Condition category
Respiratory
Date applied
16/04/2013
Date assigned
18/06/2013
Last edited
16/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with asthma often put up with symptoms such as wheeze, shortness of breath or interrupted sleep without realising that adjusting their inhalers might help. Some studies have shown that people with asthma have fewer symptoms when they use online resources to learn about asthma and to receive feedback about their symptoms and medications. We have developed such a resource which will be available free of charge to people with asthma. Before it can be made widely available we need to find out how it works in practice, so we are trying it out in this study. We want to find out how the website is used so we can learn ways to improve it.

Who can participate?
Adults over the age of 16, with a diagnosis of asthma and an ACQ (Asthma Control Questionnaire ) score greater than or equal to 1, can participate.

What does the study involve?
We will randomly allocate people into one of two groups: one group will get to use the website for 12 weeks and the other group will manage their asthma as normal. There will be a follow-up, 12 weeks after the first visit, covering similar areas as the first visit and to check lung function. Those who didn’t have a login for the website will be given one then for 12 weeks. We also want to interview some people for their feed about using the website. This interview will take less than 60 minutes and is optional.

What are the possible benefits and risks of participating?
The benefits are that the participants will learn about their condition and may gain better control of their asthma, resulting in fewer symptoms. As long as participants continue to seek advice from their doctor or nurse as usual, we do not see any risks to any individuals taking part in this study.

Where is the study run from?
This study has been set up and will be run by the University of Glasgow, sponsored by NHS Greater Glasgow and Clyde.

When is study starting and how long is it expected to run for?
The study starts in June 2013 and will run until November 2014. The study will be recruiting participants for 6 months and the participants will be in the study for a maximum of 5 months (3 months using the online resource and 2 months to participate in a qualitative interview).

Who is funding the study?
This project is funded by the Chief Scientist Office, Scottish Government (reference CAF/11/08).

Who is the main contact?
Dr Deborah Morrison
Deborah.morrison@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Deborah Morrison

ORCID ID

Contact details

1 Horselethill Road
General Practice & Primary Care
Institute of Health & Wellbeing
University of Glasgow
Glasgow
G12 9LX
United Kingdom
01413308383
deborah.morrison@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RAISINV2.0

Study information

Scientific title

A pilot Randomised controlled trial (RCT) of Asthma Internet Self management INtervention

Acronym

RAISIN

Study hypothesis

Current hypothesis as of 13/02/2014:
This pilot RCT aims to establish:
1. Recruitment and retention rates
2. Provide estimates of efficacy across a range of outcomes in order to estimate effect sizes for future full scale evaluations
3. Usability of this online resource

We hypothesise that this online resource, which has been designed with end user involvement and aims to improve adherence to therapy using multiple strategies, will result in improved symptom control and asthma quality of life.

Previous hypothesis:
This pilot RCT aims to establish:
1. Recruitment and retention rates
2. Feasibility of selected outcome measures (clinical and process)
3. Usability of this online resource. This pilot study does not aim to show changes in outcome measures.

Ethics approval

West of Scotland Research Ethics Committee, 19/03/2013, WOS/13/0004

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Asthma self management

Intervention

Participants are randomised to two groups:
1. One group receives an internet-based resource which aims to promote adherence to asthma treatments by challenging negative beliefs, promoting activation, recognising barriers, using goalsetting, and providing information, leading to improvements in symptoms control and quality of life.
2. Other group manages asthma as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 13/02/2014:
1. Recruitment and retention rates at 12 weeks from baseline
2. Web use over 12 weeks (via automatically collected counts of access to website) plus perceived barriers and facilitators to sustained use of resource (via qualitative evaluation)
3. Changes at 12 weeks from baseline for:
3.1. Asthma Control Questionnaire (ACQ)
3.2. Asthma Quality of Life Questionnaire (AQLQ)

Previous primary outcome measures:
1. Recruitment and retention rates at 12 weeks from baseline
2. Web use over 12 weeks (via automatically collected counts of access to website) plus perceived barriers and facilitators to sustained use of resource (via qualitative evaluation)

Secondary outcome measures

Current secondary outcome measures as of 13/02/2014:
1. Changes at 12 weeks from baseline for
1.1. EQ-5D3
1.2. Patient Activation Measure (PAM)
1.3. Morisky Medication Adherence Scale (MMAS)
1.4. Lung function (via pre bronchodilator spirometry)
1.5. Airway inflammation (via fractional exhaled nitric oxide)
2. Problematic Experiences of Therapy Scale (PETS) in those in intervention group at follow up visit only (at 12 weeks)
3. Self-reported health care utilisation
4. Self-reported medication utilisation
5. Adverse events

Previous secondary outcome measures:
1. Changes at 12 weeks from baseline for:
1.1. Asthma Control Questionnaire (ACQ)
1.2. Asthma Quality of Life Questionnaire (AQLQ)
1.3. EQ-5D3
1.4. Patient Activation Measure (PAM)
1.5. Morisky Medication Adherence Scale (MMAS)
1.6. Lung function (via pre bronchodilator spirometry)
1.7. Airway inflammation (via fractional exhaled nitric oxide)
2. Problematic Experiences of Therapy Scale (PETS) in those in intervention group at follow up visit only (at 12 weeks)
3. Self-reported health care utilisation
4. Self-reported medication utilisation
5. Adverse events

Overall trial start date

01/06/2013

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Age 16 years or older
3. Diagnosis of asthma by a health professional and duration of asthma symptoms for more than 1 year
4. Juniper ACQ score ≥ 1
5. Ability to access the internet

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Unstable asthma
2. Presence of active lung disease other than asthma
3. Mental impairment/language difficulties making informed consent impossible
4. Terminal illness
5. Cognitive impairment

Recruitment start date

23/09/2013

Recruitment end date

31/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

1 Horselethill Road
Glasgow
G12 9LX
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

c/o Dr Maureen Travers
The Tennent Institute
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
+44 141 211 6389
maureen.travers@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office, Scottish Goverment (UK), Ref: CAF/11/08

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884722
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27173807

Publication citations

  1. Protocol

    Morrison D, Wyke S, Thomson NC, McConnachie A, Agur K, Saunderson K, Chaudhuri R, Mair FS, A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial., Trials, 2014, 15, 185, doi: 10.1186/1745-6215-15-185.

  2. Results

    Morrison D, Wyke S, Saunderson K, McConnachie A, Agur K, Chaudhuri R, Thomas M, Thomson NC, Yardley L, Mair FS, Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN), BMJ Open, 2016, 6, 5, e009254, doi: 10.1136/bmjopen-2015-009254.

Additional files

Editorial Notes

16/05/2016: Publication reference added. 04/11/2015: The recruitment start date has been updated from 01/06/2013 to 23/09/2013 at the request of the trialist.