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Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)

Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)
Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)
Objective: To evaluate the feasibility of a Phase 3 randomised controlled trial (RCT) of a web-site (Living Well with Asthma) to support self-management.

Design and Setting: Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.

Participants: Adults (age ? 16rs) with physician diagnosed, symptomatic asthma (asthma control questionnaire (ACQ) score ? 1). People with unstable asthma or other lung disease were excluded.

Intervention: ‘Living Well with Asthma’ is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.

Outcome measures: Primary outcomes were recruitment/retention, website use, ACQ and mini asthma quality of life questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation, and health service contacts after 12 weeks. Blinding post-randomisation was not possible.

Results: Recruitment target met. Fifty one participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%) (20 intervention group) followed up. Nineteen (76% of the intervention group) used the website, for a mean of 18 minutes, (range 0,49). Seventeen went beyond the two ‘core’ modules. Median number of logins was 1 (interquartile range 1,2, range 0,7). No significant difference in the pre-specified primary efficacy measures of ACQ scores (-0.36; 95% confidence interval: -0.96, 0.23; p=0.225), and mini-AQLQ scores (0.38;-0.13, 0.89; p=0.136). No adverse events.

Conclusions: Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a Phase 3 trial.
Current Controlled Trials – ISRCTN78556552
1-11
Morrison, D.
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Wyke, S.
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Sauderson, K.
96fa560f-0d49-4743-aca7-62c8f3769efa
McConnachie, A.
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Agur, K.
87720160-c50b-4654-bdcf-656f65f4c2d0
Chaudhuri, R.
43513d7c-0168-4f11-b188-f3d2f0e596cb
Thomas, M.
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Thomson, N.
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Yardley, L.
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Mair, F.S.
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Morrison, D.
1e1151d0-a55a-401a-a47d-7ea0068fb447
Wyke, S.
65b17997-94a6-44ea-9b43-efc5bf308f58
Sauderson, K.
96fa560f-0d49-4743-aca7-62c8f3769efa
McConnachie, A.
763c8776-b584-441c-a7b4-af068e1f0ef9
Agur, K.
87720160-c50b-4654-bdcf-656f65f4c2d0
Chaudhuri, R.
43513d7c-0168-4f11-b188-f3d2f0e596cb
Thomas, M.
997c78e0-3849-4ce8-b1bc-86ebbdee3953
Thomson, N.
919a6f46-12dd-4ba3-ae8b-6e486ca48f5f
Yardley, L.
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Mair, F.S.
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Morrison, D., Wyke, S., Sauderson, K., McConnachie, A., Agur, K., Chaudhuri, R., Thomas, M., Thomson, N., Yardley, L. and Mair, F.S. (2016) Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN). BMJ Open, 6 (e009254), 1-11. (doi:10.1136/bmjopen-2015-009254). (PMID:27173807)

Record type: Article

Abstract

Objective: To evaluate the feasibility of a Phase 3 randomised controlled trial (RCT) of a web-site (Living Well with Asthma) to support self-management.

Design and Setting: Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.

Participants: Adults (age ? 16rs) with physician diagnosed, symptomatic asthma (asthma control questionnaire (ACQ) score ? 1). People with unstable asthma or other lung disease were excluded.

Intervention: ‘Living Well with Asthma’ is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.

Outcome measures: Primary outcomes were recruitment/retention, website use, ACQ and mini asthma quality of life questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation, and health service contacts after 12 weeks. Blinding post-randomisation was not possible.

Results: Recruitment target met. Fifty one participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%) (20 intervention group) followed up. Nineteen (76% of the intervention group) used the website, for a mean of 18 minutes, (range 0,49). Seventeen went beyond the two ‘core’ modules. Median number of logins was 1 (interquartile range 1,2, range 0,7). No significant difference in the pre-specified primary efficacy measures of ACQ scores (-0.36; 95% confidence interval: -0.96, 0.23; p=0.225), and mini-AQLQ scores (0.38;-0.13, 0.89; p=0.136). No adverse events.

Conclusions: Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a Phase 3 trial.
Current Controlled Trials – ISRCTN78556552

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More information

Accepted/In Press date: 21 April 2016
e-pub ahead of print date: 12 May 2016
Published date: 12 May 2016
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 394841
URI: https://eprints.soton.ac.uk/id/eprint/394841
PURE UUID: c017f3c7-420e-4565-9f48-41be324d965b
ORCID for L. Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 24 May 2016 14:44
Last modified: 20 Jul 2019 01:11

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