- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490148
Remote Pulmonary Function Testing and Nurse Coaching in ALS
March 22, 2023 updated by: Zachary Simmons, MD, Milton S. Hershey Medical Center
Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis
Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary function testing (rPFT) with or without the additional support of nurse coaching.
This is a randomized controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory function can lead to timelier initiation of NIV and 2) whether structured nurse coaching leads to improved self-efficacy for managing disease and better maintenance of respiratory health.
For enrollees in both arms, standard FVC and MIP measurements obtained approximately every three months by the respiratory therapist during ALS Clinic are supplemented with self-administered rPFTs performed weekly.
Enrollees in the rPFT+NRHC (nurse respiratory health coaching) arm will additionally receive monthly coaching with the study nurse via telehealth.
Outcomes include measures of quality of life and self-efficacy for managing disease.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew Geronimo, PhD
- Phone Number: 282576 717-531-0003
- Email: geronimo@psu.edu
Study Contact Backup
- Name: Abid Kazi, PhD
- Phone Number: 282465 717-531-0003
- Email: akazi@pennstatehealth.psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Hershey Medical Center ALS Clinic
-
Contact:
- Andrew Geronimo, PhD
- Phone Number: 282576 717-531-0003
- Email: ageronimo@pennstatehealth.psu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- Symptom onset within the last three years.
- 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).
Caregivers:
- Be 18 years of age or older, of either gender.
- Be able and willing to provide informed consent.
Exclusion Criteria:
Patients:
- Use of NIV or diaphragm pacer at time of obtaining informed consent.
- FVC ≤50% predicted or MIP > -60 cm of water.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: remote PFT (rPFT) longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure.
They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
|
Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
|
Experimental: remote PFT (rPFT) + Nurse Coaching longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure.
They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
|
Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. [Bennett2010], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring
Time Frame: 1 year
|
Date of identification of NIV need from rPFT monitoring
|
1 year
|
Date of identification of NIV need from standard PFT monitoring
Time Frame: 1 year
|
Date of identification of NIV need from standard PFT monitoring
|
1 year
|
Self-efficacy
Time Frame: 1 year
|
The self-efficacy assessment contains questions from the PROMIS item banks on Self-Efficacy for Managing Symptoms (9 items), Self-Efficacy for Managing Social Interactions (5 items), and Self-Efficacy for Managing Medications and Treatments (4 items).
These assessment tools, designed for use in chronic conditions, are scored as an average of individual components on a 1-5 scale.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory-related quality of life
Time Frame: 1 year
|
The respiratory questionnaire contains three Patient-Reported Outcomes Measurement Information System (PROMIS) sub-scales on Dyspnea Characteristics (5 items), Dyspnea Functional Limitations (10 items), and Sleep Related Impairment (8 items).
The PROMIS sub-scales, all of which utilize Likert-type scaling, will be summed as composite scores, with higher numbers indicating poorer quality of life.
|
1 year
|
Respiratory-related medical complications
Time Frame: 1 year
|
Also included in the respiratory questionnaire are seven questions regarding respiratory complications experienced in the previous month.
|
1 year
|
rPFT Adherence
Time Frame: 1 year
|
Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00006924part2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan at this time to share data with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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