Clinical trial NCT02269618: Telehealth Program in Chronic Patients
Official title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Heart Failure
Keywords: Telehealth, Home-based, rehabilitation
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Our study want to investigate feasibility and efficacy of a multidisciplinary telehealth and tele-rehabilitation home based program in patients with COPD and CHF. This is an integrated, multidisciplinary nurse and therapist oriented program; these two figures have a central role during home based intervention and became an essential interface in the dialogue between patient and specialist. The nurse and therapist, each for their competence, collect information, carry out education and training, verify adherence to drug and physical therapy, verify the quality of caregiver assistance. When needed, they require intervention of specialist for consultation or second-opinion.

After drug therapy optimization and physical rehabilitation program definition, the patient will be allocated randomly into 2 groups: 1. Group A (usual care): the patients will be followed in the usual care manner by General Practitioner (GP) and routine specialist visits. 2. Group B (Home-based intervention): the patients will be monitored at home for 4 months by nurse and therapist and they will perform an individual rehabilitative program including at least 3 sessions/week of mini-ergometer and exercises and 2 sessions/week of walking with pedometer.

At baseline, after 4 months and further 2 months of follow-up all patients in both groups will undergo to follows clinical and physical evaluations:

1. ECG (T0; T4 if needed)
2. Echocardiogram (T0, T4 if needed
3. Spirometry (T0 or a spirometry available in the previous year)
4. Arterial blood gases (T0; T4)
5. Walking test (T0; T4; T6)
6. Metabolic Holter monitoring using the Body Monitoring Multi-Sensor Armband (BMSA) (SenseWear) worn at the triceps of the right arm for at least 72 h. (T0; T4; T6)

The questionnaires and scale :

1. Minnesota (T0;T4;T6)
2. COPD Assessment Test (CAT) (T0;T4;T6)
3. Barthel (T0;T4;T6)
4. Dyspnoea and muscle fatigue by Borg scale evaluation, referred by patient during his regular day (T0;T4;T6)
5. Medical Research Council (MRC) scale for dyspnoea during regular day (T0;T4;T6)
6. Physical activity scale for the elderly (PASE) (T0;T4;T6)
7. Customer satisfaction (T4, only group B)

Eligibility criteria: 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

Primary outcomes:
measure: Improvement tolerance capacity
timeFrame: 4 months and 6 months
Secondary outcomes:
measure: Reduction of hospitalisations for cardiovascular disease and /or respiratory disease
timeFrame: 4 months
measure: Reduction of hospitalisations for all-cases
timeFrame: 4 months
measure: energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity
timeFrame: 4 months and 6 months
measure: Improvement of quality of life
timeFrame: 4 months
measure: Reduction of clinical instabilities without hospital admission
timeFrame: 4 months
measure: Reduction of impairment/disability
timeFrame: 4 months
measure: Adherence to at least 70% proposal rehabilitative sessions
timeFrame: 4 months and 6 months
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: FSM Respiratory Unit
state: BS
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri, Cardiology Unit
state: BS
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri, Telemedicine Service
state: BS
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Michele Vitacca, MD
role: STUDY_CHAIR
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