A Randomized Trial of an Asthma Internet Self-management Intervention (RAISIN): Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2014 Jun 3

PMID 24884722

Citations 6

Authors

Deborah Morrison

Sally Wyke

Neil C Thomson

Alex McConnachie

Karolina Agur

Kathryn Saunderson

Rekha Chaudhuri

Frances S Mair

Affiliations

Soon will be listed here.

Abstract

Background: The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.

Methods/design: The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).

Discussion: Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.

Trial Registration: This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Citing Articles

Gamification and Adherence to Web-Based Mental Health Interventions: A Systematic Review.

Brown M, ONeill N, Van Woerden H, Eslambolchilar P, Jones M, John A JMIR Ment Health. 2016; 3(3):e39.

PMID: 27558893 PMC: 5014987. DOI: 10.2196/mental.5710.

Home telemonitoring and remote feedback between clinic visits for asthma.

Kew K, Cates C Cochrane Database Syst Rev. 2016; (8):CD011714.

PMID: 27486836 PMC: 7433298. DOI: 10.1002/14651858.CD011714.pub2.

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

Morrison D, Wyke S, Saunderson K, McConnachie A, Agur K, Chaudhuri R BMJ Open. 2016; 6(5):e009254.

PMID: 27173807 PMC: 4874112. DOI: 10.1136/bmjopen-2015-009254.

Remote versus face-to-face check-ups for asthma.

Kew K, Cates C Cochrane Database Syst Rev. 2016; 4:CD011715.

PMID: 27087257 PMC: 8407490. DOI: 10.1002/14651858.CD011715.pub2.

Details of development of the resource for adults with asthma in the RAISIN (randomized trial of an asthma internet self-management intervention) study.

Morrison D, Mair F, Chaudhuri R, McGee-Lennon M, Thomas M, Thomson N BMC Med Inform Decis Mak. 2015; 15:57.

PMID: 26215651 PMC: 4517557. DOI: 10.1186/s12911-015-0177-z.

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