NCT00804232

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2008

Status Verified

December 1, 2008

Enrollment Period

2.7 years

First QC Date

December 5, 2008

Last Update Submit

December 5, 2008

Conditions

Diabetes, Type I

Keywords

Diabetes type1; children

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure: the child's metabolic control as shown in HbA1C

    6 months, 1 year, 2 year, 5 year

Secondary Outcomes (1)

  • 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

    6 months, 1 year, 2 year, 5 year

Study Arms (2)

1

EXPERIMENTAL

effects on child health of family-based home care compared to traditional hospital-based care,

Behavioral: childhood diabetes

2

EXPERIMENTAL

effects on child health of family-based psychological treatment compared to traditional hospital-based treatment

Behavioral: childhood diabetes

Interventions

childhood diabetesBEHAVIORAL

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.

12

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Silvia's Childrens' hospital

Gothenburg, 41685, Sweden

RECRUITING

Lund University Childrens' hospital

Lund, 221 00, Sweden

RECRUITING

Related Publications (2)

  • Tiberg I, Lindgren B, Carlsson A, Hallstrom I. Cost-effectiveness and cost-utility analyses of hospital-based home care compared to hospital-based care for children diagnosed with type 1 diabetes; a randomised controlled trial; results after two years' follow-up. BMC Pediatr. 2016 Jul 15;16:94. doi: 10.1186/s12887-016-0632-8.

    PMID: 27421262DERIVED

  • Tiberg I, Carlsson A, Hallstrom I. A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes. Open Nurs J. 2011;5:111-9. doi: 10.2174/18744346011050100111. Epub 2011 Nov 18.

    PMID: 22371819DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Kristian Bolin, PhD

CONTACT

+46 462220654Kristian.Bolin@nek.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

December 1, 2015

Last Updated

December 8, 2008

Record last verified: 2008-12

Locations

SE(2)