Cardiovascular DiseasesmCVRSNCT03081871
Mobile Cardiovascular Risk Service Trial
A study testing Pharmacist-led cardiovascular risk service (CVRS), Mobile access to study Personal Health Record and Web access to study Personal Health Record in people with Cardiovascular Diseases and Personal Health Records, run by University of Iowa at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Cardiovascular Diseases, Personal Health Records, Pharmaceutical Care
- What is being tested?
- Pharmacist-led cardiovascular risk service (CVRS), Mobile access to study Personal Health Record and Web access to study Personal Health Record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 31 Aug 2018
- 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 55 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Siouxland Community Health Center
Sioux City, Iowa, 51105
About this study
Official title: Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners
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.
Read the detailed description
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature.
The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, the investigators will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. The study team will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. The central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US.
The primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence-based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. The investigators postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group.
This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline-concordant therapy.
- Being tested
- Pharmacist-led cardiovascular risk service (CVRS), Mobile access to study Personal Health Record, Web access to study Personal Health Record
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led cardiovascular risk service (CVRS)Other
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.
Mobile access to study Personal Health RecordOther
Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.
Web access to study Personal Health RecordOther
Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
| Study group | Role | What they receive |
|---|---|---|
| Web and mobile app access | Experimental | Subjects 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. Receives: Other: Pharmacist-led cardiovascular risk service (CVRS); Other: Mobile access to study Personal Health Record; Other: Web access to study Personal Health Record |
| Web app only access | Active comparator | Subjects 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. Receives: Other: Pharmacist-led cardiovascular risk service (CVRS); Other: Web access to study Personal Health Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months post enrollment
Mean number of contacts with a pharmacist
Mean number of contacts with a pharmacist
Measured: 4 months post enrollment
Secondary outcomes (1)
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Measured: 4 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Sep 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A Chrischilles, University of Iowa
- Investigators
- Elizabeth Chrischilles, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081871
- Sponsor's protocol ID
- 201603819
- Acronym
- mCVRS
- Status last verified
- Oct 2018
- First submitted
- 10 Mar 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners
- ClinicalTrials.gov ID
- NCT03081871
- Acronym / sponsor ID
- mCVRS / 201603819
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 16 Mar 2017 (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 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.
Detailed description
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature.
The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, the investigators will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. The study team will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. The central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US.
The primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence-based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. The investigators postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group.
This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline-concordant therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web and mobile app access | Experimental | Other: Pharmacist-led cardiovascular risk service (CVRS), Other: Mobile access to study Personal Health Record, Other: Web access to study Personal Health RecordSubjects 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 comparator | Other: Pharmacist-led cardiovascular risk service (CVRS), Other: Web access to study Personal Health RecordSubjects 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. |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients age 55 and older;
- Owns and uses a smartphone;
- Any ONE of the following guideline-related needs in the past 18 months:
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Pharmacist-led cardiovascular risk service (CVRS)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. | Other | Web and mobile app access, Web app only access |
| Mobile access to study Personal Health RecordOnly subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record. | Other | Web and mobile app access |
| Web access to study Personal Health RecordSubjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record. | Other | Web and mobile app access, Web app only access |
Primary outcome
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Time frame: 4 months post enrollment
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Mean number of contacts with a pharmacist
Time frame: 4 months post enrollment
Mean number of contacts with a pharmacist
1 secondary outcome
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Time frame: 4 months post enrollment
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 11 Oct 2018.
- Individual participant dataSharing planned: Yes. 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.
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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.
Elizabeth Chrischilles, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led cardiovascular risk service (CVRS), Mobile access to study Personal Health Record and Web access to study Personal Health Record in people with Cardiovascular Diseases and Personal Health Records, run by University of Iowa 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 10 inclusion and 12 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 11 Oct 2018. 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?
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site) (time frame: 4 months post enrollment). The study lists 2 primary outcomes in all. 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 11 Oct 2018.