Study Purpose: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 controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.
Type of Intervention:
remote pulmonary function testing, standard pulmonary function testing, Nurse Respiratory Health Coaching (NRHC)
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, 17033 United States
Full Study Summary:
Milton S. Hershey Medical Center
Estimated Study Start Date:
07 / 01 / 2020
Estimated Study Completion Date:
06 / 30 / 2023
Posting Last Modified Date:
07 / 14 / 2022
Date Study Added to neals.org:
07 / 28 / 2020
Can participants use Riluzole?
1. Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000].
2. Be 18 years of age or older.
3. Have a caregiver available to participate in the study
4. Symptom onset within the last three years.
5. Have a computer and home internet service sufficient for engaging in telemedicine sessions.
6. Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).
1. Be 18 years of age or older, of either gender.
2. Be able and willing to provide informed consent.
1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
2. FVC ≤50% predicted or MIP > -60 cm of water.
3. 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.
4. Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
Hershey Medical Center ALS Clinic | Recruiting