An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial

Chronic heart failure (CHF) is a prevalent and debilitating condition and is most common in the elderly population. Apart from the symptoms that individuals suffer and the burden on their families, this condition poses a substantial economic burden for the wider society[1, 2]. It is estimated that CHF costs Australia AUD$1 billion annually, with the bulk of these costs related to hospitalization[3]. Studies have shown that at least 40% of readmissions to hospital for CHF are due to non-compliance with treatment recommendations and inadequate patient information[4]. Although physical activity is important and beneficial in the management of CHF, many individuals consider that adhering to physical activity recommendations is harder compared to implementing strategies related to medications, dietary modifications or fluid restriction[5].

The theoretical concept underpinning adherence to physical activity is self-efficacy, which is the central concept of self-management[6]. Individuals' exercise self-efficacy determines, in part, an individual's ability to initiate and sustain an exercise program[6]. Because the benefits of physical activity are often not immediately felt, this can be a barrier to sustainable behavior change. Without prompted monitoring of progress, the importance and usefulness of physical activity is likely to be overlooked. In addition, while many people with CHF are managing in the community, monitoring of physical functional capacity is most often undertaken in a clinical environment where it requires well-trained staff and equipment. Hospitalisation for CHF can occur when individuals fail to recognise the signs and symptoms of deteriorating physical function. Without adequate knowledge and support, signs and symptoms such as shortness of breath, weight gain or increasing fatigue can be disregarded[7]. Self-monitoring is one important but often under-utilised self-management behaviors[8, 9].

With the aim of assisting individuals and clinicians to monitor and promote physical activity, we developed the Home-Heart-Walk (HHW). The HHW has been developed based on the principle of self-efficacy and the mechanistic elements of the 6MWT[10]. The HHW is a self-administered, modified 6MWT. We chose to base the HHW protocol on the 6MWT over other exercise tests because of its simple, safe and inexpensive characteristics and the ability to consider data sharing in the future. The HHW program is a structured, self-monitoring exercise program, which incorporates regular HHW and telephone follow-up. After developing the HHW prototype, we have assessed the correlation of the HHW distance and the 6MWT distance in a group of 13 healthy adult (age 23 to 59) and the reliability and feasibility in a group of 29 cardiac rehabilitation participants[11]. The correlation between the two tests distances was r = 0.81[11]. The intra-class correlation coefficient of the test distance over a 7 day period was 0.98 and the inter-rater correlation was almost perfect (r = 0.99)[12]. Given the impact that regular monitoring of the HHW could have on the management of CHF, a randomized controlled trial to assess the ability of the HHW to promote self-management and exercise self-efficacy was devised.

The HHW study is a multicentre, non-blinded, parallel arm, randomized controlled trial. For each individual, the study will last for 6 months, and recruitment to the whole study is expected to be completed within twelve months.

Demographic information, clinical status, functional and general health status as well as their self-management capacity as shown in Table 2 will be collected for participants in both the intervention and control group. A brief physical examination is carried out on all participants to collect the following data: height; weight; waist circumference; hip circumference; heart rate; blood pressure; pulse oximetry; and a cardio-respiratory examination.

Individuals who participate in the study undergo a baseline physical assessment, a standard 6MWT, and receive an information session from a cardiac nurse on HF self-management. They are also provided with National Heart Foundation Consumer Resource Guide[22]. A summary of study schemata is presented as Figure 2.

This HHW study is a novel approach to self-management in CHF. Low adherence to health recommendations suggest the need to explore ways of better promoting adherence to clinical advice and develop innovative interventions for monitoring and managing people with CHF in community settings. If evaluated as being successful, the HHW protocol can be readily incorporated into the community based management of CHF. In particular it has the potential to reach the subgroup of CHF population who have limited physical functional capacity and are not appropriate for higher intensity physical activity. At the same time, this self-monitoring intervention if shown to be beneficial would also assist in managing people living in areas where clinical based, supervised programs are not easily accessible.

The use of self-reported instruments could be a potential limitation of this study, because the risk of over reporting or under reporting from the participants and is likely to be evenly distributed between the randomized groups. However, this is inevitable with any kind of study using self-reporting instruments. The study instruments and scoring will be discussed when reporting study findings. Enrolment of the 166 participants will continue through 2010. After recruitment of the 166 participants, the baseline characteristics of the participants will be analysed. Outcome assessment is projected to be completed by mid 2011.