Diabetes, Type INCT00804232
Childhood Diabetes
A study testing childhood diabetes in people with Diabetes, Type I, run by Vardalinstitutet The Swedish Institute for Health Sciences at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Diabetes, Type I
- What is being tested?
- childhood diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Queen Silvia's Childrens' hospital
Gothenburg, 41685
Gun Forsander, PhD, +46 31 3438247, Gun.Forsander@vgregion.se
- Recruiting
Lund University Childrens' hospital
Lund, 221 00
Inger Hallström, PhD, Professor, +46 46 2221896, Inger.Hallstrom@med.lu.se
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Diabetes, Type I
- Being tested
- childhood diabetes
- Keywords
- Diabetes type1; children
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
childhood diabetesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | effects on child health of family-based home care compared to traditional hospital-based care, Receives: Behavioral: childhood diabetes |
| 2 | Experimental | effects on child health of family-based psychological treatment compared to traditional hospital-based treatment Receives: Behavioral: childhood diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: the child's metabolic control as shown in HbA1C
Measured: 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
Measured: 6 months, 1 year, 2 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2010 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes, Type IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804232
- Sponsor's protocol ID
- DiabetesVardal
- Status last verified
- Dec 2008
- First submitted
- 5 Dec 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27421262Tiberg 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.
PubMed 22371819
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Diabetes - Family Based Health Interventions for Child Health
- ClinicalTrials.gov ID
- NCT00804232
- Acronym / sponsor ID
- DiabetesVardal
- Conditions
- Diabetes, Type I
- Keywords
- Diabetes type1; children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Collaborators
- Lund University Hospital, Sahlgrenska University Hospital
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: childhood diabeteseffects on child health of family-based home care compared to traditional hospital-based care, |
| 2 | Experimental | Behavioral: childhood diabeteseffects on child health of family-based psychological treatment compared to traditional hospital-based treatment |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children, aged 3 - 15
- newly diagnosed with diabetes mellitus
- no other chronic illnesses
- Swedish as mother tongue
- no siblings with type 1 diabetes
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| childhood diabetesthe 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. | Behavioural | 1, 2 |
Primary outcome
Primary Outcome Measure: the child's metabolic control as shown in HbA1C
Time frame: 6 months, 1 year, 2 year, 5 year
1 secondary outcome
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
Time frame: 6 months, 1 year, 2 year, 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
- Derived from this study: PubMed 27421262Tiberg 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.
- Derived from this study: PubMed 22371819Tiberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing childhood diabetes in people with Diabetes, Type I, run by Vardalinstitutet The Swedish Institute for Health Sciences at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian Bolin, PhD (+46 462220654, Kristian.Bolin@nek.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: the child's metabolic control as shown in HbA1C (time frame: 6 months, 1 year, 2 year, 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804232, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2008.