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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04608058
Other study ID # 1398.244
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 30, 2019
Est. completion date April 30, 2020

Study information

Verified date October 2020
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

Behavioral:
Digital storytelling training
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 training
The control group received the clinics' routine training include face to face class education.

Locations

Country Name City State
Iran, Islamic Republic of Shiraz University of Medical Sciences Shiraz Fars

Sponsors (1)

Lead Sponsor Collaborator
Nahid Zarifsanaiey

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary Change in Glycated hemoglobin A1c 3 months
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