Clinical trial NCT00613899: Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
Official title: Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Amyotrophic Lateral Sclerosis
Keywords: home care
home rehabilitation
telemedicine
ALS
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To test a possible alternative of care for ALS patients (home vs hospital)
timeFrame: 6-12 months
Secondary outcomes:
measure: To check patients and caregivers' acceptance
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Michele Vitacca
state: BS
Study officials:
affiliation: FSM IRCCS Lumezzane
name: michele vitacca, MD
role: STUDY_CHAIR
affiliation: FSM IRCCS LUmezzane (BS) ITALY
name: michele vitacca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vitacca 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.
citation: Paneroni 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.