Clinical trial NCT04406532: Home-Based Covid-19 Rehabilitation Program
Official title: Home Based Covid-19 Rehabilitation Program: Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid-19
Keywords: rehabilitative medicine
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim is to conduct a pilot single-blind randomized controlled trial to examine the preliminary efficacy of a 14 day app-based pulmonary and mobility focused rehabilitation program (intervention arm) versus a self-guided exercise program (active control arm) on pulmonary and functional outcomes in 100 patients tested for COVID-19 infection and isolated at home.

Detailed description: As of April 20, 2020, there had been over 2.4 million confirmed cases of coronavirus disease 2019 (COVID-19) reported globally; 759,786 cases in USA. Triage protocols have been developed to prioritize individuals for COVID-19 testing based on exposure or symptoms. Due to the high demand for screening, the turnaround time for results in our area varies from 5-6 days. While current estimates suggest that 80% of individuals will have mild illness, there is no reliable way to predict course. Also some patients may rapidly deteriorate a week after illness onset. No proven preventive or therapeutic options are yet available for individuals with mild symptoms who are tested for COVID-19 infection, and asked to self-isolate themselves at home while awaiting results.

COVID-19 is mainly a respiratory disease. Complications such as pneumonia and acute respiratory distress syndrome (ARDS) are among its most dreaded complications, and major contributors to Intensive Care Unit admissions and mortality. Early studies show that dyspnea occurs at a median of 6 days after initial symptom onset, which can progress to ARDS at a median of 12 days after onset. Hence, there is a window of 3-4 days after symptom onset (corresponds to the time individuals typically wait for test results) that interventions could be applied to prevent progression. Pulmonary and functional rehabilitation has proven validity in preventing worsening of pulmonary and physical function in respiratory diseases. But the utility of rehabilitation has not yet been established in the COVID-19 patient population.

Based on our research in frail older adults and input from experts, the investigators recently developed and published an innovative stratified self-guided care and exercise manual for patients with COVID-19 infection to improve pulmonary function and prevent immobility. The investigators build on this experience to test the efficacy of a telephone-based app (PT-Pal™) version of this pulmonary and mobility focused rehabilitation program. The PT-Pal is a validated cloud-based patient engagement platform that enables management of patient care by sending treatment plans, surveys and reminders to the patient's mobile device using HIPAA compliant secure messaging.

Our aim is to conduct a pilot single-blind randomized controlled trial in 100 patients tested for COVID-19 infection and isolated at home who will be randomized into either a 14 day PT-Pal pulmonary and mobility focused rehabilitation program or a self-guided exercise group. Compared to participants in the active control group, the investigators hypothesize that participants in the PT-Pal program will show lesser declines in self-reported pulmonary (St George's Respiratory questionnaire) and physical function (AM-PAC basic mobility questionnaire) due to greater participation and adherence rates. The investigators will test at baseline, day and day 14 to determine trajectories in both groups. All outcomes will be collected remotely as social distancing precludes in-person testing. At our recruitment site, 40-45% of individuals tested for COVID-19 had a positive result, but given current delays in obtaining results (5-6 days), the investigators will enroll participants before knowing their COVID-19 status.

The investigators will also examine the following secondary outcomes obtained remotely: Pulmonary function (breath holding and peak flow), Physical function (5 times sit to stand test), Health events (Emergency Room visits, hospitalizations), Psychological (anxiety/depressive symptoms), and Feasibility metrics (sessions completed).

Our pilot clinical trial will build the evidence base for a rehabilitative approach to be applied alongside emerging therapies to ameliorate the devastating pulmonary and physical function declines seen in COVID-19 infection. It can be implemented in the time window between presentation and development of severe symptoms in the large population of adults awaiting test results in the community. Our approach can also apply to COVID-19 patients such as those discharged from hospitals or healthcare workers furloughed home due to disease exposure.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older.
2. Symptoms suggestive of Covid-19 infection (fever, cough, chest discomfort or loss of smell/taste).
3. Covid-19 screening done.
4. Ambulatory without assistive devices (such as cane or walker).
5. Access to PT-Pal app via cellular phone, iPad or computer (e.g. Zoom™).

Exclusion Criteria:

1. Severe symptoms requiring referral to the Emergency Department.
2. Contraindications to exercise (cardiac disease such as diagnosed arrhythmias, on home oxygen, or end stage organ failure).
3. Known history of poorly controlled diabetes or hypertension.
4. Active neurological or psychiatric illnesses.

Primary outcomes:
measure: Change in pulmonary function (St George's Respiratory questionnaire: SGRQ)
timeFrame: baseline, at day 7 and at day 14
measure: Change in physical function (Activity Measure for Post-Acute Care: AM-PAC)
timeFrame: baseline, at day 7 and at day 14
Secondary outcomes:
measure: Change in pulmonary function (Sabrasez single breath count)
timeFrame: baseline, at day 7 and at day 14
measure: Change in pulmonary function (Peak flow tests)
timeFrame: baseline, at day 7 and at day 14
measure: Change in physical function (5 times site to stand test)
timeFrame: baseline, at day 7 and at day 14
measure: Health events (emergency room visits and hospitalizations)
timeFrame: baseline to day 14
measure: Change in psychological measures (Beck Anxiety Inventory: BAI)
timeFrame: baseline, at day 7 and at day 14
measure: Change in psychological measures (Center for Epidemiologic Studies Depression Scale: CES-D)
timeFrame: baseline, at day 7 and at day 14
measure: Feasibility (Adherence)
timeFrame: baseline to day 14
measure: Feasibility (Acceptability)
timeFrame: baseline to day 14
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joe Verghese, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Anne F Ambrose, MD
role: PRINCIPAL_INVESTIGATOR
References: