Diabetes Mellitus, Type 1NCT04608058
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling
A study testing Digital storytelling training and Routine training in people with Diabetes Mellitus, Type 1 and Self-Management, run by Nahid Zarifsanaiey at 1 site in Iran.
Trial summary
The aim of this study was to evaluate the effects of digital storytelling on the Self-Management behavior of adolescents with type 1 diabetes (TID). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Self-Management
- What is being tested?
- Digital storytelling training and Routine training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 30 Jul 2019to 30 Apr 2020
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescents with TID
- using medication (insulin)
- willing to participate in the study and complete the informed consent
- having a basic knowledge of working with computers
- ability to communicate on the telephone.
Who cannot join
- physical or mental disabilities
- take anti-anxiety or antidepressant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Self-management Behaviors Education Through Digital Storytelling Method and Conventional Method in Adolescents With Type 1 Diabetes Referred to Diabetes Clinic in Hospitals Affiliated to Shiraz University of Medical Sciences.
The aim of this study was to evaluate the effects of digital storytelling on the Self-Management behavior of adolescents with type 1 diabetes (TID).
Read the detailed description
In this single-blind randomized controlled trial, 60 eligible adolescents with TID were selected based on a convenient sampling method. Next, the participants were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n=30) or control (training with conventional) n=30) groups. Before and three months after the intervention the patients' levels of self-management behaviors according to Self-Management of TID amongst adolescents (SMOD-A); in addition to the Glycated Hemoglobin test (HbA1c) were measured.
- Conditions
- Diabetes Mellitus, Type 1, Self-Management
- Being tested
- Digital storytelling training, Routine training
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital storytelling trainingBehavioural
The digital content in this study is called "Diabetes and Bumblebee". It features 35 minutes of animation that provides children with a brief description of the disease, its symptoms and complications, treatment methods, the type of insulin, how to preserve insulin, the importance of nutrition and exercise in treating diabetes as well as efficient communication and collaboration with parents and healthcare providers. Exciting and interactive animations were used to depict the daily life of a adolescence with diabetes.
Routine trainingBehavioural
The control group received the clinics' routine training include face to face class education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | At first, participants' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, asynchronous Diabetes self-management training, using digital storytelling was made available to this group. Post-test data were collected 3 months after the pretest. Receives: Behavioral: Digital storytelling training |
| No Intervention | Experimental | At first, participants' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, the control group received the clinics' routine training. Post-test data were collected 3 months after the pretest. Receives: Behavioral: Routine training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-management behavior
Self-Management of TID in Adolescence (SMOD-A) questionnaire which includes 48 items in 5 domains; cooperation with Parents, Diabetes care activities, Diabetes Problem-Solving, Diabetes Communication, and Goal in Diabetes. Each item is scored on a 4-point Likert scale ranging from 0 (never) to 3 (always). Higher scores are associated with better self-management behaviors.
Measured: 3 months
Secondary outcomes (1)
Change in Glycated hemoglobin A1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start30 Jul 2019
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nahid Zarifsanaiey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahid Zarifsanaiey, Shiraz University of Medical Sciences
- Investigators
- Nahid zarifsanaiey, Principal investigator, associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608058
- Sponsor's protocol ID
- 1398.244
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self-management Behaviors Education Through Digital Storytelling Method and Conventional Method in Adolescents With Type 1 Diabetes Referred to Diabetes Clinic in Hospitals Affiliated to Shiraz University of Medical Sciences.
- ClinicalTrials.gov ID
- NCT04608058
- Acronym / sponsor ID
- 1398.244
- Conditions
- Diabetes Mellitus, Type 1, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nahid ZarifsanaieyUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 29 Oct 2020 (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 this study was to evaluate the effects of digital storytelling on the Self-Management behavior of adolescents with type 1 diabetes (TID).
Detailed description
In this single-blind randomized controlled trial, 60 eligible adolescents with TID were selected based on a convenient sampling method. Next, the participants were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n=30) or control (training with conventional) n=30) groups. Before and three months after the intervention the patients' levels of self-management behaviors according to Self-Management of TID amongst adolescents (SMOD-A); in addition to the Glycated Hemoglobin test (HbA1c) were measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digital storytelling trainingAt first, participants' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, asynchronous Diabetes self-management training, using digital storytelling was made available to this group. Post-test data were collected 3 months after the pretest. |
| No Intervention | Experimental | Behavioral: Routine trainingAt first, participants' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, the control group received the clinics' routine training. Post-test data were collected 3 months after the pretest. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- adolescents with TID
- using medication (insulin)
- willing to participate in the study and complete the informed consent
- having a basic knowledge of working with computers
- ability to communicate on the telephone.
Key exclusion criteria (2 listed)
- physical or mental disabilities
- take anti-anxiety or antidepressant medication
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 |
|---|---|---|
| Digital storytelling trainingThe digital content in this study is called "Diabetes and Bumblebee". It features 35 minutes of animation that provides children with a brief description of the disease, its symptoms and complications, treatment methods, the type of insulin, how to preserve insulin, the importance of nutrition and exercise in treating diabetes as well as efficient communication and collaboration with parents and healthcare providers. Exciting and interactive animations were used to depict the daily life of a adolescence with diabetes. | Behavioural | Intervention |
| Routine trainingThe control group received the clinics' routine training include face to face class education. | Behavioural | No Intervention |
Primary outcome
Change in Self-management behavior
Time frame: 3 months
Self-Management of TID in Adolescence (SMOD-A) questionnaire which includes 48 items in 5 domains; cooperation with Parents, Diabetes care activities, Diabetes Problem-Solving, Diabetes Communication, and Goal in Diabetes. Each item is scored on a 4-point Likert scale ranging from 0 (never) to 3 (always). Higher scores are associated with better self-management behaviors.
1 secondary outcome
Change in Glycated hemoglobin A1c
Time frame: 3 months
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 2 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nahid zarifsanaiey principal investigator
associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital storytelling training and Routine training in people with Diabetes Mellitus, Type 1 and Self-Management, run by Nahid Zarifsanaiey at 1 site in Iran.
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 2 Nov 2020. 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 Iran. 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?
Change in Self-management behavior (time frame: 3 months). 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 2 Nov 2020.