- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04608058
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling
October 29, 2020 updated by: Nahid Zarifsanaiey
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of
- Shiraz University of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- physical or mental disabilities
- take anti-anxiety or antidepressant medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
Experimental: No Intervention
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.
|
The control group received the clinics' routine training include face to face class education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Glycated hemoglobin A1c
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nahid zarifsanaiey, associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
October 27, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
October 29, 2020
Study Record Updates
Last Update Posted (Actual)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1398.244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.