Use of a web 2.0 portal to improve education and communication in young diabetes patients with families

ISRCTN ISRCTN92107365
DOI https://doi.org/10.1186/ISRCTN92107365
Secondary identifying numbers N/A
Submission date
25/11/2011
Registration date
10/02/2012
Last edited
08/12/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Sam Nordfeldt
Scientific

Division of Child and Adolescent Psychiatry
Department of Clinical and Experimental Medicine
Linköping University
Linköping
581 85
Sweden

Email sam.nordfeldt@liu.se

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleUse of a web 2.0 portal to improve education and communication in young diabetes patients with families: a randomised controlled trial
Study objectivesA 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(s)Research Ethics Committee of the Faculty of Health Science at Linköping University, Sweden, 04/11/2003
Health condition(s) or problem(s) studiedType 1 diabetes
InterventionThe 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 typeOther
Primary outcome measure1. HbA1c
2. Number of severe hypoglycaemia incidents
Secondary outcome measures1. 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 study start date11/04/2006
Completion date25/09/2008

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants474
Key inclusion criteriaAll 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
Key exclusion criteria1. No consent
2. Transferred to other clinic
Date of first enrolment11/04/2006
Date of final enrolment25/09/2008

Locations

Countries of recruitment

  • Sweden

Study participating centre

Linköping University
Linköping
581 85
Sweden

Sponsor information

County Council of Östergötland (Landstinget i Ostergotland) (Sweden)
Government

Landstinget i Ostergotland
Linkoping
581 91
Sweden

ROR logo "ROR" https://ror.org/0326gsy75

Funders

Funder type

Research council

The Medical Research Council of Southeast Sweden (FORSS) (Sweden)

No information available

ALF Grants, County Council of Östergötland (Sweden)

No information available

The Swedish Child Diabetes Foundation (Barndiabetesfonden) (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/08/2013 Yes No