Chronic Obstructive Pulmonary DiseaseNCT05009485
A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP
A study testing Current Health platform in people with Chronic Obstructive Pulmonary Disease and Community-acquired Pneumonia, run by Current Health.
Trial summary
Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia
- What is being tested?
- Current Health platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years or older
- confirmed diagnosis of moderate-severe COPD or community acquired pneumonia
- attendance at South Shore Hospital with an exacerbation of COPD / CAP
- fit for discharge to home
Who cannot join
- suspicion of COVID-19 or confirmed COVID-19 positive
- life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours)
- unable/unwilling to use Current Health
- bilateral axillary lymph node dissection
- persistent atrial fibrillation
- heavy tattooing on upper arms
- discharged to skilled nursing facility
- no access to home or mobile telephone
About this study
Official title: A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia
Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.
- Being tested
- Current Health platform
- Keywords
- wearable, Current Health platform, 30 day readmission
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Health platformDevice
A remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly. Receives: Device: Current Health platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a hospital readmission
Measured: up to 30 days
Secondary outcomes (6)
Time to service use
Measured: up to 30 days
Rate of clinical visits
telehealth and/or ambulatory visits
Measured: up to 30 days
Length of Stay
original and subsequent readmissions or emergency department attendance
Measured: up to 30 days
Rate of Mortality
Measured: up to 30 days
Rate of medication adherence
Measured: up to 30 days
Progression of Disease
medication requirements, oxygen dependence, spirometric changes
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: study never started because reprioritization of clinical research efforts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Current Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Shore Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009485
- Sponsor's protocol ID
- SSH_2021
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05009485
- Acronym / sponsor ID
- SSH_2021
- Keywords
- wearable, Current Health platform, 30 day readmission
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started because reprioritization of clinical research efforts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Current HealthIndustry (pharma, biotech, devices)
- Collaborators
- South Shore Hospital
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Current Health platformParticipants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years or older
- confirmed diagnosis of moderate-severe COPD or community acquired pneumonia
- attendance at South Shore Hospital with an exacerbation of COPD / CAP
- fit for discharge to home
Key exclusion criteria (8 listed)
- suspicion of COVID-19 or confirmed COVID-19 positive
- life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours)
- unable/unwilling to use Current Health
- bilateral axillary lymph node dissection
- persistent atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current Health platformA remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count. | Device | Intervention |
Primary outcome
Number of participants with a hospital readmission
Time frame: up to 30 days
6 secondary outcomes
Time to service use
Time frame: up to 30 days
Rate of clinical visits
Time frame: up to 30 days
Length of Stay
Time frame: up to 30 days
Rate of Mortality
Time frame: up to 30 days
Rate of medication adherence
Time frame: up to 30 days
Progression of Disease
Time frame: up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Current Health platform in people with Chronic Obstructive Pulmonary Disease and Community-acquired Pneumonia, run by Current Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a hospital readmission (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.