MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes
1 other identifier
interventional
23
1 country
1
Brief Summary
Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well. Compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age. The Michael Method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. The method was developed in 1988 by a multi-disciplinary team of professional academic in Israel. Today the Israeli education system implements the method in Junior High Schools and High Schools in diverse educational sectors. The program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the Ministries of Defense and Social Welfare, the National Insurance Institute, the National Electric Corporation and in many other public and private frameworks. The proposed study is aimed to assess whether the Michael Method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
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
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 1, 2014
April 1, 2014
1.2 years
September 19, 2012
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Control measured as HbA1c level
at the end of the study - after 15 weeks
Secondary Outcomes (4)
Diabetes Quality of Life questionnaire (DQOLY)
At the end of the study- after 15 weeks
Self assessment questionnaire
At the end of the study- after 15 weeks
Number of severe hypoglycemic events
at the end of the study-after 15 weeks
Number of Diabetic Keto Acidosis events
at the end of the study- after 15 weeks
Study Arms (1)
Michael Method
EXPERIMENTAL14 group meeting, taking place once a week during 14 consecutive weeks
Interventions
Eligibility Criteria
You may qualify if:
- years old
- HbA1c \> 7.8%
You may not qualify if:
- \- Incapability to comply with all study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Medical Center
Petah-TTikva, 49202, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 24, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 1, 2014
Record last verified: 2014-04