Peripheral Arterial DiseaseNCT03898570
Distributed Registry
An observational study of Peripheral Arterial Disease and Intermittent Claudication, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication, Arteriosclerosis
- What is being tested?
- Patient reported outcomes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 1 Mar 2021
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults with an iPhone 5s or higher who can read English
Who may be able to join
- Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
- Patients with smartphones (iOS or Android) with unlimited data plans.
- Patients who agree to remote surveillance
Who cannot join
- Patients unwilling to download a research study app.
- Data plans which are not unlimited.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto Veterans Hospital
Palo Alto, California, 94305
Stanford
Palo Alto, California, 94588
About this study
Official title: Distributed Registry Study
The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Arteriosclerosis, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Being tested
- Patient reported outcomes
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Arteriosclerosis, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reported outcomesBehavioural
Patients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone.
Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing vascular surgery procedures | Patients will report outcomes via their smartphone. Receives: Behavioral: Patient reported outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes (PROs) using mobile app
PROs are any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Oliver O Aalami, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898570
- Sponsor's protocol ID
- IRB-47517
- Status last verified
- May 2023
- First submitted
- 29 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distributed Registry Study
- ClinicalTrials.gov ID
- NCT03898570
- Acronym / sponsor ID
- IRB-47517
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Arteriosclerosis, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 2 Apr 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 purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing vascular surgery procedures | – | Behavioral: Patient reported outcomesPatients will report outcomes via their smartphone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with an iPhone 5s or higher who can read English
Key inclusion criteria (3 listed)
- Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
- Patients with smartphones (iOS or Android) with unlimited data plans.
- Patients who agree to remote surveillance
Key exclusion criteria (2 listed)
- Patients unwilling to download a research study app.
- Data plans which are not unlimited.
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 |
|---|---|---|
| Patient reported outcomesPatients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone. Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys | Behavioural | Patients undergoing vascular surgery procedures |
Primary outcome
Patient Reported Outcomes (PROs) using mobile app
Time frame: 1 Year
PROs are any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Oliver O Aalami, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Intermittent Claudication, run by Stanford University at 2 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Reported Outcomes (PROs) using mobile app (time frame: 1 Year). 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 10 May 2023.