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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

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

Hui Y Du, Phillip J Newton, Robert Zecchin, Robert Denniss, Yenna Salamonson, Bronwyn Everett, David C Currow, Peter S Macdonald, Patricia M Davidson
Trials 2011, 12: 63
21366927

BACKGROUND: Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF.

METHODS/DESIGN: A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain).All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction); medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale of the Medical Outcome Study Short Form -36. Secondary outcomes include physical functional capacity measured by the standard six minute walk test, self-management capacity, health related quality of life measured by Medical Outcome Study Short Form -36 and Minnesota Living With Heart Failure Questionnaire, self-efficacy and self-care behaviour.

DISCUSSION: A self-monitoring intervention that can improve individual's exercise self-efficacy, self-management capacity could have potential significance in improving the management of people with chronic heart failure in community settings.

TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry 12609000437268.

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