Optimizing NIPPV Use for Patients With ALS
Recruitment status was Recruiting
This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.
|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|
- Length of time on NIPPV [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient sleep quality, mood, fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035476
|Contact: Danielle Rowlandsfirstname.lastname@example.org|
|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|
|Principal Investigator:||Steven Albert, PhD||University of Pittsburgh|
|Study Director:||David Lacomis, MD||University of Pittsburgh|