Elderly Patients With Type 2 Diabetes and Cognitive Exercises
DIACOG
The Effect of Education Program Supported by Cognitive Exercises in Elderly Individuals With Type 2 Diabetes
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 20, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedJuly 25, 2024
July 1, 2024
11 months
July 20, 2024
July 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Neurocognitive profile
Neurocognitive Assessment Battery
The moment it is included in the study, 3rd month, 6th month
Secondary Outcomes (6)
Hba1c
The moment it is included in the study, 3rd month, 6th month
Psychological state
The moment it is included in the study, 3rd month, 6th month
Quality of Life (1)
The moment it is included in the study, 3rd month, 6th month
Quality of Life (2)
The moment it is included in the study, 3rd month, 6th month
Qality of Life (3)
The moment it is included in the study, 3rd month, 6th month
- +1 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONPatients in this group will only receive standard diabetes education.
Video Group
EXPERIMENTALIn 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).
Video and Mobile application Group
EXPERIMENTALIn 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Istanbul, Avcılar, 34320, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, Msc
Study Record Dates
First Submitted
July 20, 2024
First Posted
July 25, 2024
Study Start
April 1, 2024
Primary Completion
February 28, 2025
Study Completion
March 30, 2025
Last Updated
July 25, 2024
Record last verified: 2024-07