Diabetes Mellitus, Type 2NCT05151276
Mobile Phone-based Video Education on Diabetes
A study testing mobile phone-based distance video education group in people with Diabetes Mellitus, Type 2, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of mobile phone-based distance video education given to individuals with type 2 diabetes on metabolic variables and cognitive-social factors. This study is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- mobile phone-based distance video education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jul 2019
- 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.
- Being between the ages of 18-65.
- Being on oral antidiabetic and/or insulin therapy.
- Having a mobile phone capable of receiving and playing video messages.
- Volunteering to participate in the study.
- Sensory losses such as hearing and speech that will prevent communication
Who cannot join
- Being under 18 years of age
- Not having a mobile phone capable of receiving and playing video messages
- Not willing to participate in the study
- Having sensory loss such as hearing and speaking that prevents communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balıkesir University
Balıkesir, Altıeylül, 10100
About this study
Official title: Effectiveness of Mobile Phone-based Distance Video Education in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
This study aimed to examine the effect of mobile phone-based distance video education given to individuals with type 2 diabetes on metabolic variables and cognitive-social factors. This study is a randomized controlled trial.
Read the detailed description
MATERIALS AND METHODS:
This study is a randomized controlled trial.
Participants:
The population of the study consisted of individuals with type 2 diabetes who presented to hospital diabetes outpatient clinic between July 2018 and January 2019, and the study sample, on the other hand, included a total of 100 individuals with type 2 diabetes who met the inclusion criteria and agreed to participate in the study. The study was completed with a total of 93 subjects, including 46 in the intervention group (n = 46) and 47 in the control group (n= 47). A Diagnosis and Follow-up Form for Individuals with Diabetes (socio-demographic characteristics, diabetes-related characteristics, metabolic values), which was prepared by the researcher in line with the literature, and the Turkish Multidimensional Diabetes Questionnaire (T-MDDQ) were used to collect the data.
Preparation and content of the education material:
The education material was based on four different guidelines, namely, educator's guidelines for adults with diabetes; the diagnosis, treatment, and follow-up guidelines for diabetes mellitus and its complications; diabetes diagnosis and treatment guidelines; and international education guidelines for diabetes health professionals. The diabetes education videos prepared and presented by the researcher in line with these resources were sent to the participants' smartphones in parts. The educational content consisted of 8 sections: what is diabetes? (basic concepts, symptoms, diagnostic criteria, importance), medical nutrition therapy in diabetes, exercise therapy in diabetes, medical treatment in diabetes, acute complications of diabetes, chronic complications of diabetes, foot problems in diabetes, life with diabetes, and diabetes management under special cases.
Data collection process:
The intervention group: In the first meeting, the individuals in the intervention group were informed about the video-based diabetes education and how they would get the videos, and data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. After the administration of the forms, blood pressure, height, and weight measurements were made, and the first interview was completed. Following the first interview, diabetes education videos created previously were sent to the mobile phones of the individuals in two episodes a week fashion. Video submission was completed in a total of four weeks. In the second interview, three months after the video submission had been completed, data collection forms were re-administered to the individuals, and blood analysis results were recorded. The interview was completed after measuring their blood pressure and weight. During the period between the first and second interviews, the individuals continued to receive routine outpatient follow-ups.
The control group: In the first interview, the individuals with diabetes in the control group were given information about the study, and then data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. The first interview was completed after blood pressure, height, and weight measurements were made. Later, individuals continued to receive routine outpatient follow-ups without any other procedures. In the second interview held three months later, data collection forms were re-administered, and blood analysis results, blood pressure, and weight measurements were recorded. At the end of the second interview, diabetes education videos were sent to the individuals in the control group, too, and they were provided with the same education.
Data analysis:
The statistical package for social science (SPSS) version 25.0 (IBM Corp. Armonk, NY) was used to analyze the data. P<.05 was accepted statistically significant. In descriptive statistics, mean, ± standard deviation, median, minimum and maximum values, and percentages were used, and in nonparametric tests, Mann-Whitney U, Pearson's chi-square, Fisher's exact test, McNemar's test, Wilcoxon signed ranks test, and Spearman's rho measurements were employed.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- mobile phone-based distance video education group
- Keywords
- Type 2 diabetes, diabetes education, mobile phone-based, distance video education, randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile phone-based distance video education groupBehavioural
Following the first interview, diabetes education videos created previously were sent to the mobile phones of the individuals in two episodes a week fashion. Video submission was completed in a total of four weeks. In the second interview, three months after the video submission had been completed, data collection forms were re-administered to the individuals, and blood analysis results were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | individuals with odd sequence numbers were assigned to the intervention group (n=46) Receives: Behavioral: mobile phone-based distance video education group |
| Control Group | No intervention | those with even numbers to the control group (n=47). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish Multidimensional Diabetes Questionnaire
Change from baseline diabetes-related cognitive and social factors at 3 months. Responses were on a Likert-type scale (0-not at all significant).
not, 100-very important) is marked. High school scores perceived self-efficacy and outcome indicates high expectations.
Measured: pre-test (baseline), post-test (3 months follow-up)
Secondary outcomes (6)
HbA1C
HbA1C-change from baseline HbA1C at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
glucose
glucose -change from baseline glucose at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
total cholesterol
total cholesterol -change from baseline total cholesterol at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
HDL
HDL -change from baseline HDL at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
LDL
LDL -change from baseline LDL at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
triglyceride
triglyceride -change from baseline triglyceride at 3 months
Measured: pre-test (baseline), post-test (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jul 2018
- Primary completion31 Jan 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Tekir, Balikesir University
- Investigators
- Ali Kamil Bayraktar, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151276
- Sponsor's protocol ID
- BAUN"OTEKİR-001
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2021
- Last updated
- 9 Dec 2021
- 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 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Phone-based Distance Video Education in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05151276
- Acronym / sponsor ID
- BAUN"OTEKİR-001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, diabetes education, mobile phone-based, distance video education, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 9 Dec 2021 (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.
This study aimed to examine the effect of mobile phone-based distance video education given to individuals with type 2 diabetes on metabolic variables and cognitive-social factors. This study is a randomized controlled trial.
Detailed description
MATERIALS AND METHODS:
This study is a randomized controlled trial.
Participants:
The population of the study consisted of individuals with type 2 diabetes who presented to hospital diabetes outpatient clinic between July 2018 and January 2019, and the study sample, on the other hand, included a total of 100 individuals with type 2 diabetes who met the inclusion criteria and agreed to participate in the study. The study was completed with a total of 93 subjects, including 46 in the intervention group (n = 46) and 47 in the control group (n= 47). A Diagnosis and Follow-up Form for Individuals with Diabetes (socio-demographic characteristics, diabetes-related characteristics, metabolic values), which was prepared by the researcher in line with the literature, and the Turkish Multidimensional Diabetes Questionnaire (T-MDDQ) were used to collect the data.
Preparation and content of the education material:
The education material was based on four different guidelines, namely, educator's guidelines for adults with diabetes; the diagnosis, treatment, and follow-up guidelines for diabetes mellitus and its complications; diabetes diagnosis and treatment guidelines; and international education guidelines for diabetes health professionals. The diabetes education videos prepared and presented by the researcher in line with these resources were sent to the participants' smartphones in parts. The educational content consisted of 8 sections: what is diabetes? (basic concepts, symptoms, diagnostic criteria, importance), medical nutrition therapy in diabetes, exercise therapy in diabetes, medical treatment in diabetes, acute complications of diabetes, chronic complications of diabetes, foot problems in diabetes, life with diabetes, and diabetes management under special cases.
Data collection process:
The intervention group: In the first meeting, the individuals in the intervention group were informed about the video-based diabetes education and how they would get the videos, and data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. After the administration of the forms, blood pressure, height, and weight measurements were made, and the first interview was completed. Following the first interview, diabetes education videos created previously were sent to the mobile phones of the individuals in two episodes a week fashion. Video submission was completed in a total of four weeks. In the second interview, three months after the video submission had been completed, data collection forms were re-administered to the individuals, and blood analysis results were recorded. The interview was completed after measuring their blood pressure and weight. During the period between the first and second interviews, the individuals continued to receive routine outpatient follow-ups.
The control group: In the first interview, the individuals with diabetes in the control group were given information about the study, and then data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. The first interview was completed after blood pressure, height, and weight measurements were made. Later, individuals continued to receive routine outpatient follow-ups without any other procedures. In the second interview held three months later, data collection forms were re-administered, and blood analysis results, blood pressure, and weight measurements were recorded. At the end of the second interview, diabetes education videos were sent to the individuals in the control group, too, and they were provided with the same education.
Data analysis:
The statistical package for social science (SPSS) version 25.0 (IBM Corp. Armonk, NY) was used to analyze the data. P<.05 was accepted statistically significant. In descriptive statistics, mean, ± standard deviation, median, minimum and maximum values, and percentages were used, and in nonparametric tests, Mann-Whitney U, Pearson's chi-square, Fisher's exact test, McNemar's test, Wilcoxon signed ranks test, and Spearman's rho measurements were employed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: mobile phone-based distance video education groupindividuals with odd sequence numbers were assigned to the intervention group (n=46) |
| Control Group | No intervention | –those with even numbers to the control group (n=47). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a diagnosis of Type 2 diabetes mellitus for at least 6 months.
- Being between the ages of 18-65.
- Being on oral antidiabetic and/or insulin therapy.
- Having a mobile phone capable of receiving and playing video messages.
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- Being under 18 years of age
- Not having a mobile phone capable of receiving and playing video messages
- Not willing to participate in the study
- Having sensory loss such as hearing and speaking that prevents 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 |
|---|---|---|
| mobile phone-based distance video education groupFollowing the first interview, diabetes education videos created previously were sent to the mobile phones of the individuals in two episodes a week fashion. Video submission was completed in a total of four weeks. In the second interview, three months after the video submission had been completed, data collection forms were re-administered to the individuals, and blood analysis results were recorded. | Behavioural | Intervention Group |
Primary outcome
The Turkish Multidimensional Diabetes Questionnaire
Time frame: pre-test (baseline), post-test (3 months follow-up)
Change from baseline diabetes-related cognitive and social factors at 3 months. Responses were on a Likert-type scale (0-not at all significant). not, 100-very important) is marked. High school scores perceived self-efficacy and outcome indicates high expectations.
6 secondary outcomes
HbA1C
Time frame: pre-test (baseline), post-test (3 months follow-up)
glucose
Time frame: pre-test (baseline), post-test (3 months follow-up)
total cholesterol
Time frame: pre-test (baseline), post-test (3 months follow-up)
HDL
Time frame: pre-test (baseline), post-test (3 months follow-up)
LDL
Time frame: pre-test (baseline), post-test (3 months follow-up)
triglyceride
Time frame: pre-test (baseline), post-test (3 months follow-up)
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 9 Dec 2021.
- 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.
Ali Kamil Bayraktar principal investigator
Balikesir 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 mobile phone-based distance video education group in people with Diabetes Mellitus, Type 2, run by Balikesir 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 6 inclusion and 4 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 9 Dec 2021. 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?
The Turkish Multidimensional Diabetes Questionnaire (time frame: pre-test (baseline), post-test (3 months follow-up)). 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 9 Dec 2021.