跳至主要内容
临床试验/NCT06520995
NCT06520995招募中不适用

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

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Neurocognitive profile

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Control Group

No Intervention

Patients in this group will only receive standard diabetes education.

Video Group

Experimental

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).

干预措施: Educational video program (Other)

Video and Mobile application Group

Experimental

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.

干预措施: Educational video program (Other)

Video and Mobile application Group

Experimental

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.

干预措施: A mobile application (Other)

结局指标

主要结局

Neurocognitive profile

时间窗: The moment it is included in the study, 3rd month, 6th month

Neurocognitive Assessment Battery

次要结局

  • Psychological state(The moment it is included in the study, 3rd month, 6th month)
  • Cognitive Function (2)(The moment it is included in the study, 3rd month, 6th month)
  • Hba1c(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)
  • Qality of Life (3)(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)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hande Bulut Canbaz

RN, Msc

Istanbul University - Cerrahpasa

研究点 (1)

Loading locations...

相似试验