Remote Pulmonary Function Testing and Nurse Coaching in ALS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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ALS

Intervention / Treatment
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* Device: remote pulmonary function testing
* Device: standard pulmonary function testing
* Behavioral: Nurse Respiratory Health Coaching (NRHC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A longitudinal parallel group study of repeated measures of remote PFTs, nurse coaching, and their impact on respiratory outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remote PFT (rPFT) longitudinal<br>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<br>* Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)<br>Device: standard pulmonary function testing<br>* Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)<br>|
| Experimental: remote PFT (rPFT) + Nurse Coaching longitudinal<br>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<br>* Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)<br>Device: standard pulmonary function testing<br>* Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)<br>Behavioral: Nurse Respiratory Health Coaching (NRHC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring | Date of identification of NIV need from rPFT monitoring | 1 year | 
| Date of identification of NIV need from standard PFT monitoring | Date of identification of NIV need from standard PFT monitoring | 1 year | 
| Self-efficacy | 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 | 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 | Also included in the respiratory questionnaire are seven questions regarding respiratory complications experienced in the previous month. | 1 year | 
| rPFT Adherence | Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Pulmonary Function Testing, Telehealth