Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. A website was developed offering communication with local healthcare professionals, interaction with other patients, and access to relevant information and services. The aim of this study was to look at the use of the website and its effects on young patients with diabetes.
Who can participate?
Families with children and adolescents with diabetes, treated at two paediatric clinics in Sweden.
What does the study involve?
Participating families are randomly allocated to one of two groups. One group receive passwords for access to the website for one year, and the other group do not receive access for 1 year. All families are given access during the second study year. The website was used by patients without directions from healthcare professionals or researchers. We measured how patients used the website. Participants complete questionnaires before the study started and after 1 and 2 years.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Linköping University (Sweden).
When is the study starting and how long is it expected to run for?
April 2006 to September 2008.
Who is funding the study?
The Medical Research Council of Southeast Sweden (FORSS), ALF Grants, County Council of Östergötland, and the Swedish Child Diabetes Foundation.
Who is the main contact?
Dr Sam Nordfeldt
sam.nordfeldt@liu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sam Nordfeldt
ORCID ID
Contact details
Division of Child and Adolescent Psychiatry
Department of Clinical and Experimental Medicine
Linköping University
Linköping
581 85
Sweden
-
sam.nordfeldt@liu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Use of a web 2.0 portal to improve education and communication in young diabetes patients with families: a randomised controlled trial
Acronym
Study hypothesis
A Web 2.0 portal, with diabetes-related information and the possibility to communicate with diabetes peers as well as with health care professionals, would
1. Be of complementary value in everyday life with diabetes, especially by newly diagnosed patients and patients in periods with instable metabolic control
2. Be perceived as helpful in self treatment; and
3. Contribute to improved metabolic control
Ethics approval
Research Ethics Committee of the Faculty of Health Science at Linköping University, Sweden, 04/11/2003
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 1 diabetes
Intervention
The patients and their families were randomised (stratified for clinic) to either the intervention group or the control group.
At baseline April 2006, all subjects in the intervention group were offered a personal password to the portal for the first year of the study. After study year one, all subjects in the previous control group were also offered passwords to the portal. For children 13 years of age and older, both parents and adolescents received passwords while for younger children only parents received passwords. Basic information about the concept was given by posted letters, and informed consent to study participation was required before the first visit.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. HbA1c
2. Number of severe hypoglycaemia incidents
Secondary outcome measures
1. Health-Related Quality Of Life (HRQOL)
2. Empowerment and perception of quality of care regarding information
3. Hypoglycaemia (self-reported) and
4. Numbers of self-controls of blood glucose (self-reported)
5. User activity by site visits and page visits logged per user
Overall trial start date
11/04/2006
Overall trial end date
25/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All the clinically diagnosed type 1 diabetes children registered in the Swedish paediatric diabetes quality registry, SWEDIABKIDS, belonging to the geographic population of the two paediatric clinics in Linköping and Jönköping, were eligible and invited to the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
474
Participant exclusion criteria
1. No consent
2. Transferred to other clinic
Recruitment start date
11/04/2006
Recruitment end date
25/09/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Linköping University
Linköping
581 85
Sweden
Funders
Funder type
Research council
Funder name
The Medical Research Council of Southeast Sweden (FORSS) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ALF Grants, County Council of Östergötland (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Child Diabetes Foundation (Barndiabetesfonden) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23973555
Publication citations
-
Results
Hanberger L, Ludvigsson J, Nordfeldt S, Use of a web 2.0 portal to improve education and communication in young patients with families: randomized controlled trial., J. Med. Internet Res., 2013, 15, 8, e175, doi: 10.2196/jmir.2425.