HypertensionPhase 4NCT00133068
Collaboration to Reduce Disparities in Hypertension
A Phase 4 study testing Computer, Reduction in financial barrier and Computer intervention & reduction of financial barrier in people with Hypertension, run by University of Pennsylvania at 3 sites in United States.
Trial summary
A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Computer, Reduction in financial barrier and Computer intervention & reduction of financial barrier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2005to Aug 2008
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.
Who cannot join
- Under 21 years of age
- Have a diagnosis of:
- Atrial fibrillation;
- Metastatic cancer;
- End stage renal disease (ESRD) with dialysis;
- Dementia;
Show all 10Show fewer
- New York Heart Association (NYHA) class IV congestive heart failure (CHF);
- Blind or deaf;
- Other reason for life expectancy of less than 1 year.
- Are currently participating in another experimental study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PinnacleHealth Adult Outpatient Clinics
Harrisburg, Pennsylvania, 17101
Veterans Administration Medical Center
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.
Read the detailed description
The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.
The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:
- test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount. H1: Reimbursing patients for filling prescriptions will significantly improve BP control.
- test whether a computer-based behavioral intervention improves BP control by a clinically significant amount. H2: A computer-based behavioral intervention will significantly improve BP control.
- test whether the two interventions are more effective in improving BP control than either alone. H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.
- examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.
H4: Both interventions will be cost-effective relative to other commonly-covered services.
- Conditions
- Hypertension
- Being tested
- Computer, Reduction in financial barrier, Computer intervention & reduction of financial barrier, Control
- Keywords
- High Blood Pressure, Health Behaviors, Patient Compliance
- Medical subject headings
- Hypertension, Health Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComputerBehavioural
Computer intervention only
Reduction in financial barrierBehavioural
Copay only
Computer intervention & reduction of financial barrierBehavioural
computer intervention \& copay
ControlBehavioural
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Control Receives: Behavioral: Control |
| 2 | Experimental | Reduction of financial barrier Receives: Behavioral: Reduction in financial barrier |
| 3 | Experimental | Computer Intervention Receives: Behavioral: Computer |
| 4 | Experimental | Reduction of financial barrier and Computer Intervention Receives: Behavioral: Computer intervention & reduction of financial barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 6 months
Secondary outcomes (2)
Cost
Measured: 12 months
Blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, Dickinson College, Pfizer
- Responsible party
- Principal investigator, Stephen E. Kimmel, University of Pennsylvania
- Investigators
- Stephen E. Kimmel, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133068
- Sponsor's protocol ID
- 707850
- Status last verified
- May 2016
- First submitted
- 19 Aug 2005
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Volpp KG, Troxel AB, Long JA, Ibrahim SA, Appleby D, Smith JO, Jaskowiak J, Helweg-Larsen M, Doshi JA, Kimmel SE. A randomized controlled trial of co-payment elimination: the CHORD trial. Am J Manag Care. 2015 Aug;21(8):e455-64.
PubMed 26625505
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration to Reduce Disparities in Hypertension
- ClinicalTrials.gov ID
- NCT00133068
- Acronym / sponsor ID
- 707850
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Health Behaviors, Patient Compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, Dickinson College, Pfizer
- Study start
- Mar 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Aug 2005 (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.
A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.
Detailed description
The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.
The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:
- test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount. H1: Reimbursing patients for filling prescriptions will significantly improve BP control.
- test whether a computer-based behavioral intervention improves BP control by a clinically significant amount. H2: A computer-based behavioral intervention will significantly improve BP control.
- test whether the two interventions are more effective in improving BP control than either alone. H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.
- examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.
H4: Both interventions will be cost-effective relative to other commonly-covered services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: ControlControl |
| 2 | Experimental | Behavioral: Reduction in financial barrierReduction of financial barrier |
| 3 | Experimental | Behavioral: ComputerComputer Intervention |
| 4 | Experimental | Behavioral: Computer intervention & reduction of financial barrierReduction of financial barrier and Computer Intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.
Key exclusion criteria (10 listed)
- Under 21 years of age
- Have a diagnosis of:
- Are currently participating in another experimental 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 |
|---|---|---|
| ComputerComputer intervention only | Behavioural | 3 |
| Reduction in financial barrierCopay only | Behavioural | 2 |
| Computer intervention & reduction of financial barriercomputer intervention \& copay | Behavioural | 4 |
| ControlNo intervention | Behavioural | 1 |
Primary outcome
Blood pressure
Time frame: 6 months
2 secondary outcomes
Cost
Time frame: 12 months
Blood pressure
Time frame: 12 months
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 12 May 2016.
- Derived from this study: PubMed 26625505Volpp KG, Troxel AB, Long JA, Ibrahim SA, Appleby D, Smith JO, Jaskowiak J, Helweg-Larsen M, Doshi JA, Kimmel SE. A randomized controlled trial of co-payment elimination: the CHORD trial. Am J Manag Care. 2015 Aug;21(8):e455-64.
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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.
Stephen E. Kimmel, MD, MSCE principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Computer, Reduction in financial barrier and Computer intervention & reduction of financial barrier in people with Hypertension, run by University of Pennsylvania at 3 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 1 inclusion and 10 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133068, which also lists 1 linked publication.
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 12 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.