DSME or DSME + MI in T1DM on Glycemic Control

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

Sponsors

Lead Sponsor: Mahidol University

Source Mahidol University
Brief Summary

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.

Overall Status Unknown status
Start Date October 2016
Completion Date October 2018
Primary Completion Date October 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1C at the beginning of the study, 3 month and 6 months later
Secondary Outcome
Measure Time Frame
Pre and post test scores for Diabetic knowledge at the beginning and 6 months later
Diabetic self-care behavior score at the beginning and 6 months later
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Motivational interviewing

Arm Group Label: DSME+MI

Intervention Type: Drug

Intervention Name: DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later

Arm Group Label: DSME

Eligibility

Criteria:

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

Gender: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ornsuda Lertbannaphong, MD Principal Investigator Endocrinology Division, Pediatrics department, Siriraj Hospital
Overall Contact

Last Name: Ornsuda Lertbannaphong, MD

Phone: 6624197000

Phone Ext.: 95676

Email: [email protected]

Location
Facility: Status: Contact: Ornsuda Lertbannaphong Ornsuda Lertbannaphong, MD 024197000 5676 [email protected]
Location Countries

Thailand

Verification Date

April 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: DSME

Type: Active Comparator

Description: participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later

Label: DSME+MI

Type: Experimental

Description: 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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov