Back to resultsMICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Michael Method
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Metabolic Control, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes at least 1 year prior to study inclusion
- 12-17 years old
- HbA1c > 7.8%
Exclusion Criteria:
- Incapability to comply with all study requirements
Sites / Locations
- Schneider Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Michael Method
Arm Description
14 group meeting, taking place once a week during 14 consecutive weeks
Outcomes
Primary Outcome Measures
Metabolic Control measured as HbA1c level
Secondary Outcome Measures
Diabetes Quality of Life questionnaire (DQOLY)
Self assessment questionnaire
Number of severe hypoglycemic events
Number of Diabetic Keto Acidosis events
Full Information
NCT ID
NCT01691287
First Posted
September 19, 2012
Last Updated
April 30, 2014
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01691287
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Metabolic Control, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Michael Method
Arm Type
Experimental
Arm Description
14 group meeting, taking place once a week during 14 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
Michael Method
Primary Outcome Measure Information:
Title
Metabolic Control measured as HbA1c level
Time Frame
at the end of the study - after 15 weeks
Secondary Outcome Measure Information:
Title
Diabetes Quality of Life questionnaire (DQOLY)
Time Frame
At the end of the study- after 15 weeks
Title
Self assessment questionnaire
Time Frame
At the end of the study- after 15 weeks
Title
Number of severe hypoglycemic events
Time Frame
at the end of the study-after 15 weeks
Title
Number of Diabetic Keto Acidosis events
Time Frame
at the end of the study- after 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes at least 1 year prior to study inclusion
12-17 years old
HbA1c > 7.8%
Exclusion Criteria:
- Incapability to comply with all study requirements
Facility Information:
Facility Name
Schneider Medical Center
City
Petah-TTikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
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
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