Cardiovascular DiseaseNCT01133171
A Personalized Dashboard to Educate Veterans at Risk of Stroke
A study testing Nurse Alone and Dashboard Plus Nurse in people with Cardiovascular Disease and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Personalized risk communication methods have been used to educate patients that are at a high risk of developing cardiovascular disease. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease, Stroke
- What is being tested?
- Nurse Alone and Dashboard Plus Nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans receiving care from a Primary Care Clinic at the Roudebush VA Medical Center in Indianapolis with at least two of the following risk factors:
- Body Mass Index > 30
- Current Smoker
- Systolic Blood Pressure > 140 mm OR Diastolic Blood Pressure >90 mm
- Cholesterol LDL > 130 mg/dL
- Hemoglobin Hb1Ac > 8%
Who cannot join
- Subjects on Dialysis
- Subjects on Supplemental Oxygen
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
About this study
Personalized risk communication methods have been used to educate patients that are at a high risk of developing cardiovascular disease. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to self-manage their risk factors and observe the changes in risk by making lifestyle changes and modifying other risk factors by seeking medical advice.
This Rapid Response Project (RRP) builds upon these methods of communication by presenting the modifiable risk factors in the form of a personalized dashboard that highlights the contribution of these risk factors on the risk of developing a cardiovascular event. The modifiable risk factors that will be addressed in this study will include medical and lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation, diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.
Our primary goal is to develop a prototype of the dashboard to educate patients and help them make informed decisions in modifying their risk factors to reduce the probability of a cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by asking these patients to return after 6 months to determine if they have made any lifestyle changes or pursued medical intervention to reduce their cardiovascular risk. We will make qualitative observations on the knowledge retention of these patients while using the interactive dashboard.
Read the detailed description
Background:
Personalized risk communication methods have been used to educate patients who are at high risk of developing a cardiovascular event. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to use to compare the relative change in risk that might result from modifying their risk factors.
Objectives:
The goals of this pilot study were to: (a) develop a prototype of a personalized dynamic dashboard to educate veterans and help them make informed decisions about modifying their vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and tobacco use) to reduce the probability of a vascular event; (b) test the usability of this tool from the patient's perspective; and (c) provide preliminary data regarding the effectiveness of this tool in terms of changes in lifestyle or risk factor control compared with nurse-education.
Methods:
This was a three-arm randomized controlled study. Veterans from the panel of one experienced general internist were randomly assigned to one of three groups: (1) dashboard with nurse-education, (2) nurse-education alone, (3) usual care. To be eligible, patients must have had at least two of the following: body mass index >30 kg/m2; current tobacco use; systolic blood pressure >140 mm Hg or diastolic >90 mm Hg; LDL-cholesterol >130 mg/dL, or hemoglobin Hb1Ac >8%. We developed the dashboard in our Human Computer Interface/Information Technology laboratory. Patients in the dashboard group received two in-person counseling sessions regarding methods for controlling risk factors, and were asked to use the dashboard tool to enter values for their own risk factors and to observe the relative effects of varying their risk factor control on their overall vascular risk. The nurse-education consisted of two in-person counseling sessions regarding methods for controlling risk factors. Both intervention sessions lasted approximately 30 minutes; therefore, the majority of the time was used to interact with the tool in the dashboard group whereas the entire time was used for personalized risk factor discussion in the nurse-education group. For the usual care group, data were retrospectively collected about the primary care visits and laboratory tests which took place during the same period as the visits for intervention patients.
Status:
Completed.
- Conditions
- Cardiovascular Disease, Stroke
- Being tested
- Nurse Alone, Dashboard Plus Nurse
- Keywords
- Cardiovascular Disease, Stroke
- Medical subject headings
- Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse AloneBehavioural
Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
Dashboard Plus NurseBehavioural
Patients receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and were asked to use a computerized dashboard to enter values for the risk factors and observe the effects of the risk factors on the overall cardiovascular risk.
| Study group | Role | What they receive |
|---|---|---|
| Dashboard Plus Nurse | Experimental | Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling plus a computerized dashboard intervention. Receives: Behavioral: Nurse Alone; Behavioral: Dashboard Plus Nurse |
| Nurse Alone | Experimental | Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling. Receives: Behavioral: Nurse Alone |
| Control | No intervention | Patients randomized to this group were followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They had no contact with study personnel and did not receive any type of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk
Only the intervention patients were analyzed for this outcome.
Measured: From baseline to six-months
Secondary outcomes (1)
Change in Systolic Blood Pressure
Measured: From baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mahesh Merchant, PhD MSc, Principal investigator, Richard Roudebush VA Medical Center, Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133171
- Sponsor's protocol ID
- RRP 09-186
- Status last verified
- Oct 2015
- First submitted
- 26 May 2010
- Last updated
- 30 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Dashboard to Educate Veterans at Risk of Stroke
- ClinicalTrials.gov ID
- NCT01133171
- Acronym / sponsor ID
- RRP 09-186
- Conditions
- Cardiovascular Disease, Stroke
- Keywords
- Cardiovascular Disease, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 30 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Personalized risk communication methods have been used to educate patients that are at a high risk of developing cardiovascular disease. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to self-manage their risk factors and observe the changes in risk by making lifestyle changes and modifying other risk factors by seeking medical advice.
This Rapid Response Project (RRP) builds upon these methods of communication by presenting the modifiable risk factors in the form of a personalized dashboard that highlights the contribution of these risk factors on the risk of developing a cardiovascular event. The modifiable risk factors that will be addressed in this study will include medical and lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation, diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.
Our primary goal is to develop a prototype of the dashboard to educate patients and help them make informed decisions in modifying their risk factors to reduce the probability of a cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by asking these patients to return after 6 months to determine if they have made any lifestyle changes or pursued medical intervention to reduce their cardiovascular risk. We will make qualitative observations on the knowledge retention of these patients while using the interactive dashboard.
Detailed description
Background:
Personalized risk communication methods have been used to educate patients who are at high risk of developing a cardiovascular event. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to use to compare the relative change in risk that might result from modifying their risk factors.
Objectives:
The goals of this pilot study were to: (a) develop a prototype of a personalized dynamic dashboard to educate veterans and help them make informed decisions about modifying their vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and tobacco use) to reduce the probability of a vascular event; (b) test the usability of this tool from the patient's perspective; and (c) provide preliminary data regarding the effectiveness of this tool in terms of changes in lifestyle or risk factor control compared with nurse-education.
Methods:
This was a three-arm randomized controlled study. Veterans from the panel of one experienced general internist were randomly assigned to one of three groups: (1) dashboard with nurse-education, (2) nurse-education alone, (3) usual care. To be eligible, patients must have had at least two of the following: body mass index >30 kg/m2; current tobacco use; systolic blood pressure >140 mm Hg or diastolic >90 mm Hg; LDL-cholesterol >130 mg/dL, or hemoglobin Hb1Ac >8%. We developed the dashboard in our Human Computer Interface/Information Technology laboratory. Patients in the dashboard group received two in-person counseling sessions regarding methods for controlling risk factors, and were asked to use the dashboard tool to enter values for their own risk factors and to observe the relative effects of varying their risk factor control on their overall vascular risk. The nurse-education consisted of two in-person counseling sessions regarding methods for controlling risk factors. Both intervention sessions lasted approximately 30 minutes; therefore, the majority of the time was used to interact with the tool in the dashboard group whereas the entire time was used for personalized risk factor discussion in the nurse-education group. For the usual care group, data were retrospectively collected about the primary care visits and laboratory tests which took place during the same period as the visits for intervention patients.
Status:
Completed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dashboard Plus Nurse | Experimental | Behavioral: Nurse Alone, Behavioral: Dashboard Plus NursePatients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling plus a computerized dashboard intervention. |
| Nurse Alone | Experimental | Behavioral: Nurse AlonePatients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling. |
| Control | No intervention | –Patients randomized to this group were followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They had no contact with study personnel and did not receive any type of intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans receiving care from a Primary Care Clinic at the Roudebush VA Medical Center in Indianapolis with at least two of the following risk factors:
- Body Mass Index > 30
- Current Smoker
- Systolic Blood Pressure > 140 mm OR Diastolic Blood Pressure >90 mm
- Cholesterol LDL > 130 mg/dL
Key exclusion criteria (2 listed)
- Subjects on Dialysis
- Subjects on Supplemental Oxygen
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 |
|---|---|---|
| Nurse AlonePatients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors. | Behavioural | Dashboard Plus Nurse, Nurse Alone |
| Dashboard Plus NursePatients receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and were asked to use a computerized dashboard to enter values for the risk factors and observe the effects of the risk factors on the overall cardiovascular risk. | Behavioural | Dashboard Plus Nurse |
Primary outcome
Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk
Time frame: From baseline to six-months
Only the intervention patients were analyzed for this outcome.
1 secondary outcome
Change in Systolic Blood Pressure
Time frame: From baseline to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cardiovascular Disease
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
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.
Mahesh Merchant, PhD MSc principal investigator
Richard Roudebush VA Medical Center, Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Alone and Dashboard Plus Nurse in people with Cardiovascular Disease and Stroke, run by VA Office of Research and Development 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 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 30 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk (time frame: From baseline to six-months). 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 30 Oct 2015.