Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

Fondazione Salvatore Maugeri

Status and phase: Completed; Phase 4

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: telesurveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT00613899

N°83_researchbookFSM2006

Details and patient eligibility

About

The investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40 ALS patients (VC < 80% with or without tracheostomy)will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Telesurveillance

Other group

Description:

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

Treatment:

Other: telesurveillance