Amyotrophic Lateral SclerosisPhase 4NCT00613899
Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
A Phase 4 study testing telesurveillance in people with Amyotrophic Lateral Sclerosis, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
The investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- telesurveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Oct 2008
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 ALS patients (VC < 80% with or without tracheostomy)will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.
Read the detailed description
Background: Amyotrophic Lateral Sclerosis (ALS) patients present reduction in the inspiratory and expiratory muscle strength, frequent secretions increase, insufficient expectoration ability with inevitable risk of acute respiratory failure (ARF) and necessity of hospitalizations. Recently, new mechanical tools (In-Exoflator EmersonR) are available in our hospital to help patients to expectorate during ARF. It is well noted these patients are particularly reluctant to be hospitalized to avoid further worsening in their quality of life.
Aim: the investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.
Methods: A telesurveillance program (TP), a pulsed saturimetric device, 2 hours educational hospital sections (air stacking with Ambu balloon, manual manoeuvres and In-Exoflator indications and use) will be offered to all ALS consecutive patients.
In details the TP is structured as follows: 1) Domiciliary Telesurveillance by only one 24-h Service Centre (SC) for enrolled pts with ALS in hospital discharge phase, 2) Patients - taken care of five days/week by a nurse-tutor (NT) and respiratory therapist (RT) according to a predefined appointments, 3) for 24-hr. duration (in case of symptoms) patients can call SC and talk to pneumologists that can intervene whenever needed for diagnostic-therapeutic adjustments. 4) In case of need the patient can contact the neurologist or psychologist; 5) The RT in accordance with pneumologist can decide for a domiciliary visit to patient.
Home RT accesses and In-Exoflator activation will be prescribed when patients will present worsening of three points in pSaTO2, 30% in peak cough expiratory flow (PCEF), lack of cough ability with increase in secretions and or suctions necessity (in tracheotomy patients) and clinical symptoms (dyspnoea, fever, headache, somnolence).
Number of In-Ex and air stacking activations, ARF episodes, hospital accesses, antibiotic therapy, customer satisfaction, PCF/PEF, MIC-VC, respiratory function (MIP, MEP, FEV1, FVC, FEV1/FVC, ABG), dyspnoea (Borg scale), general disability (Hoevelaken scale and ALS Functional Rating Scale) and survival will be collected.
Expected results: 30 ALS patients (VC < 80% and 40% with tracheotomy) will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation. This study will allow:
- To test a possible alternative of care for ALS patients
- To check patients and caregivers' acceptance
- To measure time consuming for care team
- To quantify patient's comfort
- To test costs/effectiveness ratio.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- telesurveillance
- Keywords
- home care, home rehabilitation, telemedicine, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telesurveillanceOther
Also called telemedicine
A telesurveillance program for cough assistance will be approched by the use of an in-exoflator device. Measurement of oxygen saturation (SpO2) will be performed by a Nonin 9500 oxymeter (Minneapolis Plymouth USA).
| Study group | Role | What they receive |
|---|---|---|
| Telesurveillance | Other | At time of discharge from hospital, 40 ALS patients willbe enrolled in a telesurveillance program (TP) for the management of cought at home.
Two hours of an in-hospital educational training will be provided to patients and caregivers on the use of:
1. air stacking with Ambu balloon
2. manual manoeuvres and
3. in-Exoflator device indications and use Receives: Other: telesurveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test a possible alternative of care for ALS patients (home vs hospital)
Measured: 6-12 months
Secondary outcomes (1)
To check patients and caregivers' acceptance
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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, FSM IRCCS Lumezzanemichele vitacca, MD, Principal investigator, FSM IRCCS LUmezzane (BS) ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613899
- Sponsor's protocol ID
- N°83_researchbookFSM2006
- Status last verified
- Jul 2011
- First submitted
- 17 Jan 2008
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sancho J, Servera E, Diaz J, Marin J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. doi: 10.1378/chest.125.4.1400.
PubMed 15078752Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gile S, Winck JC, Goncalves MR. At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis. Am J Phys Med Rehabil. 2010 May;89(5):401-6. doi: 10.1097/PHM.0b013e3181d89760.
PubMed 20407305Paneroni M, Trainini D, Winck JC, Vitacca M. Pilot study for home monitoring of cough capacity in amyotrophic lateral sclerosis: A case series. Rev Port Pneumol. 2014 Jul-Aug;20(4):181-7. doi: 10.1016/j.rppneu.2013.11.003. Epub 2014 Feb 1.
PubMed 24491372
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
- ClinicalTrials.gov ID
- NCT00613899
- Acronym / sponsor ID
- N°83_researchbookFSM2006
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- home care, home rehabilitation, telemedicine, ALS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Feb 2008 (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 investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.
Detailed description
Background: Amyotrophic Lateral Sclerosis (ALS) patients present reduction in the inspiratory and expiratory muscle strength, frequent secretions increase, insufficient expectoration ability with inevitable risk of acute respiratory failure (ARF) and necessity of hospitalizations. Recently, new mechanical tools (In-Exoflator EmersonR) are available in our hospital to help patients to expectorate during ARF. It is well noted these patients are particularly reluctant to be hospitalized to avoid further worsening in their quality of life.
Aim: the investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.
Methods: A telesurveillance program (TP), a pulsed saturimetric device, 2 hours educational hospital sections (air stacking with Ambu balloon, manual manoeuvres and In-Exoflator indications and use) will be offered to all ALS consecutive patients.
In details the TP is structured as follows: 1) Domiciliary Telesurveillance by only one 24-h Service Centre (SC) for enrolled pts with ALS in hospital discharge phase, 2) Patients - taken care of five days/week by a nurse-tutor (NT) and respiratory therapist (RT) according to a predefined appointments, 3) for 24-hr. duration (in case of symptoms) patients can call SC and talk to pneumologists that can intervene whenever needed for diagnostic-therapeutic adjustments. 4) In case of need the patient can contact the neurologist or psychologist; 5) The RT in accordance with pneumologist can decide for a domiciliary visit to patient.
Home RT accesses and In-Exoflator activation will be prescribed when patients will present worsening of three points in pSaTO2, 30% in peak cough expiratory flow (PCEF), lack of cough ability with increase in secretions and or suctions necessity (in tracheotomy patients) and clinical symptoms (dyspnoea, fever, headache, somnolence).
Number of In-Ex and air stacking activations, ARF episodes, hospital accesses, antibiotic therapy, customer satisfaction, PCF/PEF, MIC-VC, respiratory function (MIP, MEP, FEV1, FVC, FEV1/FVC, ABG), dyspnoea (Borg scale), general disability (Hoevelaken scale and ALS Functional Rating Scale) and survival will be collected.
Expected results: 30 ALS patients (VC < 80% and 40% with tracheotomy) will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation. This study will allow:
- To test a possible alternative of care for ALS patients
- To check patients and caregivers' acceptance
- To measure time consuming for care team
- To quantify patient's comfort
- To test costs/effectiveness ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telesurveillance | Other | Other: telesurveillanceAt time of discharge from hospital, 40 ALS patients willbe enrolled in a telesurveillance program (TP) for the management of cought at home. Two hours of an in-hospital educational training will be provided to patients and caregivers on the use of: 1. air stacking with Ambu balloon 2. manual manoeuvres and 3. in-Exoflator device indications and use |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 ALS patients (VC < 80% with or without tracheostomy)will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| telesurveillanceAlso: telemedicineA telesurveillance program for cough assistance will be approched by the use of an in-exoflator device. Measurement of oxygen saturation (SpO2) will be performed by a Nonin 9500 oxymeter (Minneapolis Plymouth USA). | Other | Telesurveillance |
Primary outcome
To test a possible alternative of care for ALS patients (home vs hospital)
Time frame: 6-12 months
1 secondary outcome
To check patients and caregivers' acceptance
Time frame: 6-12 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 4 Feb 2016.
- Background: PubMed 15078752Sancho J, Servera E, Diaz J, Marin J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. doi: 10.1378/chest.125.4.1400.
- Results publication: PubMed 20407305Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gile S, Winck JC, Goncalves MR. At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis. Am J Phys Med Rehabil. 2010 May;89(5):401-6. doi: 10.1097/PHM.0b013e3181d89760.
- Derived from this study: PubMed 24491372Paneroni M, Trainini D, Winck JC, Vitacca M. Pilot study for home monitoring of cough capacity in amyotrophic lateral sclerosis: A case series. Rev Port Pneumol. 2014 Jul-Aug;20(4):181-7. doi: 10.1016/j.rppneu.2013.11.003. Epub 2014 Feb 1.
- association of amyotrophic lateral sclerosis patientsLink provided by the sponsor.
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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
FSM IRCCS Lumezzane
michele vitacca, MD principal investigator
FSM IRCCS LUmezzane (BS) ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telesurveillance in people with Amyotrophic Lateral Sclerosis, run by Fondazione Salvatore Maugeri at 1 site 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 1 inclusion and 1 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 4 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 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To test a possible alternative of care for ALS patients (home vs hospital) (time frame: 6-12 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 NCT00613899, which also lists 3 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 4 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.