Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing patients' quality of life and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions. However, no data exist in patients with combined COPD/CHF. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated, home-based, medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD/CHF. The purpose of the paper is to describe the rationale and design of the trial.
Methods/designs: Patients, after inpatient rehabilitation, were randomly assigned to the intervention or control group, followed for 4 months at home, then assessed at 4 and 6 months. The intervention group followed a telesurveillance (telephone contacts by nurse and remote monitoring of cardiorespiratory parameters) and home-based rehabilitation program (at least three sessions/week of mini-ergometer exercises, callisthenic exercises and twice weekly pedometer-driven walking, plus telephone contacts by a physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6 months, the 6-min Walk Test, dyspnea and fatigue at rest, oxygenation (PaO2/FiO2), physical activity profile (PASE questionnaire), and QoL (Minnesota and CAT questionnaires) were assessed. During the study, serious clinical events (hospitalizations or deaths) were recorded.
Discussion: Currently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients who are at very high risk of exacerbations.
Trial registration: Network per la prevenzione e la sanità pubblica, CCM, Ministero della Salute "Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso: studio di implementazione, validazione e impatto," registered on 14 January 2014. ClinicalTrials.gov Identifier: NCT02269618 , registered on 17 October 2014.
Keywords: Chronic heart failure; Chronic obstructive pulmonary disease; Telehealth; Telemedicine technology.