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

NCT05902156 | Not Yet Recruiting DMC

• 1 other identifier: KAEK-125
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mobile Health; Type 2 Diabetes; Patient Activation; Self-Management; Decision Support System; Nursing; Randomized Controlled Trial

Keywords

Mobile Health; Type 2 Diabetes; Patient Activation; Decision Support System; Self-Management; Nursing; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

Study Arms (2)

DiaPaDeSS intervention group

EXPERIMENTAL

DiaPaDeSS will be introduced to participants with type 2 diabetes during face-to-face interviews. The DiaPaDeSS intervention group will have access to all the contents of the DiaPaDeSS, which includes 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. During the follow-up period, the participants in the DiaPaDeSS intervention group will take DiaPaDeSS messages once a week and be reminded to use the education program. The DiaPaDeSS will be asked to use it for three months on daily and weekly inputs. During the follow-up period, the participants can contact the researcher via 24/7 on the DiaPaDeSS. Participants in the DiaPaDeSS intervention group will also receive routine patient education and hospital follow-ups.

Behavioral: DiaPaDeSS

Control Group

ACTIVE COMPARATOR

DiaPaDeSS will be introduced to participants with type 2 diabetes in the control group during face-to-face interviews. The control group will have access to only these fields 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. Participants in the DiaPaDeSS group will also receive routine patient education and routine hospital follow-up during the three-month follow-up period..

Behavioral: DiaPaDeSS

Interventions

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 intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Who are literate
• Who have internet access at home, who have one of the tools such as a computer, tablet or smartphone and can use these tools
• Consented to participate in the study
• Had no other psychiatric or mental barriers to answering the questions, language or cognitive difficulties, and barriers to verbal or written communication

You may not qualify if:

• 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
• Had pregnant
• Having dementia and cognitive deficits
• Having retinopathy or advanced neuropathy
• Patients whose information is not allowed to be accessed

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Participation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Merve YUKSEL, MSc

CONTACT

+90 507 770 01 47; merveyuksel@akdeniz.edu.tr

Hicran BEKTAS, Ph.D., RN

CONTACT

+90 242 3106116; hbaydin@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be divided into groups according to the randomization list created to assign each patient to a group. Two independent researchers will assign participants to the DiaPaDeSS intervention and control groups and evaluate the outcome measurement data. Researchers will not be blinded because they will perform these interventions. However, the participants will be blinded because they do not know which group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: March 30, 2025
• Primary Completion: July 15, 2025
• Study Completion: November 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

TU (1)