CVDPhase 3e-CompareNCT01077388
e-Care for Heart Wellness
A Phase 3 study testing Dietician electronic support in people with CVD, run by Kaiser Permanente at 1 site in United States.
Trial summary
The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting heart disease. We are asking about 100 Group Health members whose electronic medical record shows they have uncontrolled high blood pressure to be in the study. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- CVD
- What is being tested?
- Dietician electronic support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2012
- Phase
- Phase 3
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults age 30-<70 men and women who have received care at GH primary care medical centers in Western Washington and who have been continuously enrolled in GH for at least 2 years.
- BMI 26 or higher,
- Uncontrolled HTN (based on the 2 most recent visits), and moderate risk for CVD.
Who cannot join
- A history of any type of cardiovascular disease (CVD). Including TIA, stroke, coronary heart disease (CHD), angina, congestive heart failure (CHF), peripheral arterial disease (PAD), ar, CHF, PAD), arrhythmias, cardiomyopathy, and valvular disease.
- Pre existing diagnosis of diabetes
- Diagnosis of a serious life threatening or limiting condition
- Pre existing diagnosis of alcohol or chemical dependency
- Pregnant or planning on becoming pregnant in the next 6 months. Women randomized to the intervention group who become pregnant during the study will be given the option of continuing the intervention in conjunction with usual pre-natal care provided by GH, but will not be included in the final analysis for the study. Women randomized to the self care group who become pregnant during the study will be given the home monitoring equipment usually given to the control group at the end of the study. They will then be referred for usual care and will also not be included in the final analysis for the study.
- Unable or unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)
The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting heart disease. We are asking about 100 Group Health members whose electronic medical record shows they have uncontrolled high blood pressure to be in the study. Having high blood pressure increases your future risk of heart attacks and strokes.
There are many things you can do to help keep your heart healthy. Examples include lowering blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test whether getting care and supportive emails from a dietician helps people do things like this to lower their chances of having a heart attack or a stroke.
For some people, this study will involve both research and clinical care. About half the people in the study will receive care related to heart disease prevention from a dietician. It's a standard clinical practice for dieticians to help people reduce their risk of heart attacks and strokes. What's different about this study is using emails from a dietician to help people take steps to improve their heart health.
Read the detailed description
Overweight and obese adults are more likely to have hypertension and other risk factors for cardiovascular disease (CVD). Evidence-based medication and lifestyle strategies exist for reducing CVD risk, but little is known about the comparative effectiveness and cost-effectiveness of these strategies and how best to integrate them into routine health care. We have previously demonstrated that Web-based pharmacist medication management intervention can cost-effectively improve HTN control (e-BP: Electronic Communication and Home Blood Pressure Monitoring; R01 HL075263, B. Green, PI). Web-based pharmacy care did not lead to lifestyle behavior change or weight loss. However patients who lost small amounts of weight (2 kg or more) were more likely to have controlled BP (p=.008), regardless of their study group assignment. We propose using Health Information Technology systems (HIT) to identify asymptomatic patients at moderate risk for CVD and invite them to participate in a theory-based behavioral intervention that uses the Chronic Care Model as its planning foundation.
Specific Aims Aim #1: We hypothesize that using electronic databases alone, we can identify asymptomatic overweight or obese patients, with uncontrolled BP, and at moderate risk for CVD who might benefit from a behavioral intervention.
Aim #2: We hypothesize that a dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, can be integrated into routine healthcare and will result in improved control of modifiable CVD risk. To test this hypothesis we will measure:
Primary outcomes:
- The proportion of patients who agree to participate and complete the intervention.
- The change in mean systolic and diastolic BP and weight (kg), and a weight loss of 4 kg or more, and the change in Framingham risk score.
Secondary outcomes:
- Patient satisfaction with the intervention, its effects on health related quality of life (HrQOL) and the cost of delivering the intervention.
Using this information and the results of the e-BP trial we will plan a full scale, multi-site (2-3 health institutions with comprehensive EMR's and different geographic and patient populations) multi-factorial randomized trial-to test the comparative effectiveness of different strategies to improve control of modifiable CVD risk.
- Conditions
- CVD
- Being tested
- Dietician electronic support
- Keywords
- CVD, uncontrolled HTN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietician electronic supportBehavioural
Dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, will be integrated into routine healthcare and will result in improved control of modifiable CVD risk.
| Study group | Role | What they receive |
|---|---|---|
| Dietician electronic counseling | Experimental | This arm will receive care and supportive emails and phone calls from a study dietician for about 6 months. We will also provide a blood pressure monitor, a pedometer, and a scale with instructions for using them at home. Receives: Behavioral: Dietician electronic support |
| Self Care | No intervention | This arm will continue to get care as usual from their regular doctor. They will also get a blood pressure monitor and a scale at the end of the study. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CVDStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Beverly Green, MD,MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077388
- Sponsor's protocol ID
- 2R01HL075263-05
- Acronym
- e-Compare
- Status last verified
- Oct 2017
- First submitted
- 25 Feb 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid RJ. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. Am J Prev Med. 2014 Apr;46(4):368-77. doi: 10.1016/j.amepre.2013.11.009.
PubMed 24650839Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid R. Using body mass index data in the electronic health record to calculate cardiovascular risk. Am J Prev Med. 2012 Apr;42(4):342-7. doi: 10.1016/j.amepre.2011.12.009.
PubMed 22424246
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)
- ClinicalTrials.gov ID
- NCT01077388
- Acronym / sponsor ID
- e-Compare / 2R01HL075263-05
- Conditions
- CVD
- Keywords
- CVD, uncontrolled HTN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Mar 2010 (estimated)
- 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 e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting heart disease. We are asking about 100 Group Health members whose electronic medical record shows they have uncontrolled high blood pressure to be in the study. Having high blood pressure increases your future risk of heart attacks and strokes.
There are many things you can do to help keep your heart healthy. Examples include lowering blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test whether getting care and supportive emails from a dietician helps people do things like this to lower their chances of having a heart attack or a stroke.
For some people, this study will involve both research and clinical care. About half the people in the study will receive care related to heart disease prevention from a dietician. It's a standard clinical practice for dieticians to help people reduce their risk of heart attacks and strokes. What's different about this study is using emails from a dietician to help people take steps to improve their heart health.
Detailed description
Overweight and obese adults are more likely to have hypertension and other risk factors for cardiovascular disease (CVD). Evidence-based medication and lifestyle strategies exist for reducing CVD risk, but little is known about the comparative effectiveness and cost-effectiveness of these strategies and how best to integrate them into routine health care. We have previously demonstrated that Web-based pharmacist medication management intervention can cost-effectively improve HTN control (e-BP: Electronic Communication and Home Blood Pressure Monitoring; R01 HL075263, B. Green, PI). Web-based pharmacy care did not lead to lifestyle behavior change or weight loss. However patients who lost small amounts of weight (2 kg or more) were more likely to have controlled BP (p=.008), regardless of their study group assignment. We propose using Health Information Technology systems (HIT) to identify asymptomatic patients at moderate risk for CVD and invite them to participate in a theory-based behavioral intervention that uses the Chronic Care Model as its planning foundation.
Specific Aims Aim #1: We hypothesize that using electronic databases alone, we can identify asymptomatic overweight or obese patients, with uncontrolled BP, and at moderate risk for CVD who might benefit from a behavioral intervention.
Aim #2: We hypothesize that a dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, can be integrated into routine healthcare and will result in improved control of modifiable CVD risk. To test this hypothesis we will measure:
Primary outcomes:
- The proportion of patients who agree to participate and complete the intervention.
- The change in mean systolic and diastolic BP and weight (kg), and a weight loss of 4 kg or more, and the change in Framingham risk score.
Secondary outcomes:
- Patient satisfaction with the intervention, its effects on health related quality of life (HrQOL) and the cost of delivering the intervention.
Using this information and the results of the e-BP trial we will plan a full scale, multi-site (2-3 health institutions with comprehensive EMR's and different geographic and patient populations) multi-factorial randomized trial-to test the comparative effectiveness of different strategies to improve control of modifiable CVD risk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietician electronic counseling | Experimental | Behavioral: Dietician electronic supportThis arm will receive care and supportive emails and phone calls from a study dietician for about 6 months. We will also provide a blood pressure monitor, a pedometer, and a scale with instructions for using them at home. |
| Self Care | No intervention | –This arm will continue to get care as usual from their regular doctor. They will also get a blood pressure monitor and a scale at the end of the study. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adults age 30-<70 men and women who have received care at GH primary care medical centers in Western Washington and who have been continuously enrolled in GH for at least 2 years.
- BMI 26 or higher,
- Uncontrolled HTN (based on the 2 most recent visits), and moderate risk for CVD.
Key exclusion criteria (6 listed)
- A history of any type of cardiovascular disease (CVD). Including TIA, stroke, coronary heart disease (CHD), angina, congestive heart failure (CHF), peripheral arterial disease (PAD), ar, CHF, PAD), arrhythmias, cardiomyopathy, and valvular disease.
- Pre existing diagnosis of diabetes
- Diagnosis of a serious life threatening or limiting condition
- Pre existing diagnosis of alcohol or chemical dependency
- Pregnant or planning on becoming pregnant in the next 6 months. Women randomized to the intervention group who become pregnant during the study will be given the option of continuing the intervention in conjunction with usual pre-natal care provided by GH, but will not be included in the final analysis for the study. Women randomized to the self care group who become pregnant during the study will be given the home monitoring equipment usually given to the control group at the end of the study. They will then be referred for usual care and will also not be included in the final analysis for the study.
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 |
|---|---|---|
| Dietician electronic supportDietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, will be integrated into routine healthcare and will result in improved control of modifiable CVD risk. | Behavioural | Dietician electronic counseling |
Primary outcome
Not reported in the source record.
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 13 Oct 2017.
- Derived from this study: PubMed 24650839Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid RJ. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. Am J Prev Med. 2014 Apr;46(4):368-77. doi: 10.1016/j.amepre.2013.11.009.
- Derived from this study: PubMed 22424246Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid R. Using body mass index data in the electronic health record to calculate cardiovascular risk. Am J Prev Med. 2012 Apr;42(4):342-7. doi: 10.1016/j.amepre.2011.12.009.
Related trials for CVD
Recruiting
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
Moya Moya Disease, Moyamoya Syndrome
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
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.
Beverly Green, MD,MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dietician electronic support in people with CVD, run by Kaiser Permanente 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 3 inclusion and 6 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 13 Oct 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077388, which also lists 2 linked publications.
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 13 Oct 2017.