Remote Pulmonary Function Testing and Nurse Coaching in ALS

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04490148

Collaborator

ALS Association (Other)

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ALS	Device: remote pulmonary function testing Device: standard pulmonary function testing Behavioral: Nurse Respiratory Health Coaching (NRHC)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.	Device: remote pulmonary function testing Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP) Device: standard pulmonary function testing 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.	Device: remote pulmonary function testing Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP) Device: standard pulmonary function testing Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP) Behavioral: Nurse Respiratory Health Coaching (NRHC) 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.

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.

Device: remote pulmonary function testing

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

Device: standard pulmonary function testing

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

Device: remote pulmonary function testing

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

Device: standard pulmonary function testing

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

Behavioral: Nurse Respiratory Health Coaching (NRHC)

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.

Outcome Measures

Primary Outcome Measures

Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring [1 year]
Date of identification of NIV need from rPFT monitoring
Date of identification of NIV need from standard PFT monitoring [1 year]
Date of identification of NIV need from standard PFT monitoring
Self-efficacy [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.

Secondary Outcome Measures

Respiratory-related quality of life [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.
Respiratory-related medical complications [1 year]
Also included in the respiratory questionnaire are seven questions regarding respiratory complications experienced in the previous month.
rPFT Adherence [1 year]
Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hershey Medical Center ALS Clinic	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center
ALS Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zachary Simmons, Professor of Neurology and Humanities, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT04490148

Other Study ID Numbers:

STUDY00006924part2

First Posted:

Jul 28, 2020

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Zachary Simmons, Professor of Neurology and Humanities, Milton S. Hershey Medical Center

Telemedicine

Pulmonary Function Testing

Telehealth

Study Results

No Results Posted as of Jul 14, 2022