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

This study has been completed.
Sponsor:
Information provided by:
Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00613899
First received: January 17, 2008
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Device: Nonin 9500 oxymeter
Device: In-Exoflator device (Emerson)
Device: telesurveillance
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • To test a possible alternative of care for ALS patients (home vs hospital) [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To check patients and caregivers' acceptance [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telesurveillance
40 ALS patients will submitted to a telesurveillance program (TP)after 2 hours educational hospital sections (air stacking with Ambu balloon, manual manoeuvres and In-Exoflator indications and use)
Device: Nonin 9500 oxymeter
Nonin 9500 oxymeter Minneapolis Plymouth USA
Other Name: saturimetric device for SpO2 named "Nonin 9500"
Device: In-Exoflator device (Emerson)
In-exoflator machine to facilitate expectoration and cough assistance
Other Name: cough assistance control
Device: telesurveillance
use of telesurveillance and In-exoflator device for cough assistance
Other Name: telemedicine

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613899

Locations
Italy
Michele Vitacca
Lumezzane, BS, Italy, 25066
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Study Chair: michele vitacca, MD FSM IRCCS Lumezzane
Principal Investigator: michele vitacca, MD FSM IRCCS LUmezzane (BS) ITALY
  More Information

Additional Information:
Publications:
Responsible Party: AISLA (italian association amyothrophic lateral sclerosis), AISLA
ClinicalTrials.gov Identifier: NCT00613899     History of Changes
Other Study ID Numbers: N°83researchbookFSM2006
Study First Received: January 17, 2008
Last Updated: July 6, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
home care
home rehabilitation
telemedicine
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014