Childhood Diabetes

Childhood Diabetes - Family Based Health Interventions for Child Health

Sponsors

Lead Sponsor: Vardalinstitutet The Swedish Institute for Health Sciences

Collaborator: Lund University Hospital
Sahlgren´s University Hospital

Source Vardalinstitutet The Swedish Institute for Health Sciences
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. 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.

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.

Overall Status Unknown status
Start Date January 2008
Completion Date December 2015
Primary Completion Date September 2010
Phase N/A
Study Type Interventional
Primary 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
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
Enrollment 210
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: childhood diabetes

Description: 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.

Eligibility

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:

-

Gender: All

Minimum Age: 3 Years

Maximum Age: 15 Years

Healthy Volunteers: No

Overall Contact

Last Name: Kristian Bolin, PhD

Phone: +46 462220654

Email: [email protected]

Location
Facility: Status: Contact:
Queen Silvia's Childrens' hospital | Gothenburg, 41685, Sweden Recruiting Gun Forsander, PhD +46 31 3438247 [email protected]
Lund University Childrens' hospital | Lund, 221 00, Sweden Recruiting Inger Hallström, PhD, Professor +46 46 2221896 [email protected]
Location Countries

Sweden

Verification Date

December 2008

Responsible Party

Name Title: principal investigators: inger Hallsgtröm; Gun Forsander

Organization: Inger Hallstrom, Lund University; Gun Forsander, Sahlgrenska University Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

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

Label: 2

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov