Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      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:

        1. To test a possible alternative of care for ALS patients

        2. To check patients and caregivers' acceptance

        3. To measure time consuming for care team

        4. To quantify patient's comfort

        5. To test costs/effectiveness ratio.
    

Intervention name(s): telesurveillance
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): telemedicine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: home care; home rehabilitation; telemedicine; ALS