A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care

NCT ID: NCT02917226

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.

Conditions

Diabetes Mellitus

Study Groups

Clinical decision support and monitoring system

Group Type: EXPERIMENTAL

Clinical decision support and monitoring system

Intervention Type: OTHER

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical decision support and monitoring system

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being over age 40
• Volunteer
• Computer and Internet literacy
• DM diagnosed or having at least one of diagnostic criteria.

These criteria;

• HbA1c ≥ 6.5
• FPG ≥ 126 mg / dl
• 2-hour postprandial glucose ≥ 200 mg / dl
• Any time postprandial glucose ≥ 200 mg / dl
• Diabetes symptoms

Exclusion Criteria

• Having a communication problem
• Type 1 diabetes
• MODY type DM
• Level of psychiatric disorders in psychosis
• Dementia ones

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Vildan Mevsim

Prof.Dr. Vildan MEVSİM, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vildan Mevsim, Prof., PhD, MD

Role: CONTACT

vildan.mevsim@deu.edu.tr

+905322360044

References

Kart O, Mevsim V, Kut A, Yurek I, Altin AO, Yilmaz O. A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial. BMC Med Inform Decis Mak. 2017 Nov 29;17(1):154. doi: 10.1186/s12911-017-0558-6.

Reference Type: DERIVED

PMID: 29187186 (View on PubMed)

Other Identifiers

2015/23-40

Identifier Type: -

Identifier Source: org_study_id