Education, PatientNCT05926388
Video-Assisted Instruction in Type 2 Diabetes Patients
A study testing Video-assisted training in people with Education, Patient, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Education, Patient
- What is being tested?
- Video-assisted training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 10 Aug 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
- 18-65 years
- No hearing or communication problems
- Self-injecting insulin
Who cannot join
- Health care professionals
- Chronic complications
- Pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
izmir Bakircay University
Izmir, Menemen, 35160
About this study
Official title: The Effect of Video-Assisted Instruction in Type 2 Diabetes Patients' Insulin Self-Management and Insulin Administration Skills
The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
Read the detailed description
The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
- Conditions
- Education, Patient
- Being tested
- Video-assisted training
- Keywords
- self-management, Type 2 diabetes mellitus, video-assisted instruction
- 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.
Video-assisted trainingOther
Patients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods.
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted training group | Experimental | The researcher will train the patients with video-assisted on insulin therapy and administration. Receives: Other: Video-assisted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Treatment Self-Management Scale 1 (Questionnaire)
Patients' self-injection practices will be evaluated.
Measured: Seven days after the training
Insulin Treatment Self-Management Scale 2 (Questionnaire)
Patients' self-injection practices will be evaluated.
Measured: Five weeks after the training
Insulin Administration Observation Form 1
The scale identifies knowledge and skill levels of patients.
Measured: Seven days after the training
Insulin Administration Observation Form 2
The scale identifies knowledge and skill levels of patients.
Measured: Five weeks after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Jan 2022
- Primary completion10 May 2022
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, PatientStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Günay İsmailoğlu, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926388
- Sponsor's protocol ID
- BU-SBF-EI-001
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2023
- Last updated
- 18 Dec 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Instruction in Type 2 Diabetes Patients' Insulin Self-Management and Insulin Administration Skills
- ClinicalTrials.gov ID
- NCT05926388
- Acronym / sponsor ID
- BU-SBF-EI-001
- Conditions
- Education, Patient
- Keywords
- self-management, Type 2 diabetes mellitus, video-assisted instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 3 Jul 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.
The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
Detailed description
The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video-assisted training group | Experimental | Other: Video-assisted trainingThe researcher will train the patients with video-assisted on insulin therapy and administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years
- No hearing or communication problems
- Self-injecting insulin
Key exclusion criteria (3 listed)
- Health care professionals
- Chronic complications
- Pregnant
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 |
|---|---|---|
| Video-assisted trainingPatients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods. | Other | Video-assisted training group |
Primary outcome
Insulin Treatment Self-Management Scale 1 (Questionnaire)
Time frame: Seven days after the training
Patients' self-injection practices will be evaluated.
Insulin Treatment Self-Management Scale 2 (Questionnaire)
Time frame: Five weeks after the training
Patients' self-injection practices will be evaluated.
Insulin Administration Observation Form 1
Time frame: Seven days after the training
The scale identifies knowledge and skill levels of patients.
Insulin Administration Observation Form 2
Time frame: Five weeks after the training
The scale identifies knowledge and skill levels of patients.
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 18 Dec 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.
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 Video-assisted training in people with Education, Patient, run by Izmir Bakircay 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 3 inclusion and 3 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 18 Dec 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?
Insulin Treatment Self-Management Scale 1 (Questionnaire) (time frame: Seven days after the training). 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 18 Dec 2023.