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

NCT00613899 | Completed Phase 4

• 1 other identifier: N°83_researchbookFSM2006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

home care; home rehabilitation; telemedicine; ALS

Outcome Measures

Primary Outcomes (1)

• To test a possible alternative of care for ALS patients (home vs hospital)

  6-12 months

Secondary Outcomes (1)

• To check patients and caregivers' acceptance

  6-12 months

Study Arms (1)

Telesurveillance

OTHER

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

Other: telesurveillance

Interventions

telesurveillance OTHER

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).

Also known as: telemedicine

Telesurveillance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Michele Vitacca

Lumezzane, BS, 25065, Italy

Location

Related Publications (3)

• 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.

  PMID: 15078752 BACKGROUND

• 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.

  PMID: 20407305 RESULT

• 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.

  PMID: 24491372 DERIVED

Related Links

• association of amyotrophic lateral sclerosis patients

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• michele vitacca, MD

  FSM IRCCS Lumezzane

  STUDY CHAIR

• michele vitacca, MD

  FSM IRCCS LUmezzane (BS) ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: February 13, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 4, 2016

Record last verified: 2011-07

Locations

IT (1)