Around 300 million people worldwide currently suffer from asthma [1]. The mortality caused by asthma is significant since a global estimation attributes to this disease about 1 in every 250 deaths [1]. Living with asthma is also difficult. People with asthma report worse health and quality of life than those without asthma [2,3].

Solutions have been developed to help people with asthma cope with their condition [4]. One of the key elements to optimal asthma management is to achieve good control of the disease. To achieve that, patients’ knowledge in recognizing asthma symptoms, identifying risk factors, using medication, and managing asthma exacerbations is important. Further, the relationship between patients with asthma and healthcare providers is crucial to develop an efficient asthma self-management plan [5].

One of the most useful tools in facilitating effective asthma self-management is the use of an individualized written asthma action plan, which describes different tailored steps of actions for the patient to follow according to their asthma severity. Written asthma action plans are claimed to be one of the most effective means for asthma self-management in several systematic reviews [6-8]. A Cochrane review by Gibson and colleagues concludes that use of a written asthma action plan, combined with regular visits to the doctor and education about asthma, leads to fewer visits to the emergency department, less hospital admissions, better lung function, and improvement on symptoms [6]. Online social networks and personal health management systems represent an innovative intervention to help patients engage with clinicians, health services, and self-management [9]. Despite strong evidence for the efficacy of written asthma action plans, they are widely under-used. Even after over 20 years of recommendation, only about one in 5 people with asthma have a written asthma action plan [10].

In Australia, the prevalence of asthma is particularly high and represents one of the highest in the world [2,3]. More than 1 in 10 adults and children is estimated to be suffering from asthma, representing more than 2 million Australians [2]. Although prevalence of asthma has declined over the last decade, the mortality caused by this disease remains significant with 411 people reported to have died from asthma in 2009 in Australia. According to a survey from the Australian Council of Asthma Monitoring in 2007 and 2008, only 21.3% of all-age patients with asthma are reported to possess a written asthma action plan [2,3]. This rate dropped to 14.4% when considering a subgroup of people aged 15 years and over [2].

There are a number of explanations for the under-usage of written asthma action plans by patients. Firstly, the diagnosis of asthma may not have been made in primary care where symptoms have been treated, if the disease is not labeled then patients may not be provided with long-term self-management tools [11]. When asthma is properly diagnosed, some health professionals provide patients with oral instruction instead of a formal written asthma action plan [12]. Others may consider asthma action plans as inefficient tools because of a lack of information and a difference of perception of asthma between patients and doctors [13,14]. From the patient’s point-of-view, asthma action plans can also be perceived as irrelevant or be under-used because of a passive attitude toward their asthma. This can prevent them from taking personal control of their asthma [15,16]. Finally, another reason could be that patients do not visit healthcare professionals to obtain or to update their asthma action plan, or do not ask for it when they see their general practitioner [15].

For asthma, Internet-based self-management appears to be a promising approach to improve control of this condition [17-21]. The aim of this study is to test a Web-based personally controlled health management system (PCHMS), in supporting consumers with asthma to encourage the uptake and use of a personal written asthma action plan, and to proactively seek self-management advice and schedule planned general practitioner (GP) visits before experiencing an asthma exacerbation. The PCHMS, called Healthy.me, has been previously tested with patients undergoing in-vitro fertilization (IVF) [22], in a randomized controlled trial to improve uptake of influenza vaccination [23,24], and amongst university students about help-seeking behaviors for physical and emotional well-being [25,26].

Specific hypotheses to be tested in this study are that:

A randomized controlled trial with a 2-group parallel design (with intervention allocation ratio 1:1) will be used to evaluate the efficacy of the Web-based PCHMS Healthy.me, reported in accordance to the 2010 CONSORT statements [27](ACTRN12612000716864). The PCHMS is not part of usual care but aims to improve usual care as measured by compliance to evidence-based guidelines.

Participants meeting eligibility criteria will be invited to use Healthy.me for 12 months. Participants will be assigned to intervention (access to Healthy.me) or control (access to static website) by random allocation generated by a computerized random-number generator [28]. Participants may be randomly selected to attend a 1-hour interview (or focus group) to discuss their asthma management and feedback at the end of the study. The participant inclusion eligibility criteria are as follows: (1) aged 18 or above, (2) living in Australia at the time of the study, (3) easy access to the Internet and email on a regular basis, (4) doctor diagnosis of asthma, and (5) adequate English reading and written ability. Participants currently enrolled in other trials of Healthy.me are excluded.

All participant volunteers responding to the invitation are required to register online by providing consent, completing a 3-minute eligibility questionnaire. Those eligible will then be invited to complete a 10-minute online pre-study survey and to watch a 3-minute online tutorial about Healthy.me. All eligible participants will also complete a 5-minute monthly survey during the study and a 10-minute post-study survey at 12 months. The control and intervention arms of the trial run concurrently, meaning that the randomly allocated participants of the trial will be exposed to the same environmental condition (eg, season), and the same background of public health campaigns.

A conservative estimate of at least 300 participants with 150 in each arm is needed to detect a 15% point difference in possession rate of a written asthma action plan between the control group (14.4%) and the intervention group (29.4%). This estimate is calculated at 5% level of significance, 80% power (2-sided test), with an anticipated participant dropout rate approximately 25%.

The effect size estimate is based on previous studies using Healthy.me assessing the efficacy of Internet-based interventions on the uptake of preventative health actions [23], and on studies with interventions promoting the use of personal asthma action plans [13]. The base rate is the percentage of adults (ie, 15 years and over) with current asthma in Australia and possessing a written asthma action plan, reported in the Australia Centre for Asthma Monitoring analysis of the Australian Bureau of Statistics National Health Survey 2007-2008, and cited in the Australia Centre for Asthma Monitoring 2011 report [2].

The primary measure is the number of participants who have obtained, or have updated, their written asthma action plan with a GP within the 12 months of the study. The secondary outcomes concern actual use rate of the written asthma action plan, number of unplanned visit to healthcare for asthma, usage of Healthy.me, asthma symptoms, and competing demands on health and asthma. Please see Table 1 below.

Firstly, self-reported responses are collected by use of Internet-based survey, accessed online, or sent to participants via email (Table 2). Surveys will be hosted by “KeySurvey”, an in-house survey infrastructure available at UNSW [33]. All completed responses will be stored securely in a server managed by UNSW. These surveys are:

Secondly, during the study, participants’ actions on the Healthy.me system will be unobtrusively and automatically logged.

Thirdly, a subset of participants (up to 10% of the sample) may be selected, according to their experiences and their patterns of behaviors using Healthy.me, for a post-study semi-structured interview/focus group, eliciting their feedback on Healthy.me and asthma self-management.

Statistical significance is defined as a P-value of less than .05 (determined using a two-tailed test). Data will be collected by online survey software KeySurvey [33] and analyzed using IBM SPSS Statistics 19 [34].

Table 3 below summarizes participant procedures in the study. The duration of the study is expected to be 12 months.

Email will be the primary channel to communicate with participants for study information and reminders about survey completion. From the time participants are recruited until study completion, all participants (control and intervention) will receive an email each month to complete a 5-minute survey about their health in the past month. At study completion, all participants will receive an email asking them to complete a post-study survey. In order to ensure the completeness of data collection, there will be 2 follow-up emails sent 5 days apart from each other to remind those who have not completed each survey.

There are several potential limitations in this study. Firstly, the number of participants meeting inclusion criteria at study completion might be low because the study will focus recruitment only in Australia. The other inclusion criteria such as age, Internet access, and English speaking skills, might be also restrictive for recruiting participant in the targeted population.

Secondly, there is a possible high attrition rates. The study’s outcomes will rely on data from participants’ self-reports. Due to the long duration of the study, over 12 months, it is possible to observe a high rate of attrition from participants and thus, a significant loss of data. To limit this, all participants will be actively requested to complete questionnaires by receiving monthly reminders via emails. Furthermore, the questionnaires used on a monthly-basis will be easy and convenient complete (short questionnaires with an online completion using multiple-choice questions).

Thirdly, there may not be representative of consumers with asthma. The study may be more appealing to younger participants who are interested or literate in computers, the Internet, or asthma self-management topics. These participants may be more enthusiastic about health and the Internet than the general asthma population.

Fourthly, as this is a pragmatic trial of a multifaceted intervention in a complex environment, it is possible that baseline variables associated with participants might also influence the outcome. For example, having a prior history of obtaining a written asthma action plan may predict future planned visits to GP, independent of any additional intervention. We will identify potential baseline variables that might influence outcomes, including age and smoking status, and test for unequal variance in the distribution of these variables in the intervention and control populations.

Most of the features used in the study have been recently tested in a Healthy.me trial on help-seeking behaviors for physical and emotional well-being in a university student population [25]. The results of that study have shown that some bundles of features could lead to behavioral changes in university health service utilization and reported help-seeking for physical and/or emotional concerns. These results were consistent with theoretical expectations of behavioral changes generated from the use of features in Healthy.me. Particularly, the Health Belief Model (HBM) provides insights on how information may be transformed into action when informational cues in the environment are linked to action [41]. In the present study, we expect that the use of the online appointment booking service will be significantly associated with visits to health professionals, and consequently with a high rate in obtaining an asthma action plan. Another lever of behavioral change in accord with the principle of self-monitoring, may be operate thanks to features which encourage self-refection and self-awareness, such as the Personal Health Record, the Pillbox, the Diary, and the Poll [42]. In addition, the social and interactive features used in Healthy.me (Forums, Poll, Message) should play an important role in minimizing attrition and in promoting utilization of the platform amongst participants during the 12 months of the study [9].

Our design of the present randomized controlled trial (RCT) focuses on the comparison of outcomes that unequivocally reflect a change in consumer behavior, and takes into account the complexity of intervention. Results of this study will offer new insights about the utility of a Personally Controlled Health Management System (PCHMS) for consumer engagement with e-health services and self-management. Our findings will provide specific answers to whether using a Web-based PHCMS, containing information and self-management tools that facilitate consumers to engage with health services, will improve the uptake of preventive asthma management actions such as the possession and use of a written asthma action plan.