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
  Purpose

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


Condition Intervention Phase
ALS
Behavioral: Data Card Report
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness Trial of Detailed NIPPV Feedback to Patients

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Length of time on NIPPV [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient sleep quality, mood, fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Data Card Report
Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.
Behavioral: Data Card Report
Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
No Intervention: Stabrad NIPPV Care
Patients receive routine monitoring and care related to NIPPV.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01035476

Contacts
Contact: Danielle Rowlands 412-647-1706 doerdx@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Danielle Rowlands    412-647-1706      
Sub-Investigator: Patrick Strollo, MD         
Sub-Investigator: David Kristo, MD         
Sponsors and Collaborators
University of Pittsburgh
ALS Association
Investigators
Principal Investigator: Steven Albert, PhD University of Pittsburgh
Study Director: David Lacomis, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Steven M. Albert, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01035476     History of Changes
Other Study ID Numbers: ALSA-P-2008-09
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ALS
nasal ventilation
data card recording

ClinicalTrials.gov processed this record on July 31, 2014