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

D Morrison; S Wyke; K Saunderson; A McConnachie; K Agur; R Chaudhuri; M Thomas; N C Thomson; L Yardley; F S Mair

doi:10.1136/bmjopen-2015-009254

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

D Morrison, S Wyke, K Saunderson, A McConnachie, K Agur, R Chaudhuri, M Thomas, N C Thomson, L Yardley, F S Mair

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Abstract

OBJECTIVE: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (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≥16 years) 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 postrandomisation was not possible.

RESULTS: Recruitment target met. 51 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. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 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.

TRIAL REGISTRATION NUMBER: ISRCTN78556552; Results.

Original language	English
Article number	e009254
Number of pages	10
Journal	BMJ Open
Volume	6
Issue number	5
DOIs	https://doi.org/10.1136/bmjopen-2015-009254
Publication status	Published - 12 May 2016

Keywords

Adolescent
Adult
Aged
Anti-Inflammatory Agents/administration & dosage
Asthma/drug therapy
Bronchodilator Agents/administration & dosage
Exercise
Feasibility Studies
Female
Humans
Internet/statistics & numerical data
Male
Medication Adherence
Middle Aged
Patient Selection
Pilot Projects
Prednisolone/administration & dosage
Quality of Life
Self Care
Surveys and Questionnaires
Young Adult

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@article{0becd56715f245cdb0dcd507bad646ff,

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

abstract = "OBJECTIVE: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (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≥16 years) 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 postrandomisation was not possible.RESULTS: Recruitment target met. 51 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. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 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.TRIAL REGISTRATION NUMBER: ISRCTN78556552; Results.",

keywords = "Adolescent, Adult, Aged, Anti-Inflammatory Agents/administration & dosage, Asthma/drug therapy, Bronchodilator Agents/administration & dosage, Exercise, Feasibility Studies, Female, Humans, Internet/statistics & numerical data, Male, Medication Adherence, Middle Aged, Patient Selection, Pilot Projects, Prednisolone/administration & dosage, Quality of Life, Self Care, Surveys and Questionnaires, Young Adult",

author = "D Morrison and S Wyke and K Saunderson and A McConnachie and K Agur and R Chaudhuri and M Thomas and Thomson, {N C} and L Yardley and Mair, {F S}",

year = "2016",

month = may,

day = "12",

doi = "10.1136/bmjopen-2015-009254",

language = "English",

volume = "6",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "5",

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TY - JOUR

T1 - Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)

AU - Morrison, D

AU - Wyke, S

AU - Saunderson, K

AU - McConnachie, A

AU - Agur, K

AU - Chaudhuri, R

AU - Thomas, M

AU - Thomson, N C

AU - Yardley, L

AU - Mair, F S

PY - 2016/5/12

Y1 - 2016/5/12

N2 - OBJECTIVE: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (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≥16 years) 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 postrandomisation was not possible.RESULTS: Recruitment target met. 51 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. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 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.TRIAL REGISTRATION NUMBER: ISRCTN78556552; Results.

AB - OBJECTIVE: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (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≥16 years) 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 postrandomisation was not possible.RESULTS: Recruitment target met. 51 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. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 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.TRIAL REGISTRATION NUMBER: ISRCTN78556552; Results.

KW - Adolescent

KW - Adult

KW - Aged

KW - Anti-Inflammatory Agents/administration & dosage

KW - Asthma/drug therapy

KW - Bronchodilator Agents/administration & dosage

KW - Exercise

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Internet/statistics & numerical data

KW - Male

KW - Medication Adherence

KW - Middle Aged

KW - Patient Selection

KW - Pilot Projects

KW - Prednisolone/administration & dosage

KW - Quality of Life

KW - Self Care

KW - Surveys and Questionnaires

KW - Young Adult

U2 - 10.1136/bmjopen-2015-009254

DO - 10.1136/bmjopen-2015-009254

M3 - Article (Academic Journal)

C2 - 27173807

SN - 2044-6055

VL - 6

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e009254

ER -

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

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