Status:
COMPLETED
Remote Pulmonary Function Testing and Nurse Coaching in ALS
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
ALS Association
Conditions:
ALS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary function testing (rPFT) with or without the additional support of nurse coaching. This is a randomized con...
Detailed Description
This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory function can lead to timelier initiation of NIV and 2) whether structured nurse coaching leads to improved ...
Eligibility Criteria
Inclusion
- Patients:
- Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[Brooks2000\].
- Be 18 years of age or older.
- Have a caregiver available to participate in the study
- Symptom onset within the last three years.
- Have a computer and home internet service sufficient for engaging in telemedicine sessions.
- Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).
- Caregivers:
- Be 18 years of age or older, of either gender.
- Be able and willing to provide informed consent.
Exclusion
- Patients:
- Use of NIV or diaphragm pacer at time of obtaining informed consent.
- FVC ≤50% predicted or MIP \> -60 cm of water.
- ALS Functional Rating Scale (ALSFRS-R) \[Cedarbaum1999\] score on day of screening of ≥2 on items for speech, swallowing, and salivation. These items are indicators of bulbar dysfunction, which limits the reliability of PFT administration.
- Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
- Caregivers: None
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04490148
Start Date
July 1 2020
End Date
June 30 2024
Last Update
July 24 2024
Active Locations (1)
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1
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, United States, 17033