HypertensionvCCCNCT04585880
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline
A study testing Virtual Collaborative Care Clinic in people with Hypertension and Cognitive Decline, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Cognitive Decline
- What is being tested?
- Virtual Collaborative Care Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 2 Jul 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and older
- Active patient in participating primary care clinic
- Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity)
- Elevated blood pressure as defined by:
- Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit
- Sufficiently fluent in English to participate in study procedures
- Adequate vision and hearing to complete study procedures
Who cannot join
- Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
- End stage renal disease on dialysis
- Chronic active disease with expected life expectancy < 2 years as determined by the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66106
About this study
Official title: Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.
- Conditions
- Hypertension, Cognitive Decline
- Being tested
- Virtual Collaborative Care Clinic
- Keywords
- Hypertension, Cognitive Decline, Mild Cognitive Decline, Memory Loss, Memory Disorders, Memory Impairment, Blood Pressure, Blood Pressure, High
- Medical subject headings
- Hypertension, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Collaborative Care ClinicOther
The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care. Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician. As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Collaborative Care Clinic | Experimental | The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists. Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians. Receives: Other: Virtual Collaborative Care Clinic |
| Control Intervention | No intervention | The control intervention will consist of providing the participant with educational material and a home blood pressure monitor. The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists. Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review. Participants will continue to see their physicians for their usual care for blood pressure management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of system wide adoptability as assessed by survey responses
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Measured: Baseline
Feasibility of system wide adoptability as assessed by survey responses
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Measured: 3 Months Post Baseline
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Measured: Through study completion, an average of 9 months
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption. We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists. The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
Measured: Up to 2 months Post Baseline
Replicability to other health systems as assessed by survey responses
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Measured: Baseline
Replicability to other health systems as assessed by survey responses
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Measured: 3 Months Post Baseline
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Measured: Through study completion, an average of 9 months
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
vCCC Pharmacists will be asked for feedback on replicability to other health systems. We will conduct one-time semi-structured qualitative interviews including open-ended questions.
Measured: Up to 2 months Post Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start20 Oct 2020
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jeff Burns, MD, University of Kansas Medical Center
- Investigators
- Jeffrey Burns, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585880
- Sponsor's protocol ID
- STUDY146086
- Other IDs
- 1R61AG068483-01
- Acronym
- vCCC
- Status last verified
- Jul 2021
- First submitted
- 30 Sep 2020
- Last updated
- 9 Jul 2021
- Results posted
- 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
- ClinicalTrials.gov ID
- NCT04585880
- Acronym / sponsor ID
- vCCC / STUDY146086
- Conditions
- Hypertension, Cognitive Decline
- Keywords
- Hypertension, Cognitive Decline, Mild Cognitive Decline, Memory Loss, Memory Disorders, Memory Impairment, Blood Pressure, Blood Pressure, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 14 Oct 2020 (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.
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Collaborative Care Clinic | Experimental | Other: Virtual Collaborative Care ClinicThe Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists. Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians. |
| Control Intervention | No intervention | –The control intervention will consist of providing the participant with educational material and a home blood pressure monitor. The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists. Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review. Participants will continue to see their physicians for their usual care for blood pressure management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 and older
- Active patient in participating primary care clinic
- Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity)
- Elevated blood pressure as defined by:
- Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit
Key exclusion criteria (3 listed)
- Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
- End stage renal disease on dialysis
- Chronic active disease with expected life expectancy < 2 years as determined by the study team
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 |
|---|---|---|
| Virtual Collaborative Care ClinicThe vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care. Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician. As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure. | Other | Virtual Collaborative Care Clinic |
Primary outcome
Feasibility of system wide adoptability as assessed by survey responses
Time frame: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Feasibility of system wide adoptability as assessed by survey responses
Time frame: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Time frame: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Time frame: Up to 2 months Post Baseline
Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption. We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists. The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
Replicability to other health systems as assessed by survey responses
Time frame: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Replicability to other health systems as assessed by survey responses
Time frame: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Time frame: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
Time frame: Up to 2 months Post Baseline
vCCC Pharmacists will be asked for feedback on replicability to other health systems. We will conduct one-time semi-structured qualitative interviews including open-ended questions.
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 9 Jul 2021.
- 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.
Jeffrey Burns, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Collaborative Care Clinic in people with Hypertension and Cognitive Decline, run by University of Kansas Medical Center 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 7 inclusion and 3 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 9 Jul 2021. 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 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?
Feasibility of system wide adoptability as assessed by survey responses (time frame: Baseline). The study lists 8 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 9 Jul 2021.