Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fondazione Salvatore Maugeri
- Enrollment
- 113
- Locations
- 3
- Primary Endpoint
- Improvement tolerance capacity
Study Overview
Brief Summary
The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity
Detailed Description
COPD and CHF frequently coexist, causing a significant worsening in the quality of life of the patients and increasing morbidity and mortality. The prevalence of COPD in the CHF patients ranges from 20% to 32% of cases, and CHF is prevalent in more than 20% of patients with COPD.
COPD and CHF patients are complicated and frail with a high risk of re-hospitalizations; for this reason an individualized and multidisciplinary program need to be implemented in these patients. The chronic disease trend is fluctuating, burdened by many exacerbations through a vicious circle with dyspnoea, decreased activity, new exacerbations, depression and social isolation, leading to death.
The weight of evidence from a meta-analysis of randomized trials indicates that a multidisciplinary disease-management approach has the best outcomes in terms of prolonged survival and reduced hospital-readmission rates. Home-based management might, arguably, be the preferred approach after hospitalization of chronic diseases patients.
Home-base management might provide an opportunity to prevent clinical deterioration and hospitalizations by a comprehensive, long-term intervention with regular reinforcement of patient adherence, knowledge, and skills. A personalized hospital-discharge programme seems to be the best approach to plan the follow-up care of patients with chronic diseases.
These programmes, particularly important in the care of patients with multiple comorbidities, should include a routine self-management support, consisting in education to recognize symptoms early, to manage medical devices, to identify barriers to adherence to therapy such as adverse effects of drugs, and to check that the intensity of physical therapy is appropriate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •COPD new GOLD classification (B, C and D class) and a spirometry in the previous year and
- •Systolic and/or diastolic CHF defined at least by an echocardiogram performed in clinical stability; II, III and IV New York Heart Association class and optimized drug therapy.
- •Informed consent signed
Exclusion Criteria
- •Physical activity limitations caused by non-cardiac and/or pulmonary problems
- •Obstructive Cardiomyopathies and/or myocarditis
- •Non cardiac and/or pulmonary pathologies that would cause the death of the patient during the study
- •Poor adherence and compliance of the patient
Arms & Interventions
Control group (Group A)
The patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed
Intervention: Usual care (Other)
Intervention group (Group B)
Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:
- Home-based telehealth program
- Home-based rehabilitation
Intervention: Home-based telehealth program (Other)
Intervention group (Group B)
Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:
- Home-based telehealth program
- Home-based rehabilitation
Intervention: Home-based rehabilitation (Other)
Intervention group (Group B)
Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:
- Home-based telehealth program
- Home-based rehabilitation
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Improvement tolerance capacity
Time Frame: 4 months and 6 months
The improvement in tolerance capacity will be measured by walking test performance (meters walked)
Secondary Outcomes
- Reduction of hospitalisations for cardiovascular disease and /or respiratory disease(4 months)
- Reduction of hospitalisations for all-cases(4 months)
- Improvement of quality of life(4 months)
- energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity(4 months and 6 months)
- Reduction of impairment/disability(4 months)
- Reduction of clinical instabilities without hospital admission(4 months)
- Adherence to at least 70% proposal rehabilitative sessions(4 months and 6 months)
Investigators
Michele Vitacca
Responsible of Respiratory Unit
Fondazione Salvatore Maugeri