Clinical trial NCT04490148: Remote Pulmonary Function Testing and Nurse Coaching in ALS
Official title: Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS
Keywords: Telemedicine
Pulmonary Function Testing
Telehealth
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2020-07-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A longitudinal parallel group study of repeated measures of remote PFTs, nurse coaching, and their impact on respiratory outcomes.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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
4. Symptom onset within the last three years.
5. Have a computer and home internet service sufficient 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).

Caregivers:

1. Be 18 years of age or older, of either gender.
2. Be able and willing to provide informed consent.

Exclusion Criteria:

Patients:

1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
2. FVC ≤50% predicted or MIP \> -60 cm of water.
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

Primary outcomes:
measure: Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring
timeFrame: 1 year
measure: Date of Identification of NIV Need From Standard PFT Monitoring
timeFrame: From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 years
measure: Self-efficacy for Managing Medications and Treatments
timeFrame: 1 year
measure: Self-efficacy for Managing Social Interactions
timeFrame: 1 year
measure: Self-efficacy for Managing Symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Dyspnea Characteristics
timeFrame: 1 year
measure: Respiratory-related Symptoms
timeFrame: 1 year
measure: rPFT Adherence
timeFrame: 1 year
measure: Dyspnea Functional Limitations
timeFrame: 1 year
measure: Sleep Related Impairment
timeFrame: 1 year
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center ALS Clinic
state: Pennsylvania
Study officials:
References: