ALSNCT03214224
Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)
A study testing remote pulmonary function testing and standard pulmonary function testing in people with ALS, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALS
- What is being tested?
- remote pulmonary function testing and standard pulmonary function testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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:
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- ALS
- Being tested
- remote pulmonary function testing, standard pulmonary function testing
- Keywords
- Telemedicine, Pulmonary Function Testing, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote pulmonary function testingDevice
Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testingDevice
Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
| Study group | Role | What they receive |
|---|---|---|
| remote PFT (rPFT) validation | Experimental | Subjects in this arm perform both standard and remote PFT assessments in order to validate the procedure. Receives: Device: remote pulmonary function testing; Device: standard pulmonary function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard PFT - Forced Vital Capacity
Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome.
Measured: One administration - 10 minutes
Standard PFT - Maximal Inspiratory Pressure
Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome.
Measured: One administration - 10 minutes
Remote PFT - Forced Vital Capacity
Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid FVC maneuvers. The best FVC value is the outcome.
Measured: One administration - 10 minutes
Remote PFT - Maximal Inspiratory Pressure
Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid MIP maneuvers. The best MIP value is the outcome.
Measured: One administration - 10 minutes
Secondary outcomes (2)
Patient and Caregiver Reported Outcomes
Survey responses from the patient/caregiver pair. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability.
Subscales (evaluated separately):
General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]
Measured: 10 minute survey administered following completion of standard and remote PFT of Part 1
Therapist Reported Outcomes
Survey responses from the respiratory therapist. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability.
Subscales (evaluated separately):
General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]
Measured: 10 minute survey administered following completion of standard and remote PFT of Part 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Nov 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A self-controlled validation study of experimental remote PFT assessment vs standard of care (non-randomized)
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Simmons, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214224
- Sponsor's protocol ID
- STUDY00006924part1
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2017
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan at this time to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)
- ClinicalTrials.gov ID
- NCT03214224
- Acronym / sponsor ID
- STUDY00006924part1
- Conditions
- ALS
- Keywords
- Telemedicine, Pulmonary Function Testing, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A self-controlled validation study of experimental remote PFT assessment vs standard of care (non-randomized)
| Arm | Type | Receives |
|---|---|---|
| remote PFT (rPFT) validation | Experimental | Device: remote pulmonary function testing, Device: standard pulmonary function testingSubjects in this arm perform both standard and remote PFT assessments in order to validate the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part 1
- 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
- Be 18 years of age or older, of either gender.
Key exclusion criteria (8 listed)
- Exclusion criteria are the same for both parts of the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote pulmonary function testingTelemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP) | Device | remote PFT (rPFT) validation |
| standard pulmonary function testingStandard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP) | Device | remote PFT (rPFT) validation |
Primary outcome
Standard PFT - Forced Vital Capacity
Time frame: One administration - 10 minutes
Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome.
Standard PFT - Maximal Inspiratory Pressure
Time frame: One administration - 10 minutes
Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome.
Remote PFT - Forced Vital Capacity
Time frame: One administration - 10 minutes
Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid FVC maneuvers. The best FVC value is the outcome.
Remote PFT - Maximal Inspiratory Pressure
Time frame: One administration - 10 minutes
Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid MIP maneuvers. The best MIP value is the outcome.
2 secondary outcomes
Patient and Caregiver Reported Outcomes
Time frame: 10 minute survey administered following completion of standard and remote PFT of Part 1
Therapist Reported Outcomes
Time frame: 10 minute survey administered following completion of standard and remote PFT of Part 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan at this time to share data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote pulmonary function testing and standard pulmonary function testing in people with ALS, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard PFT - Forced Vital Capacity (time frame: One administration - 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.