Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/11/2011
Date assigned
10/02/2012
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

Landstinget i Ostergotland
Linkoping
581 91
Sweden

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23973555

Publication citations

  1. 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.

Additional files

Editorial Notes