Remote Pulmonary Function Testing and Nurse Coaching in ALS

NCT04490148 | Completed Results FDA Device

• 1 other identifier: STUDY00006924part2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ALS

Keywords

Telemedicine; Pulmonary Function Testing; Telehealth

Outcome Measures

Primary Outcomes (5)

• Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring

  NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of remote measurement of FVC 50% or less of the predicted value is reported here.

  1 year

• Date of Identification of NIV Need From Standard PFT Monitoring

  NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of standard, in-clinic measurement of FVC 50% or less of the predicted value is reported here.

  From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 years

• Self-efficacy for Managing Medications and Treatments

  The self-efficacy assessment contains questions from the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks on Self-Efficacy for Managing Medications and Treatments (4 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.

  1 year

• Self-efficacy for Managing Social Interactions

  The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Social Interactions (5 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.

  1 year

• Self-efficacy for Managing Symptoms

  The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Symptoms (9 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.

  1 year

Secondary Outcomes (5)

• Dyspnea Characteristics

  1 year

• Respiratory-related Symptoms

  1 year

• rPFT Adherence

  1 year

• Dyspnea Functional Limitations

  1 year

• Sleep Related Impairment

  1 year

Study Arms (2)

remote PFT (rPFT) longitudinal

ACTIVE COMPARATOR

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.

Device: remote pulmonary function testing; Device: standard pulmonary function testing

remote PFT (rPFT) + Nurse Coaching longitudinal

EXPERIMENTAL

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.

Device: remote pulmonary function testing; Device: standard pulmonary function testing; Behavioral: Nurse Respiratory Health Coaching (NRHC)

Interventions

remote pulmonary function testing DEVICE

Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

remote PFT (rPFT) + Nurse Coaching longitudinal; remote PFT (rPFT) longitudinal

standard pulmonary function testing DEVICE

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

remote PFT (rPFT) + Nurse Coaching longitudinal; remote PFT (rPFT) longitudinal

Nurse Respiratory Health Coaching (NRHC) BEHAVIORAL

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.

remote PFT (rPFT) + Nurse Coaching longitudinal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• ALS Association: collaborator

Study Sites (1)

Hershey Medical Center ALS Clinic

Hershey, Pennsylvania, 17033, United States

Location

Results Point of Contact

• Title: Dr. Andrew Geronimo
• Organization: Penn State College of Medicine

ageronimo@pennstatehealth.psu.edu

717 531 0003

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Humanities

Model Details: A longitudinal parallel group study of repeated measures of remote PFTs, nurse coaching, and their impact on respiratory outcomes.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 24, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)