Diabetes, Type I Clinical Trial
Official title:
Childhood Diabetes - Family Based Health Interventions for Child Health
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.
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.
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.
Methods:
Design:
The study is planned to include four parts: one historical control group including data for
metabolic control from the Swedish diabetes register for children (SWEDIABKIDS), two
randomised controlled trials at two different university hospitals in Sweden (Lund and
Gothenburg), and one prospective control group at one region hospitals (Helsingborg). Data
will be collected at inclusion and after six, 12 and 24 months after diagnosis. We plan a
longitudinal follow-up five and ten year after diagnosis concerning metabolic control and
complications.
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.
Analysis:
The main analysis is that of the differences in child health (main variable: HbA1c) between
intervention and control groups. Analysis of variance (ANOVA) will be applied.
Instruments and data:
Metabolic control:
P-glucos (self-monitoring) during the first two years. Weekly random chosen twenty-four hour
graph. HbA1c monthly during the first two years. From this a yearly mean HbA1c is
established.
Reports according to SWEDIABKIDS/NDRBarn: for example weight, length, BMI, insulin (time,
dose, type), blood pressure, U-albumin, severe hypoglucaemia, and cetoacidosis, number of
hospitalisations.
Background variables:
Age, civil status, number of persons in the family, education, occupation, level of
employment.
Quality of life, well-being, and health:
PedsQL Generic Core Scales, Child self-report (Adolescent 13-18 years, Child 8-12 years),
Young Child, Parent proxy report (5-7 years) (Varni & PedsMetrics/The PedsQL™)..
PedsQL, Diabetes module (Varni & PedsMetrics/The PedsQL™). Children 8-18 years, parents
proxy report (children 5-7 years).
SF 36, Health Utility Index. Satisfaction with care PedsQL, Health Care Satisfaction Generic
Module. Parents. (Varni & PedsMetrics/The PedsQL™).
Family impact and family climate The PedsQLTM Family Impact Module. Parents. Physical,
emotional, social and cognitive function, communikation, anxiety, daily activities, and
family relations. (Varni & PedsMetrics/The PedsQL™).
Diabetes Family Behavior Scale.
Diabetes Family Conflict:
Family climate. Shows changes from therapeutic interventions (Hansson, 1991). Mastery.
(Pearlin, Menaghan, Lieberman & Mullan, 1981). Controll in daily life and the possibility to
achive individual goals.
THU-5, (Targeting Hassles and Uplifts- five items, Erlandsson & Eklund, 2003). Parents
experiences of hassles and uplifts in daily life.
THU-3 (Targeting Hassles and Uplifts- three items) Costs of social welfare-during and after
the initial hospitalisation Hospital costs during hospitalisation. Professionals' time use
which is conditional on the child's diabetes for the different regiments.
Number and time for out patient visits/home visits. Number and time for telephone contacts.
Psychosocial Assessment:
Psychosocial Assessment Tool, (The Children's hospital of Philadelphia, Division of
Oncology, 2004) meassure psychosocial variables, family interplay, and family function.
Absenteeism from work and school Familjens diabetesrelaterade frånvaro från arbete och skola
Parental and child's absenteeism from work and school related to the diabetes. 12 och 24
mån.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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