Optimizing NIPPV Use for Patients With ALS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ALS Association
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01035476
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 16, 2009
December 16, 2009
December 2009
December 2010   (final data collection date for primary outcome measure)
Length of time on NIPPV [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Patient sleep quality, mood, fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Optimizing NIPPV Use for Patients With ALS
Effectiveness Trial of Detailed NIPPV Feedback to Patients

This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.

The data card records critical features of NIPPV acceptance (hours and timing of use) and adherence (apnea/hypopnea index, mask leak, minute ventilation); but to date data card monitoring has not yet been incorporated fully into ALS clinic practice. We will limit our focus to patients who meet Medicare-reimbursement criteria or AAN-recommended practice parameters for initiating NIPPV. The larger question guiding this research is whether data card monitoring and communication of these results to clinicians and patient families promotes "optimal use" of NIPPV. We define optimal use as (i) high acceptance, as indicated by daily night time use greater than 4 hours, and (ii) high adherence, as indicated by apnea/hypopnea index, mask leak, and minute ventilation. We will test whether timely reporting of acceptance and adherence values to patients and clinicians increases the likelihood of (i) changes in orofacial masks and settings on devices and continued use of devices, and (ii) positive patient mood and sleep quality and lower caregiver burden over follow-up.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
ALS
Behavioral: Data Card Report
Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
  • Experimental: Data Card Report
    Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.
    Intervention: Behavioral: Data Card Report
  • No Intervention: Stabrad NIPPV Care
    Patients receive routine monitoring and care related to NIPPV.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Definite or probable ALS
  • Medicare or AAN criteria for initiating NIPPV
  • Community resident
  • English speaker

Exclusion Criteria:

  • Unable to give informed consent
  • Other pulmonary or cardiac conditions that complicate use of NIPPV
  • Report from physician that participation would be harmful
Both
18 Years to 90 Years
No
Contact: Danielle Rowlands 412-647-1706 doerdx@upmc.edu
United States
 
NCT01035476
ALSA-P-2008-09
Yes
Steven M. Albert, PhD, University of Pittsburgh
University of Pittsburgh
ALS Association
Principal Investigator: Steven Albert, PhD University of Pittsburgh
Study Director: David Lacomis, MD University of Pittsburgh
University of Pittsburgh
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP