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NCT01191866 Clinical Trial

Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01191866
Other study ID # 0406
Secondary ID
Status Recruiting
Phase N/A
First received August 29, 2010
Last updated August 30, 2010
Start date September 2009

Study information
Verified date August 2010
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Primary Objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. Secondary Objective is to provide an opportunity, through quality of life (QOL) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• psychosocial intervention
The interventions will include an art therapist, a social worker and volunteer work under the supervision of a diabetes nurse. These therapies will be given to selected patients based on individual needs. We will use existing questionnaires in order to identify problematic areas and quantify quality of life

Locations
Country Name City State
Israel Assaf Harofeh Pediatric Diabetes Clinic Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

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