney disease and blood pressure, and T2D and a free topic selected by the GP.
At each conference, the GP must bring 2-3 patient cases related to the theme and 1-2 patients of their own choice.
The GP chairs the meeting.
Each conference follows the same format: Check in (5 min); Short presentation by the endocrinologist (10 min); Presentation by GP and joint dialogue about theme-related patients (20 min); Presentation by GP and joint dialogue about theme-unrelated patients (optional, 5 min); (5) Wrapping-up (5 min).
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No Intervention: Standard of care
Receives the usual, standard practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Time Frame: Month 12
|
Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor
|
Month 12
|
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Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Time Frame: Month 12
|
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
|
Month 12
|
|
LDL>2.5 mmol/L treated with Statins
Time Frame: Month 12
|
Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins
|
Month 12
|
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Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
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|
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
|
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Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
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Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
|
|
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
|
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Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol
Time Frame: Month 12
|
Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Time Frame: Month 24
|
Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor
|
Month 24
|
|
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Time Frame: Month 24
|
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
|
Month 24
|
|
LDL>2.5 mmol/L treated with Statins
Time Frame: Month 24
|
Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins
|
Month 24
|
|
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
|
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
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Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
|
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
|
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
|
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month
Time Frame: Month 24
|
Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 24
|
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Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months
Time Frame: Month 12 and Month 24
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Percentage of patients with type 2-diabetes and HbA1c <58 mmol/L
|
Month 12 and Month 24
|
|
Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Percentage of patients with type 2-diabetes and HbA1c <53 mmol/L
|
Month 12 and Month 24
|
|
Patients with T2D and blood pressure <140 mmHg at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Percentage of patients with type 2-diabetes and blood pressure <140 mmHg
|
Month 12 and Month 24
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|
Patients with T2D and blood pressure <130 mmHg at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Percentage of patients with type 2-diabetes and blood pressure <130 mmHg
|
Month 12 and Month 24
|
|
Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Percentage of patients with type 2-diabetes and low-density lipoprotein >2.5 mmol/L
|
Month 12 and Month 24
|
|
Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Percentage of patients with type 2-diabetes and microalbuminuria and LDL >1.8 mmol/L
|
Month 12 and Month 24
|
|
Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the general practitioner about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect. Range 1-5, higher score indicates relational coordination. |
Month 12 and Month 24
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Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the general practitioner about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect. Range 1-5, higher score indicates relational coordination. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the general practitioner about using virtual conferences measured along the four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences. Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings. |
Month 12 and Month 24
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Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the practice staff about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect. Range 1-5, higher score indicates higher relational coordination. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the practice staff about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect. Range 1-5, higher score indicates higher relational coordination. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported assessment by the practice staff about using virtual conferences measured along four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences. Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month
Time Frame: Month 12 and Month 24
|
Self-reported degree to which the practice staff is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant; achieving high treatment quality for patients with diabetes. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month
Time Frame: Month 12 and Month 24
|
Self-reported degree to which the practice staff is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; achieving high treatment quality for patients with diabetes and heart failure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported degree to which the practice staff is confident in: managing high blood pressure in patients with diabetes; achieving high treatment quality for patients with diabetes and high blood pressure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months
Time Frame: Month 12 and Month 24
|
Self-reported degree to which the practice staff is confident in: managing kidney disease in patients with diabetes; achieving high treatment quality for patients with diabetes and kidney disease. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12 and Month 24
|
|
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month
Time Frame: Month 12 and Month 24
|
Self-reported degree to which the practice staff is confident in managing high cholesterol in patients with diabetes. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence. |
Month 12 and Month 24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thim Prætorius, PhD, Aarhus University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-30-72-353-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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