Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03214224
Other study ID # STUDY00006924part1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date September 30, 2019

Study information

Verified date July 2020
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 suf?cient 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
remote pulmonary function testing
Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing
Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

Locations

Country Name City State
United States Hershey Medical Center ALS Clinic Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard PFT - Forced Vital Capacity Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome. One administration - 10 minutes
Primary Standard PFT - Maximal Inspiratory Pressure Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome. One administration - 10 minutes
Primary 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. One administration - 10 minutes
Primary 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. One administration - 10 minutes
Secondary 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)]
10 minute survey administered following completion of standard and remote PFT of Part 1
Secondary 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)]
10 minute survey administered following completion of standard and remote PFT of Part 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Completed NCT02405182 - MRI Biomarkers in ALS
Completed NCT00696332 - Talampanel for Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT03865420 - Amyotrophic Lateral Sclerosis (ALS) Families Project
Terminated NCT04054141 - rTMS in Treatment of Spasticity N/A
Recruiting NCT03272503 - A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT05568615 - Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS Phase 3
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Active, not recruiting NCT04259255 - Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Recruiting NCT02495571 - Assessment of Voluntary and Reflex Cough in Patients With ALS N/A
Completed NCT02525471 - A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS) Phase 1
Recruiting NCT05031351 - NF-κB Inhibition in Amyotrophic Lateral Sclerosis Phase 2
Active, not recruiting NCT05581771 - Factors Associated With Success of NIPPV in ALS Patients
Active, not recruiting NCT03268603 - Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT05271435 - Digital Tools for Assessment of Motor Functions and Falls in ALS
Completed NCT06005506 - National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function. N/A
Recruiting NCT04138095 - Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care N/A
Recruiting NCT03698149 - ECoG BMI for Motor and Speech Control N/A
Not yet recruiting NCT05621213 - Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation N/A
Terminated NCT03373981 - Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS N/A