NCT04608058

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 27, 2020

Last Update Submit

October 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Glycated hemoglobin A1c

    3 months

Study Arms (2)

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.

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.

Behavioral: Routine training

Interventions

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

The control group received the clinics' routine training include face to face class education.

No Intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • physical or mental disabilities
  • take anti-anxiety or antidepressant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nahid zarifsanaiey

    associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2020

First Posted

October 29, 2020

Study Start

July 30, 2019

Primary Completion

March 30, 2020

Study Completion

April 30, 2020

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations