Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
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|ClinicalTrials.gov Identifier: NCT00613899|
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Other: telesurveillance||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||October 2008|
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:
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).
Other Name: telemedicine
- To test a possible alternative of care for ALS patients (home vs hospital) [ Time Frame: 6-12 months ]
- To check patients and caregivers' acceptance [ Time Frame: 6-12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613899
|Lumezzane, BS, Italy, 25065|
|Study Chair:||michele vitacca, MD||FSM IRCCS Lumezzane|
|Principal Investigator:||michele vitacca, MD||FSM IRCCS LUmezzane (BS) ITALY|