Pulmonary Disease, Chronic ObstructiveNCT02269618
Telehealth Program in Chronic Patients
A study testing Home-based telehealth program and Home-based rehabilitation in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by Fondazione Salvatore Maugeri at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Heart Failure
- What is being tested?
- Home-based telehealth program and Home-based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 3 sitesItaly
- Study dates
- Jun 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
FSM Respiratory Unit
Lumezzane, BS, 25066
Fondazione Salvatore Maugeri, Cardiology Unit
Lumezzane, BS
Fondazione Salvatore Maugeri, Telemedicine Service
Lumezzane, BS
About this study
Official title: 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
Read the 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:
- ECG (T0; T4 if needed)
- Echocardiogram (T0, T4 if needed
- Spirometry (T0 or a spirometry available in the previous year)
- Arterial blood gases (T0; T4)
- Walking test (T0; T4; T6)
- 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 :
- Minnesota (T0;T4;T6)
- COPD Assessment Test (CAT) (T0;T4;T6)
- Barthel (T0;T4;T6)
- Dyspnoea and muscle fatigue by Borg scale evaluation, referred by patient during his regular day (T0;T4;T6)
- Medical Research Council (MRC) scale for dyspnoea during regular day (T0;T4;T6)
- Physical activity scale for the elderly (PASE) (T0;T4;T6)
- Customer satisfaction (T4, only group B)
- Being tested
- Home-based telehealth program, Home-based rehabilitation, Usual care
- Keywords
- Telehealth, Home-based, rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based telehealth programOther
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.
Home-based rehabilitationOther
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.
Usual careOther
Usual care All patients will be followed also in usual care manner by their GPs.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group A) | Active comparator | The patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed Receives: Other: Usual care |
| Intervention group (Group B) | Other | 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 Receives: Other: Home-based telehealth program; Other: Home-based rehabilitation; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement tolerance capacity
The improvement in tolerance capacity will be measured by walking test performance (meters walked)
Measured: 4 months and 6 months
Secondary outcomes (7)
Reduction of hospitalisations for cardiovascular disease and /or respiratory disease
Measured: 4 months
Reduction of hospitalisations for all-cases
Measured: 4 months
energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity
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.
Measured: 4 months and 6 months
Improvement of quality of life
The improvement in quality of life, measured by Minnesota Questionnaire and CAT
Measured: 4 months
Reduction of clinical instabilities without hospital admission
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
Measured: 4 months
Reduction of impairment/disability
The reduction of impairment/disability will be measured with Barthel index
Measured: 4 months
Adherence to at least 70% proposal rehabilitative sessions
The adherence will be calculated only in the group B
Measured: 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Vitacca, Fondazione Salvatore Maugeri
- Investigators
- Michele Vitacca, MD, Study chair, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269618
- Sponsor's protocol ID
- N.160
- Status last verified
- Feb 2016
- First submitted
- 17 Oct 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.
PubMed 19168510Staszewsky L, Wong M, Masson S, Barlera S, Carretta E, Maggioni AP, Anand IS, Cohn JN, Tognoni G, Latini R; Valsartan Heart Failure Trial Investigators. Clinical, neurohormonal, and inflammatory markers and overall prognostic role of chronic obstructive pulmonary disease in patients with heart failure: data from the Val-HeFT heart failure trial. J Card Fail. 2007 Dec;13(10):797-804. doi: 10.1016/j.cardfail.2007.07.012.
PubMed 18068611Macchia A, Monte S, Romero M, D'Ettorre A, Tognoni G. The prognostic influence of chronic obstructive pulmonary disease in patients hospitalised for chronic heart failure. Eur J Heart Fail. 2007 Sep;9(9):942-8. doi: 10.1016/j.ejheart.2007.06.004. Epub 2007 Jul 12.
PubMed 17627878Almagro P, Castro A. Helping COPD patients change health behavior in order to improve their quality of life. Int J Chron Obstruct Pulmon Dis. 2013;8:335-45. doi: 10.2147/COPD.S34211. Epub 2013 Jul 24.
PubMed 23901267Walters JA, Cameron-Tucker H, Courtney-Pratt H, Nelson M, Robinson A, Scott J, Turner P, Walters EH, Wood-Baker R. Supporting health behaviour change in chronic obstructive pulmonary disease with telephone health-mentoring: insights from a qualitative study. BMC Fam Pract. 2012 Jun 13;13:55. doi: 10.1186/1471-2296-13-55.
PubMed 22694996Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.
PubMed 18799512Giordano A, Scalvini S, Zanelli E, Corra U, Longobardi GL, Ricci VA, Baiardi P, Glisenti F. Multicenter randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Int J Cardiol. 2009 Jan 9;131(2):192-9. doi: 10.1016/j.ijcard.2007.10.027. Epub 2008 Jan 28.
PubMed 18222552Paneroni M, Colombo F, Papalia A, Colitta A, Borghi G, Saleri M, Cabiaglia A, Azzalini E, Vitacca M. Is Telerehabilitation a Safe and Viable Option for Patients with COPD? A Feasibility Study. COPD. 2015 Apr;12(2):217-25. doi: 10.3109/15412555.2014.933794. Epub 2014 Aug 5.
PubMed 25093419McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD007718. doi: 10.1002/14651858.CD007718.pub2.
PubMed 21735417Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Williams JW Jr. Effects of Nurse-Managed Protocols in the Outpatient Management of Adults with Chronic Conditions [Internet]. Washington (DC): Department of Veterans Affairs (US); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK241377/
PubMed 25210722Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633Bernocchi P, Scalvini S, Galli T, Paneroni M, Baratti D, Turla O, La Rovere MT, Volterrani M, Vitacca M. A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial. Trials. 2016 Sep 22;17(1):462. doi: 10.1186/s13063-016-1584-x.
PubMed 27659741
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02269618
- Acronym / sponsor ID
- N.160
- Keywords
- Telehealth, Home-based, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- ECG (T0; T4 if needed)
- Echocardiogram (T0, T4 if needed
- Spirometry (T0 or a spirometry available in the previous year)
- Arterial blood gases (T0; T4)
- Walking test (T0; T4; T6)
- 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 :
- Minnesota (T0;T4;T6)
- COPD Assessment Test (CAT) (T0;T4;T6)
- Barthel (T0;T4;T6)
- Dyspnoea and muscle fatigue by Borg scale evaluation, referred by patient during his regular day (T0;T4;T6)
- Medical Research Council (MRC) scale for dyspnoea during regular day (T0;T4;T6)
- Physical activity scale for the elderly (PASE) (T0;T4;T6)
- Customer satisfaction (T4, only group B)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Group A) | Active comparator | Other: Usual careThe patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed |
| Intervention group (Group B) | Other | Other: Home-based telehealth program, Other: Home-based rehabilitation, Other: Usual careGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based telehealth programHome-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 | Intervention group (Group B) |
| Home-based rehabilitationHome-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 | Intervention group (Group B) |
| Usual careUsual care All patients will be followed also in usual care manner by their GPs. | Other | Control group (Group A), Intervention group (Group B) |
Primary outcome
Improvement tolerance capacity
Time frame: 4 months and 6 months
The improvement in tolerance capacity will be measured by walking test performance (meters walked)
7 secondary outcomes
Reduction of hospitalisations for cardiovascular disease and /or respiratory disease
Time frame: 4 months
Reduction of hospitalisations for all-cases
Time frame: 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
Improvement of quality of life
Time frame: 4 months
Reduction of clinical instabilities without hospital admission
Time frame: 4 months
Reduction of impairment/disability
Time frame: 4 months
Adherence to at least 70% proposal rehabilitative sessions
Time frame: 4 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Background: PubMed 19168510Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.
- Background: PubMed 18068611Staszewsky L, Wong M, Masson S, Barlera S, Carretta E, Maggioni AP, Anand IS, Cohn JN, Tognoni G, Latini R; Valsartan Heart Failure Trial Investigators. Clinical, neurohormonal, and inflammatory markers and overall prognostic role of chronic obstructive pulmonary disease in patients with heart failure: data from the Val-HeFT heart failure trial. J Card Fail. 2007 Dec;13(10):797-804. doi: 10.1016/j.cardfail.2007.07.012.
- Background: PubMed 17627878Macchia A, Monte S, Romero M, D'Ettorre A, Tognoni G. The prognostic influence of chronic obstructive pulmonary disease in patients hospitalised for chronic heart failure. Eur J Heart Fail. 2007 Sep;9(9):942-8. doi: 10.1016/j.ejheart.2007.06.004. Epub 2007 Jul 12.
- Background: PubMed 23901267Almagro P, Castro A. Helping COPD patients change health behavior in order to improve their quality of life. Int J Chron Obstruct Pulmon Dis. 2013;8:335-45. doi: 10.2147/COPD.S34211. Epub 2013 Jul 24.
- Background: PubMed 22694996Walters JA, Cameron-Tucker H, Courtney-Pratt H, Nelson M, Robinson A, Scott J, Turner P, Walters EH, Wood-Baker R. Supporting health behaviour change in chronic obstructive pulmonary disease with telephone health-mentoring: insights from a qualitative study. BMC Fam Pract. 2012 Jun 13;13:55. doi: 10.1186/1471-2296-13-55.
- Background: PubMed 18799512Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.
- Background: PubMed 18222552Giordano A, Scalvini S, Zanelli E, Corra U, Longobardi GL, Ricci VA, Baiardi P, Glisenti F. Multicenter randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Int J Cardiol. 2009 Jan 9;131(2):192-9. doi: 10.1016/j.ijcard.2007.10.027. Epub 2008 Jan 28.
- Background: PubMed 25093419Paneroni M, Colombo F, Papalia A, Colitta A, Borghi G, Saleri M, Cabiaglia A, Azzalini E, Vitacca M. Is Telerehabilitation a Safe and Viable Option for Patients with COPD? A Feasibility Study. COPD. 2015 Apr;12(2):217-25. doi: 10.3109/15412555.2014.933794. Epub 2014 Aug 5.
- Background: PubMed 21735417McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD007718. doi: 10.1002/14651858.CD007718.pub2.
- Background: PubMed 25210722Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Williams JW Jr. Effects of Nurse-Managed Protocols in the Outpatient Management of Adults with Chronic Conditions [Internet]. Washington (DC): Department of Veterans Affairs (US); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK241377/
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Derived from this study: PubMed 27659741Bernocchi P, Scalvini S, Galli T, Paneroni M, Baratti D, Turla O, La Rovere MT, Volterrani M, Vitacca M. A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial. Trials. 2016 Sep 22;17(1):462. doi: 10.1186/s13063-016-1584-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Vitacca, MD study chair
Fondazione Salvatore Maugeri
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based telehealth program and Home-based rehabilitation in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by Fondazione Salvatore Maugeri at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement tolerance capacity (time frame: 4 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269618, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.