N/A N=49 Health Services Research

Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

ALS

Bottom Line

View on ClinicalTrials.gov: NCT03214224 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Standard PFT - Forced Vital Capacity — 72.7 Percent Predicted FVC

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: remote pulmonary function testing (Device); standard pulmonary function testing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Standard PFT - Forced Vital Capacity	72.7	—
PRIMARY Standard PFT - Maximal Inspiratory Pressure	-68.7	—
PRIMARY Remote PFT - Forced Vital Capacity	79.7	—
PRIMARY Remote PFT - Maximal Inspiratory Pressure	-66.2	—
SECONDARY Patient and Caregiver Reported Outcomes	4.50; 4.45; 4.48	—
SECONDARY Therapist Reported Outcomes	4.16; 3.75; 4.04	—

Summary

The specific objective of this study is to validate the practice of remote pulmonary function testing (rPFT) conducted in the home through the use of connected mobile health devices and the Penn State Hershey ALS Telemanagement program.

Eligibility Criteria

Inclusion Criteria

Part 1

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

Caregivers:

Be 18 years of age or older, of either gender.
Be able and willing to provide informed consent.

Respiratory Therapist

Be a member of the Hershey Medical Center ALS multidisciplinary care team.
Be able and willing to provide verbal informed consent after receiving a summary explanation of research (SER).

Part 2 imposes additional inclusion criteria for patients only.

Patients:

Symptom onset within the last three years. 5) 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).

Exclusion Criteria

Exclusion criteria are the same for both parts of the study.

Patients:

Use of NIV or diaphragm pacer at time of obtaining informed consent.
FVC ≤50% predicted or MIP > -60 cm H2O.
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

Respiratory Therapists: None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03214224). 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.