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

Sponsor

Nahid Zarifsanaiey (Other)

Overall Status

Completed

CT.gov ID

NCT04608058

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Self-Management	Behavioral: Digital storytelling training Behavioral: Routine training	N/A

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

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Jul 30, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

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

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.

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.

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.

Behavioral: Routine training

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

Outcome Measures

Primary Outcome Measures

Change in Self-management behavior [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.

Secondary Outcome Measures

Change in Glycated hemoglobin A1c [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of

Sponsors and Collaborators

Nahid Zarifsanaiey

Investigators

Principal Investigator: Nahid zarifsanaiey, associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nahid Zarifsanaiey, Associate Professor, Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT04608058

Other Study ID Numbers:

1398.244

First Posted:

Oct 29, 2020

Last Update Posted:

Nov 2, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 2, 2020