DSME or DSME + MI in T1DM on Glycemic Control

April 1, 2017 updated by: Mahidol University

A Randomized Control Trial Compare Between Diabetic Knowledge and Self-care Behaviors (DSME) With and Without Motivational Interviewing, on Glycemic Control Among Children and Adolescents With Diabetes Mellitus Type 1

This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or DSME plus motivational interviewing on glycemic control among children and adolescents with DM type 1. Half of participants will receive DSME along, while the other half will receive DSME plus MI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Ornsuda Lertbannaphong
        • Contact:

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

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T1DM
  • age more than 10 years old
  • HbA1C more than 8%

Exclusion Criteria:

  • other types of DM
  • receive medications that may effect blood glucose
  • mental retardation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DSME
participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later
Drug: DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later
Experimental: DSME+MI
participants in this arm will receive standard care for diabetes plus motivation interviewing (MI) sessions at the beginning of the study and 3 months later, will also receive motivation interviewing sessions by phone at 1, 2, 4, 5 month after the beginning of the study
Behavioral: Motivational interviewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C
Time Frame: at the beginning of the study, 3 month and 6 months later
at the beginning of the study, 3 month and 6 months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Pre and post test scores for Diabetic knowledge
Time Frame: at the beginning and 6 months later
at the beginning and 6 months later
Diabetic self-care behavior score
Time Frame: at the beginning and 6 months later
at the beginning and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Ornsuda Lertbannaphong, MD, Endocrinology Division, Pediatrics department, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

April 1, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 1, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-DSME-MI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

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