Cognitive ImpairmentDIACOGNCT06520995
Elderly Patients With Type 2 Diabetes and Cognitive Exercises
A study testing Educational video program and A mobile application in people with Cognitive Impairment and Diabetes Mellitus, Type 2, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- Educational video program and A mobile application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Istanbul, Avcılar, 34320
Hande Bulut Canbaz, MSc, 00905426686310, habulut@ku.edu.tr
Zeliha Tulek, Prof.Dr., 902122244986 ext. 27254, ztulek@iuc.edu.tr
About this study
Official title: 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.
Read the 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.
- Being tested
- Educational video program, A mobile application
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational video programOther
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 applicationOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Educational video program |
| 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. Receives: Other: Educational video program; Other: A mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive profile
Neurocognitive Assessment Battery
Measured: The moment it is included in the study, 3rd month, 6th month
Secondary outcomes (6)
Hba1c
Laboratory values derived from patients' routine visits
Measured: The moment it is included in the study, 3rd month, 6th month
Psychological state
A Scale to assess psychological state
Measured: The moment it is included in the study, 3rd month, 6th month
Quality of Life (1)
Burden of Diabetes in the Elderly Scale
Measured: The moment it is included in the study, 3rd month, 6th month
Quality of Life (2)
Type 2 Diabetes Self-Management Scale
Measured: The moment it is included in the study, 3rd month, 6th month
Qality of Life (3)
SF-12 Quality of Life Scale
Measured: The moment it is included in the study, 3rd month, 6th month
Cognitive Function (2)
Cognitive Function Instrument-Participant Form
Measured: The moment it is included in the study, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Apr 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Bulut Canbaz, Istanbul University - Cerrahpasa
- Investigators
- Zeliha Tulek, RN,Prof. Dr., Study director, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of NursingHande Bulut Canbaz, RN,Msc, Principal investigator, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520995
- Sponsor's protocol ID
- 2023/183
- Acronym
- DIACOG
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Program Supported by Cognitive Exercises in Elderly Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06520995
- Acronym / sponsor ID
- DIACOG / 2023/183
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in this group will only receive standard diabetes education. |
| Video Group | Experimental | Other: Educational video programIn 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 | Experimental | Other: Educational video program, Other: A mobile applicationIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational video programDiabetes 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 | Video Group, Video and Mobile application Group |
| A mobile applicationThis 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 | Other | Video and Mobile application Group |
Primary outcome
Neurocognitive profile
Time frame: The moment it is included in the study, 3rd month, 6th month
Neurocognitive Assessment Battery
6 secondary outcomes
Hba1c
Time frame: 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
Quality of Life (1)
Time frame: 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
Qality of Life (3)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Tulek, RN,Prof. Dr. study director
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Hande Bulut Canbaz, RN,Msc principal investigator
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video program and A mobile application in people with Cognitive Impairment and Diabetes Mellitus, Type 2, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hande Bulut Canbaz, RN,Msc (00905426686310, habulut@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive profile (time frame: The moment it is included in the study, 3rd month, 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.