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Living well with asthma: supporting self care
ISRCTN ISRCTN78556552
DOI 10.1186/ISRCTN78556552
ClinicalTrials.gov identifier
EudraCT number
Public title Living well with asthma: supporting self care
Scientific title A pilot Randomised controlled trial (RCT) of Asthma Internet Self management INtervention
Acronym RAISIN
Serial number at source RAISINV2.0
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.
Lay 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 didnít 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
Ethics approval West of Scotland Research Ethics Committee, 19/03/2013, WOS/13/0004
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Asthma self management
Participants - 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
Participants - 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
Anticipated start date 01/06/2013
Anticipated end date 31/10/2014
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 50
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Chief Scientist Office, Scottish Goverment (UK), Ref: CAF/11/08
Trial website
Publications 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884722
Contact name Dr  Deborah  Morrison
  Address 1 Horselethill Road
General Practice & Primary Care
Institute of Health & Wellbeing
University of Glasgow
  City/town Glasgow
  Zip/Postcode G12 9LX
  Country United Kingdom
  Tel 01413308383
  Email deborah.morrison@glasgow.ac.uk
Sponsor NHS Greater Glasgow & Clyde (UK)
  Address c/o Dr Maureen Travers
The Tennent Institute
Western Infirmary
38 Church Street
  City/town Glasgow
  Zip/Postcode G11 6NT
  Country United Kingdom
  Email maureen.travers@ggc.scot.nhs.uk
Date applied 16/04/2013
Last edited 03/06/2014
Date ISRCTN assigned 18/06/2013
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