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Elderly Patients With Type 2 Diabetes and Cognitive Exercises

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520995
Acronym
DIACOG
Enrollment
90
Registered
2024-07-25
Start date
2024-04-01
Completion date
2025-03-30
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Diabetes Complications, Diabetes Mellitus, Type 2

Brief summary

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.

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.

Interventions

OTHEREducational 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.

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

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neurocognitive profileThe moment it is included in the study, 3rd month, 6th monthNeurocognitive Assessment Battery

Secondary

MeasureTime frameDescription
Psychological stateThe moment it is included in the study, 3rd month, 6th monthA Scale to assess psychological state
Quality of Life (1)The moment it is included in the study, 3rd month, 6th monthBurden of Diabetes in the Elderly Scale
Hba1cThe moment it is included in the study, 3rd month, 6th monthLaboratory values derived from patients' routine visits
Qality of Life (3)The moment it is included in the study, 3rd month, 6th monthSF-12 Quality of Life Scale
Cognitive Function (2)The moment it is included in the study, 3rd month, 6th monthCognitive Function Instrument-Participant Form
Quality of Life (2)The moment it is included in the study, 3rd month, 6th monthType 2 Diabetes Self-Management Scale

Countries

Turkey (Türkiye)

Contacts

Primary ContactHande Bulut Canbaz, RN,Msc
habulut@ku.edu.tr00905426686310
Backup ContactZeliha Tulek, RN,Prof.Dr.
ztulek@iuc.edu.tr00902122244986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026