Type 2 Diabetes MellitusNCT05919706
Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients
A study testing Patient Education with Game-Based Mobile Technology and Motivational Interviewing in people with Type 2 Diabetes Mellitus and Gaming, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Gaming, Motivational Interviewing
- What is being tested?
- Patient Education with Game-Based Mobile Technology and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2022to 3 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
- Being on oral antidiabetic and/or insulin therapy,
- Having a smart phone and knowing how to use it,
- Internet connection (to install mobile technology application),
- Not having participated in motivational interviewing (MG) training before,
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- Not having vision and hearing problems,
- Not having a communication problem,
- To be able to read, write and speak Turkish,
- Volunteering to participate in the study and continue the study process.
Who cannot join
- Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
- Having serious health problems that prevent participation in motivational interviewing,
- Using steroid therapy,
- Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
- Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
- Being unwilling to participate in the study and/or not wanting to continue the study process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients
Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.
Read the detailed description
A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.
- Conditions
- Type 2 Diabetes Mellitus, Gaming, Motivational Interviewing, Self-Management, Quality of Life, Mobile Technology
- Being tested
- Patient Education with Game-Based Mobile Technology and Motivational Interviewing
- Keywords
- Type 2 Diabetes, Self-Management, Quality of Life, Satisfaction, Nursing, Mobile Technology, Gaming, Motivational Interviewing
- Medical subject headings
- Diabetes Mellitus, Type 2, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education with Game-Based Mobile Technology and Motivational InterviewingBehavioural
Education program, game-based mobile technology and motivational interview were applied to the patients in the experimental group. The patients' self-management, quality of life, and satisfaction level scores for the intervention were determined.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale (DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test, a educational program and a game-based mobile technology application were carried out for 4 weeks, 2 days a week at intervals. After the educational program were completed, motivational interviews were conducted once a week for 4 weeks. In this process, it was ensured that the game-based mobile technology application continued. Post-test data were collected with DSMQ and SF-36 at 2 months (8 weeks after the pre-test). After the post-test, the patients were followed up for 4 weeks. After the follow, with the Patient Information and Follow-up Form, DSMQ, SF-36, and the Satisfaction Questionnaire the follow-test data was collected. Receives: Behavioral: Patient Education with Game-Based Mobile Technology and Motivational Interviewing |
| Control Group | No intervention | Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test data were collected, no intervention was applied to the patients for 3 months (12 weeks), except for routine nursing care. Posttest data were collected with DSMQ and SF-36 2 months (8 weeks) after the pretest data. After the last test, the patients were followed up for 4 weeks, and 3 months (12 weeks) after the start of the study, the Patient Information and Follow-up Form (only the parts containing the features related to the disease and metabolic control variables), DSMQ and SF-36 Scale and follow-up test data were collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSMQ
The scale is of a four-point Likert type. The scale has 4 sub-dimensions as "Glucose Management, Diet Control, Physical Activity, Health-Care Use" and a total score. The lowest score of the scale is 0 points and the highest score is 10 points. The higher the score, the higher the diabetes self-management.
Measured: Last 8 weeks
SF-36
The scale consists of 36 items and 8 sub-dimensions. 8 sub-dimensions have 2 summary sub-dimensions as "Physical Health and Mental Health". There is no total score in the scale. A score between 0-100 is evaluated with sub-dimensions (0: Poor Health, 100: Good Health). Low scores on the scale indicate poor health, while high scores indicate good health.
Measured: Last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start6 Oct 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a randomized controlled experimental study with pretest-posttest-follow-up test.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Kılıç Barmanpek, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919706
- Sponsor's protocol ID
- Diabetes Mellitus and Mobile
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can be reviewed by other researchers after the study has been published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05919706
- Acronym / sponsor ID
- Diabetes Mellitus and Mobile
- Conditions
- Type 2 Diabetes Mellitus, Gaming, Motivational Interviewing, Self-Management, Quality of Life, Mobile Technology
- Keywords
- Type 2 Diabetes, Self-Management, Quality of Life, Satisfaction, Nursing, Mobile Technology, Gaming, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 26 Jun 2023 (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.
Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.
Detailed description
A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted as a randomized controlled experimental study with pretest-posttest-follow-up test.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Patient Education with Game-Based Mobile Technology and Motivational InterviewingPre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale (DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test, a educational program and a game-based mobile technology application were carried out for 4 weeks, 2 days a week at intervals. After the educational program were completed, motivational interviews were conducted once a week for 4 weeks. In this process, it was ensured that the game-based mobile technology application continued. Post-test data were collected with DSMQ and SF-36 at 2 months (8 weeks after the pre-test). After the post-test, the patients were followed up for 4 weeks. After the follow, with the Patient Information and Follow-up Form, DSMQ, SF-36, and the Satisfaction Questionnaire the follow-test data was collected. |
| Control Group | No intervention | –Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test data were collected, no intervention was applied to the patients for 3 months (12 weeks), except for routine nursing care. Posttest data were collected with DSMQ and SF-36 2 months (8 weeks) after the pretest data. After the last test, the patients were followed up for 4 weeks, and 3 months (12 weeks) after the start of the study, the Patient Information and Follow-up Form (only the parts containing the features related to the disease and metabolic control variables), DSMQ and SF-36 Scale and follow-up test data were collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being 18 years or older,
- Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
- Being on oral antidiabetic and/or insulin therapy,
- Having a smart phone and knowing how to use it,
- Internet connection (to install mobile technology application),
Key exclusion criteria (6 listed)
- Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
- Having serious health problems that prevent participation in motivational interviewing,
- Using steroid therapy,
- Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
- Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
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 |
|---|---|---|
| Patient Education with Game-Based Mobile Technology and Motivational InterviewingEducation program, game-based mobile technology and motivational interview were applied to the patients in the experimental group. The patients' self-management, quality of life, and satisfaction level scores for the intervention were determined. | Behavioural | Experimental Group |
Primary outcome
DSMQ
Time frame: Last 8 weeks
The scale is of a four-point Likert type. The scale has 4 sub-dimensions as "Glucose Management, Diet Control, Physical Activity, Health-Care Use" and a total score. The lowest score of the scale is 0 points and the highest score is 10 points. The higher the score, the higher the diabetes self-management.
SF-36
Time frame: Last 4 weeks
The scale consists of 36 items and 8 sub-dimensions. 8 sub-dimensions have 2 summary sub-dimensions as "Physical Health and Mental Health". There is no total score in the scale. A score between 0-100 is evaluated with sub-dimensions (0: Poor Health, 100: Good Health). Low scores on the scale indicate poor health, while high scores indicate good health.
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 27 Jun 2023.
- Individual participant dataSharing planned: Yes. Can be reviewed by other researchers after the study has been published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education with Game-Based Mobile Technology and Motivational Interviewing in people with Type 2 Diabetes Mellitus and Gaming, run by Inonu 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 10 inclusion and 6 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 27 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?
DSMQ (time frame: Last 8 weeks). The study lists 2 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 27 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.