Type 2 DiabetesNCT05202470
Effectiveness of Telehealth Program in Patients With Type 2 Diabetes
A study testing TE and CE in people with Type 2 Diabetes, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- TE and CE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2022to 15 May 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
- Those between the ages of 18-65,
- Receiving oral antidiabetic and/or insulin therapy,
- Having a mobile phone capable of receiving and playing video messages,
- Does not have hearing, speech and psychiatric problems that prevent communication,
Who cannot join
- Individuals who do not volunteered to participate in the study
- Patients who have hearing, speech and psychiatric problems that prevent communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Training and Research Hospital
Muğla, 48000
About this study
Official title: Effectiveness of Telehealth Program in Patients With Type 2 Diabetes: Randomized Controlled Study
Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.
Read the detailed description
The use of telehealth technologies in the field of health is becoming more and more widespread. Telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.
- Conditions
- Type 2 Diabetes
- Being tested
- TE, CE
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOther
After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.
CEOther
After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Education (TE) | Experimental | After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks. Receives: Other: TE |
| Conventional Education (CE) | Active comparator | Paper-based education forms will be given to the patients in the first group. Face-to-face conventional diabetes education will be carried out. Receives: Other: CE |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Survey of Physical Activity (IPAQ)
Physical activity assessment
Measured: 4 weeks
Goal orientation in exercise measure (GOEM)
Measurement of goal orientation in exercise
Measured: 4 weeks
Mini Nutritional Assessment
To evaluate the nutrition status of the patients
Measured: 4 weeks
The Problem Areas in Diabetes Scale (PADS)
PADS evaluates comprehensive diabetes evaluation. A total score is ranged between 0 - 100. Patients scoring 40 or higher may be at the level of "emotional burnout" and warrant special attention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start6 Jan 2022
- Primary completion10 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Serap Tuna, PhD, Study chair, Muğla Sıtkı Koçman UniversityEmine Neşe Yeniçeri, MD, Principal investigator, Muğla Sıtkı Koçman UniversityCem Şahin, MD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202470
- Sponsor's protocol ID
- Mugla Sıtkı Kocman
- Status last verified
- Jun 2023
- First submitted
- 9 Jan 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telehealth Program in Patients With Type 2 Diabetes: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05202470
- Acronym / sponsor ID
- Mugla Sıtkı Kocman
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 21 Jan 2022 (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.
Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.
Detailed description
The use of telehealth technologies in the field of health is becoming more and more widespread. Telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Education (TE) | Experimental | Other: TEAfter the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks. |
| Conventional Education (CE) | Active comparator | Other: CEPaper-based education forms will be given to the patients in the first group. Face-to-face conventional diabetes education will be carried out. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
- Those between the ages of 18-65,
- Receiving oral antidiabetic and/or insulin therapy,
- Having a mobile phone capable of receiving and playing video messages,
- Does not have hearing, speech and psychiatric problems that prevent communication,
Key exclusion criteria (2 listed)
- Individuals who do not volunteered to participate in the study
- Patients who have hearing, speech and psychiatric problems that prevent communication
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 |
|---|---|---|
| TEAfter the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks. | Other | Telehealth Education (TE) |
| CEAfter the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks. | Other | Conventional Education (CE) |
Primary outcome
International Survey of Physical Activity (IPAQ)
Time frame: 4 weeks
Physical activity assessment
Goal orientation in exercise measure (GOEM)
Time frame: 4 weeks
Measurement of goal orientation in exercise
Mini Nutritional Assessment
Time frame: 4 weeks
To evaluate the nutrition status of the patients
The Problem Areas in Diabetes Scale (PADS)
Time frame: 4 weeks
PADS evaluates comprehensive diabetes evaluation. A total score is ranged between 0 - 100. Patients scoring 40 or higher may be at the level of "emotional burnout" and warrant special attention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Serap Tuna, PhD study chair
Muğla Sıtkı Koçman University
Emine Neşe Yeniçeri, MD principal investigator
Muğla Sıtkı Koçman University
Cem Şahin, MD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TE and CE in people with Type 2 Diabetes, run by Muğla Sıtkı Koçman University 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Survey of Physical Activity (IPAQ) (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 15 Jun 2023.