Mobile Cardiovascular Risk Service Trial
mCVRS
Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners
1 other identifier
interventional
80
1 country
2
Brief Summary
Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Sep 2017
Shorter than P25 for not_applicable cardiovascular-diseases
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2017
CompletedFirst Posted
Study publicly available on registry
March 16, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedOctober 11, 2018
October 1, 2018
12 months
March 10, 2017
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
4 months post enrollment
Mean number of contacts with a pharmacist
Mean number of contacts with a pharmacist
4 months post enrollment
Secondary Outcomes (1)
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
4 months post enrollment
Study Arms (2)
Web and mobile app access
EXPERIMENTALSubjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data.
Web app only access
ACTIVE COMPARATORSubjects will have access to the web-app version of the study Personal Health Record (and not the mobile app version) to communicate with the study pharmacist and enter and track their health data.
Interventions
CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.
Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.
Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
Eligibility Criteria
You may qualify if:
- Patients age 55 and older;
- Owns and uses a smartphone;
- Any ONE of the following guideline-related needs in the past 18 months:
- Most recent encounter LDL \>= 100 mg/dl
- Most recent encounter BP \> 140/90 mmHg (or \> 150/90 for persons age 60+)
- Most recent encounter not taking recommended post-stroke medications
- Most recent encounter not taking recommended post-MI medications
- Diabetics with most recent encounter not on ACE inhibitor or ARB blocker
- Any patient with most recent A1c \> 8.0%
- Diabetics with no urine microalbumin screening, past 18 months
You may not qualify if:
- Non-English speaking (app available only in English for this study)
- No encounter in the past 18 months (they may be receiving care elsewhere and guideline-related needs may not be reliably assessed) at the clinic itself
- Most recent systolic BP \>200 or diastolic BP \> 110 mm Hg
- Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST \> 3 times normal (either AST above 96 U/L or ALT above 99 U/L or total bilirubin \> 2.0 mg/dl))
- History of hemorrhagic stroke
- Pulmonary hypertension
- Stage 4 or metastatic cancer
- Current nursing home residence or has plans to move to one within the next 12 months
- Has plans to transfer care from the current clinic within the next 6 months
- Inability to give informed consent or impaired cognitive function
- Currently pregnant (females only)
- Currently a prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Siouxland Community Health Center
Sioux City, Iowa, 51105, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Chrischilles, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 10, 2017
First Posted
March 16, 2017
Study Start
September 1, 2017
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
Public use data sets will be created and made available to other investigators in a timely manner. Data will only be provided in the form of fully HIPAA-de-identified datasets. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All categorical demographic variables will be collapsed into categories large enough so that combinations of demographic categories for age, gender or area of residence will have 10 or more individuals in each cell. The investigators plan to create SAS datasets in transport format and provide data dictionaries describing the contents of each dataset. Investigators requesting access to the data will be asked to complete a data sharing agreement.