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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAkdeniz University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with type 2 diabetes who had been followed up and treated at the Endocrinology and Metabolic Diseases Polyclinic

Aged between 18-65 years

Patients who know their diagnosis and can verbally express it

Have been diagnosed with type 2 diabetes for at least six months

Disqualifiers

Diagnosed with myocardial infarction, stroke or diabetic foot in the last six months

Diagnosed with type 1 diabetes or gestational diabetes

Diagnosed with terminal illness

Using steroid therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • DiaPaDeSS

    Behavioral

    Web-based mobile health application for patients with type 2 diabetes (the patient education information about type 2 diabetes, self-management practice tasks (daily, weekly, quarterly), type 2 diabetes patient education program according to DiaPaDeSS algorithms, and measurement questionnaires)

  • DiaPaDeSS

    Behavioral

    Web-based mobile health application for patients with type 2 diabetes (only self-management practice tasks (daily, weekly, quarterly), and measurements questionnaires. The diabetes patient education brochure of the Ministry of Health will be sent to the phones of the active control group in pdf format.)

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: DiaPaDeSS intervention groupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Type 2 Diabetes Self-Management Scale

The Type 2 Diabetes Self-Management Scale was developed to evaluate the self-management of patients with type 2 diabetes. The scale consists of a total of 19 items and three sub-dimensions. These dimensions were determined as the "Healthy Lifestyle Behaviors" dimension consisting of 11 questions, the "Health Services Use" dimension consisting of four questions, and the "Blood Sugar Management" dimension consisting of four questions. Scoring of the scale; "always 5 points", "often 4 points", "sometimes 3 points", "rarely 2 points", "never 1 point". High scores on the scale indicate good self-management, and low scores indicate poor self-management. The Cronbach's alpha value of the scale was determined as 0.85.

Time frame
12 weeks
2

Patient Activation Measure (PAM)

The Patient Activation Measure (PAM) gauges a patient's level of belief, knowledge, skills, and self-assurance. Thirteen components comprise the Patient Activation Measure. Patients are actively/successfully managing their disease when they receive higher scores on the scale. Each response option has a 4-point Likert scale with the options ranging from totally disagree to totally agree and 'non applicable.' Scores for activities range from 0 to 100. Level 1, the lowest activity with a score of 47, deals with the idea that playing an active part is important. Level 2, which ranges from 47 to 55, denotes knowledge and the capacity for action. Level 3, which ranges from 55 to 72, deals with action. The highest activity, Level 4, with scores of \>72.5, is keeping to a Schedule even when under stress. Cronbach's alpha value of the original scale was determined as 0.88.

Time frame
12 weeks
3

The Metabolic Parameter Monitoring Form

The Metabolic Parameter Monitoring Form was created by researchers in line with the literature to evaluate results that may affect the prognosis of type 2 diabetes during the application process. It was created to evaluate the changes in the basic parameters: (a) HbA1c (mmol/L), (b) blood glucose (mg/dL), (c) blood pressure (mmHg), (d) cholesterol (mg/dL), (e) triglyceride (mg/dL) values, (f) body mass index ((weight and height will be combined to report BMI in kg/m2) that should be evaluated in patients with type 2 diabetes. In the first meeting, it is planned to obtain the laboratory results of the patients from the electronic patient records with the permission of the diabetes nurses in the Endocrinology and Metabolic Diseases Polyclinic and to compare them with the laboratory results last examined at the end of the third month. Average value will be calculated for levels taken in the first and last month.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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