COPDGASSPNCT03879291
Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
An observational study of COPD and Pulmonary Rehabilitation, run by Karen Larimer at 1 site in United States.
Trial summary
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Pulmonary Rehabilitation
- What is being tested?
- pinpointIQ
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 30 Dec 2019
- Phase
- Observational
- 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 40 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be patients diagnosed with COPD participating in a pulmonary rehabilitation program.
Who may be able to join
- Male or female, at least 40 years of age;
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
- Enrolled in the study site's 12-week pulmonary rehabilitation program;
- Capable of completing a 6-minute walk test;
- Willing and able to comply with scheduled protocol procedures and follow up;
- Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial.
Who cannot join
- Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed;
- Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results;
- Patients who have implanted defibrillators or pacemakers;
- Patient is allergic to hydrocolloid adhesive;
- Patient does not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University Health System
Evanston, Illinois, 60201
About this study
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program.
It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.
- Conditions
- COPD, Pulmonary Rehabilitation
- Being tested
- pinpointIQ
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pinpointIQOther
The study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility
Correlation of reported health events with the multivariate change index
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start9 Jan 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Larimer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sunovian
- Responsible party
- Sponsor-investigator, Karen Larimer, physIQ, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879291
- Sponsor's protocol ID
- CTP-010
- Acronym
- GASSP
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT03879291
- Acronym / sponsor ID
- GASSP / CTP-010
- Conditions
- COPD, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Karen LarimerIndustry (pharma, biotech, devices)
- Collaborators
- Sunovian
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Mar 2019 (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.
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program.
It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients diagnosed with COPD participating in a pulmonary rehabilitation program.
Key inclusion criteria (6 listed)
- Male or female, at least 40 years of age;
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
- Enrolled in the study site's 12-week pulmonary rehabilitation program;
- Capable of completing a 6-minute walk test;
- Willing and able to comply with scheduled protocol procedures and follow up;
Key exclusion criteria (5 listed)
- Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed;
- Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results;
- Patients who have implanted defibrillators or pacemakers;
- Patient is allergic to hydrocolloid adhesive;
- Patient does not speak English.
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 |
|---|---|---|
| pinpointIQThe study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline | Other | – |
Primary outcome
Clinical Utility
Time frame: 90 days
Correlation of reported health events with the multivariate change index
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pulmonary Rehabilitation, run by Karen Larimer at 1 site in United States.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Clinical Utility (time frame: 90 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 16 Mar 2020.