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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Oct 2016
Typical duration for not_applicable diabetes-mellitus
1 active site
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
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 26, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 7, 2017
April 1, 2017
2 years
March 26, 2017
April 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1C
at the beginning of the study, 3 month and 6 months later
Secondary Outcomes (2)
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
Study Arms (2)
DSME
ACTIVE COMPARATORparticipants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later
DSME+MI
EXPERIMENTALparticipants 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
Interventions
Eligibility Criteria
You may qualify if:
- T1DM
- age more than 10 years old
- HbA1C more than 8%
You may not qualify if:
- other types of DM
- receive medications that may effect blood glucose
- mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ornsuda Lertbannaphong
Bangkok Noi, Bangkok, 10700, Thailand
Related Publications (2)
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.
PMID: 18606522BACKGROUNDViner 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.
PMID: 12925054BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ornsuda Lertbannaphong, MD
Endocrinology Division, Pediatrics department, Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2017
First Posted
April 7, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
April 7, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share