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Telehealth Program in Chronic Patients

NCT02269618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2016-02-08

No results posted yet for this study

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

Conditions

Interventions

OTHER

Home-based telehealth program

Home-based telehealth program * Scheduled calls initiated by nurse performed weekly; the nurse carried out a standardized interview on general clinical condition of the patients. * Unscheduled calls initiated by patients or caregivers through the service centre(24h/24h) to report any clinical problems. in case of signs or symptoms * Telemonitoring: during calls, patients can transmit via landline or mobile phone the recordings from the 1-lead ECG to a service centre, and talk to the nurse or doctor * Home visit performed by therapist seven days after hospital discharge by setting the daily physical activity and other home visits in case of need * Scheduled calls initiated by therapist performed weekly aimed at increasing workload and evaluating the proper execution of exercises.

OTHER

Home-based rehabilitation

Home-based rehabilitation Individual rehabilitative program including at least 3 sessions/week of mini-ergometer and exercises and 2 sessions/week of walking with pedometer * Mini-ergometer: The personalized protocol will be structured at the beginning on the basis of data obtained from the assessment of the baseline exercise test, trying to get a training activity to the maximum value of around a Borg dyspnoea and motor equal to 6 (according to the protocol of Maltais) * Walking: The patient will be encouraged to walk every day. Will be given a pedometer and will be asked to try to increase the amount of steps up to the maximal for the patient.

OTHER

Usual care

Usual care All patients will be followed also in usual care manner by their GPs.

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    lead OTHER

Principal Investigators

  • Michele Vitacca, MD · Fondazione Salvatore Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269618 on ClinicalTrials.gov