Study Purpose:
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.Study Status:
Not recruiting
Disease:
ALS
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
remote pulmonary function testing, standard pulmonary function testing
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Hershey, Pennsylvania, United States
Full Study 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. 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.
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.
Study Sponsor:
Milton S. Hershey Medical Center
Estimated Enrollment:
49
Estimated Study Start Date:
11 / 01 / 2017
Estimated Study Completion Date:
09 / 30 / 2019
Posting Last Modified Date:
08 / 07 / 2020
Date Study Added to neals.org:
07 / 11 / 2017
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania
17033
United States