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Childhood Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Vardalinstitutet The Swedish Institute for Health Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804232
First Posted: December 8, 2008
Last Update Posted: December 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lund University Hospital
Sahlgren´s University Hospital
Information provided by:
Vardalinstitutet The Swedish Institute for Health Sciences
  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:

  1. to analyse the effects on child health of family-based home care compared to traditional hospital-based care, and
  2. 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Childhood Diabetes - Family Based Health Interventions for Child Health

Resource links provided by NLM:


Further study details as provided by Vardalinstitutet The Swedish Institute for Health Sciences:

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 ]

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 ]

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
Experimental: 1
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.
Experimental: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804232


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

Locations
Sweden
Queen Silvia's Childrens' hospital Recruiting
Gothenburg, Sweden, 41685
Contact: Gun Forsander, PhD    +46 31 3438247    Gun.Forsander@vgregion.se   
Lund University Childrens' hospital Recruiting
Lund, Sweden, 221 00
Contact: Inger Hallström, PhD, Professor    +46 46 2221896    Inger.Hallstrom@med.lu.se   
Sponsors and Collaborators
Vardalinstitutet The Swedish Institute for Health Sciences
Lund University Hospital
Sahlgren´s University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: principal investigators: inger Hallsgtröm; Gun Forsander, Inger Hallstrom, Lund University; Gun Forsander, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT00804232     History of Changes
Other Study ID Numbers: DiabetesVardal
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: December 8, 2008
Last Verified: December 2008

Keywords provided by Vardalinstitutet The Swedish Institute for Health Sciences:
Diabetes type1; children

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases