NCT01191866

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

2 years

First QC Date

August 29, 2010

Last Update Submit

August 30, 2010

Conditions

Keywords

diabetes mellituspsychosocialmetabolic controlquality of life questionnaireschildrenadolescents

Study Arms (1)

Diabetes mellitus

All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic

Behavioral: psychosocial intervention

Interventions

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

Diabetes mellitus

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Pediatric Diabetes Clinic

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 29, 2010

First Posted

August 31, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Last Updated

August 31, 2010

Record last verified: 2010-08

Locations