Clinical trial NCT03214224: Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)
Official title: Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS
Keywords: Telemedicine
Pulmonary Function Testing
Telehealth
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A self-controlled validation study of experimental remote PFT assessment vs standard of care (non-randomized)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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. The central hypothesis is that guided home assessment of respiratory function is a valid method for detecting respiratory insufficiency leading to noninvasive ventilation (NIV) recommendation. This study has the potential to transform the current practice of conducting breathing assessments every three months, resulting in timelier detection of respiratory insufficiency, thereby staining quality of life and lengthening survival. This protocol has the potential to demonstrate telemanagement exceeding the standards of ALS care.

This is a self-controlled study which will enroll 40 patients from the ALS clinic. On the day of their clinical visit, study participants will perform both a standard PFT as well as a simulated rPFT, both generating three valid repetitions of forced vital capacity (FVC) and maximal inspiratory pressure (MIP) procedures. The simulated rPFT will mimic the practice of home telemonitoring by having patients be instructed by a respiratory therapist over the telemanagement portal while in a research room within the ALS clinic. The primary hypothesis is that there is no difference in the results of PFT and rPFT for respiratory assessment of FVC and MIP.

Eligibility criteria: Inclusion Criteria:

* Part 1

Patients:

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

Caregivers:

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

Respiratory Therapist

1. Be a member of the Hershey Medical Center ALS multidisciplinary care team.
2. 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:

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).

Exclusion Criteria:

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

Patients:

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

Caregivers: None

Respiratory Therapists: None

Primary outcomes:
measure: Standard PFT - Forced Vital Capacity
timeFrame: One administration - 10 minutes
measure: Standard PFT - Maximal Inspiratory Pressure
timeFrame: One administration - 10 minutes
measure: Remote PFT - Forced Vital Capacity
timeFrame: One administration - 10 minutes
measure: Remote PFT - Maximal Inspiratory Pressure
timeFrame: One administration - 10 minutes
Secondary outcomes:
measure: Patient and Caregiver Reported Outcomes
timeFrame: 10 minute survey administered following completion of standard and remote PFT of Part 1
measure: Therapist Reported Outcomes
timeFrame: 10 minute survey administered following completion of standard and remote PFT of Part 1
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center ALS Clinic
state: Pennsylvania
Study officials:
References: