Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/02/2013
Date assigned
14/02/2013
Last edited
25/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is one of the commonest long term health conditions in the UK, affecting over 2 million adults. Many people with type 2 diabetes need help and support to live a healthy, happy life. The NHS recommends that every person with type 2 diabetes should have the opportunity to attend a self-management course on diabetes when first told they have diabetes, and once a year thereafter. But not everybody who needs these courses gets them – either because there are not enough courses locally, or because the courses are hard to get to, or because patients aren’t offered them. An additional way of helping people with diabetes get the support and information they need to live a healthy, happy life is through the internet. We have developed two websites (one complex; one simple) offering help and support for people with type 2 diabetes. The aims of the study are to see if either website improves people’s wellbeing and clinical outcomes and if they are cost-effective compared to usual care.

Who can participate?
The HeLP-Diabetes study aims to recruit about 400 people with type 2 diabetes, aged 18 years or over from General Practices across England.

What does the study involve?
Participants will be asked to complete a baseline assessment. This involves you completing some questionnaires online and the practice nurse taking some clinical measurements like your height, weight and blood pressure. The nurse will also take a blood sample to measure your HbA1c and cholesterol levels. After this assessment has been completed you will be randomly (by chance) allocated to use one of two websites. One website will be more complicated with lots of online tips and tools to help you manage your diabetes while the other will be simpler; focusing on the essential information everybody with type 2 diabetes needs to know. Half the people in the study will get the complicated website and half will get the simple one, so you have an equal (50:50) chance of getting either one. You will be asked to use the website you have been given as much or as little as you like for 12 months. Your use of the website (number of logins, pages visited) will be automatically recorded by the computer.
After 3 months and 12 months you will be asked to complete the same questionnaires again and to see the practice nurse again to check your blood pressure, weigh you, and to take some blood tests (HbA1c and cholesterol).
At the end of the study, we will compare HbA1c levels and measures of well-being in people asked to use the complicated website versus those asked to use the simpler, information only website.

What are the possible benefits and risks of participating?
Whichever group you are allocated to, you will have the opportunity to use a web-based education site (HeLP-Diabetes) for people with type 2 diabetes for a year. There is some research evidence to show that people who are given diabetes related information have better health outcomes than people who receive no information.
It is very unlikely that you will be at risk as a result of taking part in the study. The information on both websites has been developed by a team of doctors, nurses, dieticians and researchers. It reflects current best practice in the NHS.

Where is the study run from?
University College London in collaboration with The Whittington NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
It is anticipated that General Practice recruitment will start in March 2013 until September 2013. Participant recruitment will then start for another 6 months (September 2013 – March 2014). Participants will be enrolled on the study for one year.

Who is funding the study?
National Institute of Health Research Programme Grant for applied research

Who is the main contact?
Dr Charlotte Dack
c.dack@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Dack

ORCID ID

Contact details

Department of Primary Care and Population Sciences
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
c.dack@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13563

Study information

Scientific title

Randomised controlled trial of a web-based self management programme (HeLP-Diabetes) for people with type 2 diabetes in primary care

Acronym

HeLP-Diabetes

Study hypothesis

We have developed a web-based self-management programme for people with type 2 diabetes (called HeLP-Diabetes). We aim to determine the effectiveness and cost-effectiveness of HeLP-Diabetes through a randomised controlled trial in general practice. Participants will be randomised to using either the HeLP-Diabetes programme or a comparator website (information only). A pilot study will run for 6 months prior to the main RCT.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13563

Ethics approval

Camden and Islington National Research Ethics Committee, 6th December 2012, ref: 12LO1571

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

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 2 diabetes

Intervention

Comparator website, This will be an information only website created by the study team to compare with HeLP-Diabetes

HeLP-Diabetes, HeLP-Diabetes is a web based self-management programme we have developed for adults with type 2 diabetes

Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glycaemic control (HbA1c) and health related quality of life, measured by the Problem Areas in Diabetes (PAID) scale Timepoint(s): Baseline, 3 months, 12 months

Secondary outcome measures

1. Body mass index (BMI); Timepoint(s): Baseline, 3 months, 12 months
2. Completion of "9 essential processes"; Timepoint(s): 12 months
3. Cost of developing intervention; Timepoint(s): Baseline, 3 months, 12 months
4. Cost of supported access; Timepoint(s): Baseline, 3 months, 12 months
5. Costs of maintaining and updating the intervention; Timepoint(s): Baseline, 3 months, 12 months
6. Costs of training NHS staff in using intervention and training patients to use intervention; Timepoint(s): Baseline, 3 months, 12 months
7. Disability Management Self Efficacy Scale (DMSES); Timepoint(s): Baseline, 3 months, 12 months
8. Diabetes Treatment Satisfaction Questionnaire change version (DTSQc); Timepoint(s): 12 months
9. DTSQs; Timepoint(s): Baseline, 3 months, 12 months
10. EQ-5D to calculate Quality-Adjusted Life Years (QALYs); Timepoint(s): Baseline, 3 months, 12 months
11. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): Baseline, 3 months, 12 months
12. Health service utilisation during the study period; Timepoint(s): Baseline, 3 months, 12 months
13. Systolic and diastolic blood pressure; Timepoint(s): Baseline, 3 months, 12 months
14. Total cholesterol and HDL; Timepoint(s): Baseline, 3 months, 12 months
15. Use of website; Timepoint(s): Throughout

Overall trial start date

01/03/2013

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults, male and female, aged 18 or over
2. With type 2 diabetes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 398

Participant exclusion criteria

1. Unable to provide informed consent, e.g. due to psychosis, dementia or severe learning difficulties
2. Terminally ill with less that 12 months life expectancy
3. Unable to use a computer due to severe mental or physical impairment
4. Insufficient mastery of spoken English to use the intervention
5. Current participation in a trial of an alternative self-management programme

Recruitment start date

01/03/2013

Recruitment end date

01/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and Population Sciences
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o Dave Wilson
Joint Research Office (part of the Research Support Centre)
UCL
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
david.wilson@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility; Grant Codes: GZHN

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

Publication citations

Additional files

Editorial Notes