Childhood Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes, Type I
• Intervention / Treatment: Behavioral: childhood diabetes

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian Bolin, PhD; Phone Number: +46 462220654; Email: Kristian.Bolin@nek.lu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41685
    • Recruiting
    • Queen Silvia's Childrens' hospital
    • Contact: Gun Forsander, PhD; Phone Number: +46 31 3438247; Email: Gun.Forsander@vgregion.se
  • Lund, Sweden, 221 00
    • Recruiting
    • Lund University Childrens' hospital
    • Contact: Inger Hallström, PhD, Professor; Phone Number: +46 46 2221896; Email: Inger.Hallstrom@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Outcome Measure: the child's metabolic control as shown in HbA1C	6 months, 1 year, 2 year, 5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vardalinstitutet The Swedish Institute for Health Sciences
• Collaborators: Lund University Hospital; Sahlgren´s University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ANTICIPATED): September 1, 2010
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (ESTIMATE): December 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2008
• Last Update Submitted That Met QC Criteria: December 5, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Diabetes type1; children
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: DiabetesVardal