Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229110
Other study ID # 13-039/C
Secondary ID
Status Completed
Phase N/A
First received August 27, 2014
Last updated June 15, 2015
Start date October 2013
Est. completion date March 2015

Study information

Verified date June 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

Patients with type 2 diabetes mellitus can receive care in the general practice or at the outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and the hospital are connected through Diamuraal to organize the diabetes care in that region. They work in the same electronic medical record, and patients can request access to their own record (called a patient web portal). They set up Diamuraal guidelines, based on the guidelines of the Dutch College of General Practitioners and Internists, on where the patient care needs to be allocated (primary or secondary care), depending on the amount of specific care a patient needs. Despite guidelines, not all patients are treated in the correct place.

Our hypotheses is that when we improve triage we can cause a major shift from treatment in secondary care to primary care and from primary care to self-care by using the patient web portal. Furthermore, patients who needs extra attention due to problems with their diabetes or complications can receive this extra attention due to increased e-consultation between primary care and secondary care and if necessary actually can, during a short time, be treated by an internist. We hope to achieve this by introducing a signal in the electronic medical record. This signal allocates patients according to the guidelines and warns a physician if their patients is not treated according to that guideline. The health care provider can then discuss this situation with his patient. We believe that this leads to shift in allocation of care, in which optimal care is provided and patients are made more aware of their situation which hopefully leads to better self-management and satisfaction.


Recruitment information / eligibility

Status Completed
Enrollment 2779
Est. completion date March 2015
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with type 2 diabetes mellitus

- health care provider work within Diamuraal setting

Exclusion Criteria:

- none

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Signal
Automatic signal in the electronic medical record

Locations

Country Name City State
Netherlands Diamuraal-associated GP practices Amersfoort
Netherlands Meander Medical Center Amersfoort

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Ronda MC, Dijkhorst-Oei LT, Gorter KJ, Beulens JW, Rutten GE. Differences between diabetes patients who are interested or not in the use of a patient Web portal. Diabetes Technol Ther. 2013 Jul;15(7):556-63. doi: 10.1089/dia.2013.0023. Epub 2013 Jun 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with change in allocation of care after intervention One of the following:
shift from primary care to secondary care
shift from secondary care to primary care
continuation of treatment in primary care but with addition of e-consultation with secondary care
continuation of treatment in primary care but with replacement of one or more office visits in self-control
One year No
Secondary Assembly of reasons by health care providers for not following the guidelines One year No
Secondary Change in quality of diabetes care Measured with Quality of Care and Outcomes in Type 2 Diabetes scoring system (QuED) containing scores for biomedical data (HbA1c, blood pressure, lipids, medication regimen, number of measurements) One year No
Secondary Change in diabetes treatment satisfaction Measured with the diabetes treatment satisfaction questionnaire (DTSQ): six questions on satisfaction with treatment regimen and two questions on perceived frequency of hyperglycemia and hypoglycemia. One year No
Secondary Number of participants who meet their treatment goals Measured in number of goals that are met One year No
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A

External Links