Telehealth Program in Chronic Patients

February 5, 2016 updated by: Michele Vitacca, Fondazione Salvatore Maugeri

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BS
      • Lumezzane, BS, Italy, 25066
        • FSM Respiratory Unit
      • Lumezzane, BS, Italy
        • Fondazione Salvatore Maugeri, Cardiology Unit
      • Lumezzane, BS, Italy
        • Fondazione Salvatore Maugeri, Telemedicine Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (Group A)
The patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed
Other: Usual care
Usual care All patients will be followed also in usual care manner by their GPs.
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:

  1. Home-based telehealth program
  2. Home-based rehabilitation
Other: Usual care
Usual care All patients will be followed also in usual care manner by their GPs.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement tolerance capacity
Time Frame: 4 months and 6 months
The improvement in tolerance capacity will be measured by walking test performance (meters walked)
4 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of hospitalisations for cardiovascular disease and /or respiratory disease
Time Frame: 4 months
4 months
Reduction of hospitalisations for all-cases
Time Frame: 4 months
4 months
energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity
Time Frame: 4 months and 6 months
The outcome will be measured in a subgroup of patients using 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.
4 months and 6 months
Improvement of quality of life
Time Frame: 4 months
The improvement in quality of life, measured by Minnesota Questionnaire and CAT
4 months
Reduction of clinical instabilities without hospital admission
Time Frame: 4 months
The reduction of clinical instabilities will be measured by number of times that patients need to use antibiotics and/or corticosteroids and/or number of times that patients need to increase dosage of diuretic
4 months
Reduction of impairment/disability
Time Frame: 4 months
The reduction of impairment/disability will be measured with Barthel index
4 months
Adherence to at least 70% proposal rehabilitative sessions
Time Frame: 4 months and 6 months
The adherence will be calculated only in the group B
4 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Investigators

  • Study Chair: Michele Vitacca, MD, Fondazione Salvatore Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N.160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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