Clinical trial NCT06520995: Elderly Patients With Type 2 Diabetes and Cognitive Exercises
Official title: The Effect of Education Program Supported by Cognitive Exercises in Elderly Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Diabetes Mellitus, Type 2
Diabetes Complications
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive profile
timeFrame: The moment it is included in the study, 3rd month, 6th month
Secondary outcomes:
measure: Hba1c
timeFrame: The moment it is included in the study, 3rd month, 6th month
measure: Psychological state
timeFrame: The moment it is included in the study, 3rd month, 6th month
measure: Quality of Life (1)
timeFrame: The moment it is included in the study, 3rd month, 6th month
measure: Quality of Life (2)
timeFrame: The moment it is included in the study, 3rd month, 6th month
measure: Qality of Life (3)
timeFrame: The moment it is included in the study, 3rd month, 6th month
measure: Cognitive Function (2)
timeFrame: The moment it is included in the study, 3rd month, 6th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
state: Avcılar
Study officials:
affiliation: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
name: Zeliha Tulek, RN,Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
name: Hande Bulut Canbaz, RN,Msc
role: PRINCIPAL_INVESTIGATOR
References: