Childhood Diabetes - Family Based Health Interventions for Child Health
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 210
- Locations
- 4
- Primary Endpoint
- Primary Outcome Measure: the child's metabolic control as shown in HbA1C
Study Overview
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:
- 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.
Detailed Description
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:
(3) to analyse the effects on child health of family-based home care compared to traditional hospital-based care, and (4) to analyse the effects on child health of family-based psychological treatment compared to traditional hospital-based treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
2
effects on child health of family-based psychological treatment compared to traditional hospital-based treatment
Intervention: childhood diabetes (Behavioral)
1
effects on child health of family-based home care compared to traditional hospital-based care,
Intervention: childhood diabetes (Behavioral)
Outcomes
Primary Outcomes
Primary Outcome Measure: the child's metabolic control as shown in HbA1C
Time Frame: 6 months, 1 year, 2 year, 5 year
Secondary Outcomes
- 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)