N/A
Completed N=29
Remote Pulmonary Function Testing and Nurse Coaching in ALS
ALS
Source: ClinicalTrials.gov NCT04490148 ↗
Enrolled (actual)
29
Serious AEs
24.1%
Results posted
Jun 2024
Primary outcomePrimary: Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring — 176 days after enrollment
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 controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring |
176 | — |
| PRIMARY Date of Identification of NIV Need From Standard PFT Monitoring |
259 | — |
| PRIMARY Self-efficacy for Managing Medications and Treatments |
-.238; .474 | — |
| PRIMARY Self-efficacy for Managing Social Interactions |
-.041; -.181 | — |
| PRIMARY Self-efficacy for Managing Symptoms |
-.279; -.255 | — |
| SECONDARY Dyspnea Characteristics |
.029; .272 | — |
| SECONDARY Respiratory-related Symptoms |
11.4; 7.6 | — |
| SECONDARY rPFT Adherence |
82.2 | — |
| SECONDARY Dyspnea Functional Limitations |
-.022; -.255 | — |
| SECONDARY Sleep Related Impairment |
.095; .140 | — |
Eligibility Criteria
Inclusion Criteria
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT04490148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.