DSME or DSME + MI in T1DM on Glycemic Control

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2018

Interventions

  • Behavioral: Motivational interviewing
  • Drug: DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later

Arms, Groups and Cohorts

  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ornsuda Lertbannaphong, MD, Principal Investigator, Endocrinology Division, Pediatrics department, Siriraj Hospital
  • Overall Contact(s)
    • Ornsuda Lertbannaphong, MD, 6624197000, ornsuda110@hotmail.com

References

Santiprabhob J, Likitmaskul S, Kiattisakthavee P, Weerakulwattana P, Chaichanwattanakul K, Nakavachara P, Peerapatdit T, Nitiyanant W. Glycemic control and the psychosocial benefits gained by patients with type 1 diabetes mellitus attending the diabetes camp. Patient Educ Couns. 2008 Oct;73(1):60-6. doi: 10.1016/j.pec.2008.05.023. Epub 2008 Jul 7.

Viner RM, Christie D, Taylor V, Hey S. Motivational/solution-focused intervention improves HbA1c in adolescents with Type 1 diabetes: a pilot study. Diabet Med. 2003 Sep;20(9):739-42. doi: 10.1046/j.1464-5491.2003.00995.x.

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