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Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling

Primary Purpose

Diabetes Mellitus, Type 1, Self-Management

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Digital storytelling training
Routine training
Sponsored by
Nahid Zarifsanaiey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

No Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Glycated hemoglobin A1c

Full Information

First Posted
October 27, 2020
Last Updated
October 29, 2020
Sponsor
Nahid Zarifsanaiey
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1. Study Identification

Unique Protocol Identification Number
NCT04608058
Brief Title
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nahid Zarifsanaiey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Self-Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital storytelling training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine training
Intervention Description
The control group received the clinics' routine training include face to face class education.
Primary Outcome Measure Information:
Title
Change in Self-management behavior
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Glycated hemoglobin A1c
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahid zarifsanaiey
Organizational Affiliation
associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling

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