Elderly Patients With Type 2 Diabetes and Cognitive Exercises (DIACOG)

July 20, 2024 updated by: Hande Bulut Canbaz, Istanbul University - Cerrahpasa (IUC)

The Effect of Education Program Supported by Cognitive Exercises in Elderly Individuals With Type 2 Diabetes

The study was planned as a single-center, prospective randomized controlled study. Individuals over 65 years of age with type 2 diabetes without severe cognitive impairment will be included in the study. The primary aim of the study is to improve the cognitive functions of the patients after the interventions. The secondary aim is to strengthen patients' diabetes self-management and increase their quality of life, especially by improving their glycemic control. For these purposes, in our study, patients will be randomized into three groups: "cognitive exercise and diabetes education", "diabetes education only" and "control" group. The control group will be provided with standard outpatient diabetes education. Individuals who will be in the "cognitive exercise and video training" group will watch a total of 12 diabetes education videos prepared by the researcher, in which a different topic will be discussed every week for 3 months, and they will also participate cognitive exercises for 15-20 minutes a day for 3 months via a mobile application. Individuals in the "diabetes education only" group will similarly watch a total of 12 diabetes education videos prepared by the researchers. Patients will be evaluated in terms of cognitive function, psychosocial problems (anxiety, depression, stress), glycemic control (HbA1c), diabetes management and quality of life before the interventions, at 3 months and 6 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to strengthen patient outcomes and diabetes management in individuals with diabetes through cognitive-based diabetes education. The study was planned as a single-center, prospective randomized controlled study. İndividuals over 65 years of age with type 2 diabetes with without severe cognitive impairment will be included in the study. In the study, patients will receive diabetes education and cognitive exercise for 12 weeks. In the study, patients will be randomized into three groups: "cognitive exercise and diabetes education", "diabetes education only" and "control" group. The control group will be provided with standard outpatient diabetes education. Patients will be evaluated in terms of cognitive function, psychosocial problems (anxiety, depression, stress), glycemic control (HbA1c), diabetes management and quality of life before the interventions, at 3 months and 6 months.

In the study, diabetes education will be provided through short, understandable diabetes education videos prepared by the researcher with up-to-date guide information. A total of 12 videos will be sent to patients' phones, covering a different topic each week for 3 months. Diabetes education video contents are as follows; Type 2 diabetes definition, symptoms and the effect of diabetes on cognitive functions, Medical nutrition therapy and healthy nutrition recommendations in Type 2 diabetes, The importance of diabetes and exercise, Oral antidiabetic treatments, Insulin treatment, Hypoglycemia symptoms, findings and treatment, Macrovascular complications in diabetes, Microvascular complications in diabetes, Foot Protection and care recommendations, Diabetes self-care skills and problem-solving strategies, Diabetes and stress management.

A mobile application will be used as a cognitive exercise tool in the study. This mobile application is a science-based application that patients can access via their smartphone or tablet. It consists of verbal, numerical, visual, logical, memory and attention categories and contains 24 different gamified mind exercises.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hande Bulut Canbaz, RN,Msc
  • Phone Number: 00905426686310
  • Email: habulut@ku.edu.tr

Study Contact Backup

  • Name: Zeliha Tulek, RN,Prof.Dr.
  • Phone Number: 27254 00902122244986
  • Email: ztulek@iuc.edu.tr

Study Locations

  • Turkey
    • Avcılar
      • Istanbul, Avcılar, Turkey, 34320
        • Recruiting
        • Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hande Bulut Canbaz, Msc
        • Sub-Investigator:
          • Zeliha Tulek, Prof.Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least one year
  • Literate
  • Able to use smartphone/tablet/computer and have internet access
  • Individuals who agree to participate in the study will be included.

Exclusion Criteria:

  • Type 1 diabetes
  • With severe cognitive impairment
  • Known neurological or psychiatric disorders
  • Severely depressed
  • Individuals with disabilities (vision, hearing problems, etc.) will not be included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients in this group will only receive standard diabetes education.
Experimental: Video Group
In addition to standard diabetes education, patients in this group will be educated with the mentioned video education program (a total of 12 diabetes education videos prepared by the researcher).
Other: Educational video program
Diabetes education video contents are as follows; Type 2 diabetes definition, symptoms and the effect of diabetes on cognitive functions, Medical nutrition therapy and healthy nutrition recommendations in Type 2 diabetes, The importance of diabetes and exercise, Oral antidiabetic treatments, Insulin treatment, Hypoglycemia symptoms, findings and treatment, Macrovascular complications in diabetes, Microvascular complications in diabetes, Foot Protection and care recommendations, Diabetes self-care skills and problem-solving strategies, Diabetes and stress management.
Experimental: Video and Mobile application Group
In addition to standard diabetes education and video education, patients in this group will participate in cognitive exercises for 15-20 minutes a day for 3 months via a mobile application.
Other: Educational video program
Diabetes education video contents are as follows; Type 2 diabetes definition, symptoms and the effect of diabetes on cognitive functions, Medical nutrition therapy and healthy nutrition recommendations in Type 2 diabetes, The importance of diabetes and exercise, Oral antidiabetic treatments, Insulin treatment, Hypoglycemia symptoms, findings and treatment, Macrovascular complications in diabetes, Microvascular complications in diabetes, Foot Protection and care recommendations, Diabetes self-care skills and problem-solving strategies, Diabetes and stress management.
Other: A mobile application
This mobile application is a science-based application that patients can access via their smartphone or tablet. It consists of verbal, numerical, visual, logical, memory and attention categories and contains 24 different gamified mind exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive profile
Time Frame: The moment it is included in the study, 3rd month, 6th month
Neurocognitive Assessment Battery
The moment it is included in the study, 3rd month, 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hba1c
Time Frame: The moment it is included in the study, 3rd month, 6th month
Laboratory values derived from patients' routine visits
The moment it is included in the study, 3rd month, 6th month
Psychological state
Time Frame: The moment it is included in the study, 3rd month, 6th month
A Scale to assess psychological state
The moment it is included in the study, 3rd month, 6th month
Quality of Life (1)
Time Frame: The moment it is included in the study, 3rd month, 6th month
Burden of Diabetes in the Elderly Scale
The moment it is included in the study, 3rd month, 6th month
Quality of Life (2)
Time Frame: The moment it is included in the study, 3rd month, 6th month
Type 2 Diabetes Self-Management Scale
The moment it is included in the study, 3rd month, 6th month
Qality of Life (3)
Time Frame: The moment it is included in the study, 3rd month, 6th month
SF-12 Quality of Life Scale
The moment it is included in the study, 3rd month, 6th month
Cognitive Function (2)
Time Frame: The moment it is included in the study, 3rd month, 6th month
Cognitive Function Instrument-Participant Form
The moment it is included in the study, 3rd month, 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Zeliha Tulek, RN,Prof. Dr., Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
  • Principal Investigator: Hande Bulut Canbaz, RN,Msc, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

July 20, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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