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Sponsors and Collaborators: |
The Vardal Institute Lund University Hospital Sahlgren´s University Hospital |
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Information provided by: | The Vardal Institute |
ClinicalTrials.gov Identifier: | NCT00804232 |
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:
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 |
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Diabetes, Type I |
Behavioral: childhood diabetes |
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 |
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 |
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1: Experimental
effects on child health of family-based home care compared to traditional hospital-based care,
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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.
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Ages Eligible for Study: | 3 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Kristian Bolin, PhD | +46 462220654 | Kristian.Bolin@nek.lu.se |
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 |
Responsible Party: | Inger Hallstrom, Lund University; Gun Forsander, Sahlgrenska University Hospital ( principal investigators: inger Hallsgtröm; Gun Forsander ) |
Study ID Numbers: | DiabetesVardal |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804232 |
Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Diabetes type1; children |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |