Childhood Diabetes - Diabetes Clinical Trials - Recruit...

Childhood Diabetes

Childhood Diabetes

This study is currently recruiting participants.
Verified by The Vardal Institute, December 2008
Sponsors and Collaborators: The Vardal Institute
Lund University Hospital
Sahlgren´s University Hospital

Information provided by: The Vardal Institute
ClinicalTrials.gov Identifier: NCT00804232

Purpose
Purpose of the study:

To compare three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.

Specific objectives:

The main objectives of the study are:

to analyse the effects on child health of family-based home care compared to traditional hospital-based care, and
to analyse the effects on child health of family-based psychological treatment compared to traditional hospital-based treatment.
The main focus will be on child health and changes in child health. Several variables will be collected for these purpose (see instruments, below), the main variable being the child's metabolic control. We will also analyse effects on the amount and content of (1) parental efforts (absenteeism from work; time use which is conditional on the child's diabetes etc), and (2) formal health care utilisation of the home-based care and psychological treatment, respectively, compared to traditional care.

Condition Intervention
Diabetes, Type I
Behavioral: childhood diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:Childhood Diabetes - Family Based Health Interventions for Child Health

Further study details as provided by The Vardal Institute:

Primary Outcome Measures:
Primary Outcome Measure: the child's metabolic control as shown in HbA1C [ Time Frame: 6 months, 1 year, 2 year, 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Quality of life, Satisfaction with care, Family impact and family climate, psychological variables, parental absenteeism from work; time use which is conditional on the child's diabetes etc), formal health care utilisation [ Time Frame: 6 months, 1 year, 2 year, 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment:210
Study Start Date:January 2008
Estimated Study Completion Date:December 2015
Estimated Primary Completion Date:September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
effects on child health of family-based home care compared to traditional hospital-based care, Behavioral: childhood diabetes
the intervention compares three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.
2: Experimental
effects on child health of family-based psychological treatment compared to traditional hospital-based treatment Behavioral: childhood diabetes
the intervention compares three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.

Show Detailed Description

Eligibility
Ages Eligible for Study:3 Years to 15 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Inclusion Criteria:

children, aged 3 - 15
newly diagnosed with diabetes mellitus
no other chronic illnesses
Swedish as mother tongue
no siblings with type 1 diabetes
not objects for social interventions
Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804232

Contacts
Contact: Kristian Bolin, PhD +46 462220654 Kristian.Bolin@nek.lu.se

Locations
Sweden
Lund University Childrens' hospital Recruiting
Lund, Sweden, 221 00
Contact: Inger Hallström, PhD, Professor +46 46 2221896 Inger.Hallstrom@med.lu.se
Queen Silvia's Childrens' hospital Recruiting
Gothenburg, Sweden, 41685
Contact: Gun Forsander, PhD +46 31 3438247 Gun.Forsander@vgregion.se

Sponsors and Collaborators
The Vardal Institute
Lund University Hospital
Sahlgren´s University Hospital

Responsible Party:Inger Hallstrom, Lund University; Gun Forsander, Sahlgrenska University Hospital ( principal investigators: inger Hallsgtröm; Gun Forsander )
Study ID Numbers:DiabetesVardal
First Received:December 5, 2008
Last Updated:December 5, 2008
ClinicalTrials.gov Identifier:NCT00804232 [history]
Health Authority:Sweden: Swedish National Council on Medical Ethics

Keywords provided by The Vardal Institute:
Diabetes type1; children

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases