Clinical Trial

Electronic Patient Decision Support System for Patients with Type 2 Diabetes (DiaPaDeSS)

Study acronym: DiaPaDeSS
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Record status
This record was last updated February 6, 2025 (before its estimated July 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study evaluates the effects of an electronic patient decision support system developed for the use of patients with type 2 diabetes (DiaPaDeSS) on self-management, patient activation, and metabolic parameters. To manage type 2 diabetes after discharge, patients must continue to perform interventions at home, such as blood glucose monitoring, blood pressure measurement, weight measurement, medication use, and foot care. To achieve this, patient's self-management and activation levels should be increased. This can also lead to positive improvements in the metabolic parameters. It would be beneficial to develop DiaPaDeSS that can increase the self-management and activation levels of patients with type 2 diabetes. The investigators will develop the DiaPaDeSS intervention protocol. Our content includes patient education information about type 2 diabetes, self-management practice tasks (daily, weekly, quarterly), a type 2 diabetes patient education program according to DiaPaDeSS algorithms, and measurement questionnaires. The content of the DiaPaDeSS will be evaluated by 10 experts in the fields of medicine, nursing, and informatics. A feasibility test with seven patients will be conducted to evaluate the usability of DiaPaDeSS. A single-blind, randomized controlled trial design will be used. Patients with type 2 diabetes will be pretested and randomized (intervention 36, control 36) to the DiaPaDeSS intervention and control groups. Both the DiaPaDeSS intervention and control groups will use the DiaPaDeSS for three months. While participants in the DiaPaDeSS intervention group can reach all contents of the DiaPaDeSS, others can reach only these fields: self-management practice tasks (daily, weekly, quarterly), and measurements questionnaires. The effectiveness of the DiaPaDeSS will be evaluated at baseline and at month 3.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-06-05; most recent amendment 2025-02-04.
Trial Details
NCT Number NCT05902156
Lead Sponsor Akdeniz University
Conditions Mobile Health, Type 2 Diabetes, Patient Activation, Self-Management, Decision Support System, Nursing, Randomized Controlled Trial
Enrollment 72 participants
Start Date 2025-03-30
Primary Completion 2025-07-15 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-06