Telehealth Program in Chronic Patients

Heart Failure Clinical Trial

Official title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.

Status Completed

Clinical Trial 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

Clinical Trial 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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease
• Heart Failure
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT02269618
• Study type: Interventional
• Source: Fondazione Salvatore Maugeri
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: March 2015