HypertensionNCT00682968
Evidence Synthesis: Hypertension Medication Adherence & Intensification
An observational study of Hypertension, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2008to 1 Oct 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VA clinicians, hospital administrators and PIs/authors of above studies
Who may be able to join
- Studies funded by VA from 1998 to the present looking at hypertension medication adherence and physician adherence to hypertension guidelines
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. While clinician failure to aggressively manage hypertension through therapeutic intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately) contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of patients fail to adhere to recommended therapies, indicating that adherence remains a central problem in hypertension care. This suggests important opportunities for interventions to improve risk factor control by working through clinicians, their teams, or their delivery systems, as well as with patients, to address both patient adherence and clinical inertia.
Read the detailed description
Background:
Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. While clinician failure to aggressively manage hypertension through therapeutic intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately) contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of patients fail to adhere to recommended therapies, indicating that adherence remains a central problem in hypertension care. This suggests important opportunities for interventions to improve risk factor control by working through clinicians, their teams, or their delivery systems, as well as with patients, to address both patient adherence and clinical inertia.
Objectives:
Recognizing the importance of understanding and intervening to improve adherence to antihypertensive medications and to address clinical inertia, VA HSR\&D has funded numerous studies in the last decade to address these issues, either through interventions or through exploratory studies to better understand the problems. There has been little discussion among investigators and clinical managers as to the comparative effectiveness of such approaches -- which practices are 'best' for use in VA, based on the evidence emerging from these studies. Thus, we conducted an evidence synthesis project to accomplish these aims, in order to summarize the literature and facilitate exchange among investigators and clinicians on the implications of this growing body of VA research.
Methods:
We sought to catalog and extensively describe all VA funded studies conducted over the past decade focusing on adherence to antihypertensive medications, therapeutic intensification, or both. We also included non-VA funded studies focused on the care of veterans receiving health care in VA. We aimed to describe gaps in current research and identify important areas for future research, synthesize results from the studies, whether published or unpublished, in the form of an evidence synthesis, and to build on these efforts to develop more formal exchange and collaboration among VA researchers and clinicians working on addressing these important issues.
Status:
Complete.
- Conditions
- Hypertension
- Keywords
- patient non-adherence, antihypertensive agents, hypertension
- Medical subject headings
- Hypertension, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence, physician guideline adherence
Measured: varies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study start20 Jul 2008
- Primary completion30 Sep 2008
- Study completion1 Oct 2008
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 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nancy R. Kressin, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682968
- Sponsor's protocol ID
- SHP 08-187
- Status last verified
- Jun 2017
- First submitted
- 20 May 2008
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Synthesis: Hypertension Medication Adherence & Intensification
- ClinicalTrials.gov ID
- NCT00682968
- Acronym / sponsor ID
- SHP 08-187
- Conditions
- Hypertension
- Keywords
- patient non-adherence, antihypertensive agents, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 Jul 2008 (actual)
- Primary completion
- 30 Sep 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 23 May 2008 (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.
Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. While clinician failure to aggressively manage hypertension through therapeutic intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately) contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of patients fail to adhere to recommended therapies, indicating that adherence remains a central problem in hypertension care. This suggests important opportunities for interventions to improve risk factor control by working through clinicians, their teams, or their delivery systems, as well as with patients, to address both patient adherence and clinical inertia.
Detailed description
Background:
Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. While clinician failure to aggressively manage hypertension through therapeutic intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately) contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of patients fail to adhere to recommended therapies, indicating that adherence remains a central problem in hypertension care. This suggests important opportunities for interventions to improve risk factor control by working through clinicians, their teams, or their delivery systems, as well as with patients, to address both patient adherence and clinical inertia.
Objectives:
Recognizing the importance of understanding and intervening to improve adherence to antihypertensive medications and to address clinical inertia, VA HSR\&D has funded numerous studies in the last decade to address these issues, either through interventions or through exploratory studies to better understand the problems. There has been little discussion among investigators and clinical managers as to the comparative effectiveness of such approaches -- which practices are 'best' for use in VA, based on the evidence emerging from these studies. Thus, we conducted an evidence synthesis project to accomplish these aims, in order to summarize the literature and facilitate exchange among investigators and clinicians on the implications of this growing body of VA research.
Methods:
We sought to catalog and extensively describe all VA funded studies conducted over the past decade focusing on adherence to antihypertensive medications, therapeutic intensification, or both. We also included non-VA funded studies focused on the care of veterans receiving health care in VA. We aimed to describe gaps in current research and identify important areas for future research, synthesize results from the studies, whether published or unpublished, in the form of an evidence synthesis, and to build on these efforts to develop more formal exchange and collaboration among VA researchers and clinicians working on addressing these important issues.
Status:
Complete.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VA clinicians, hospital administrators and PIs/authors of above studies
Key inclusion criteria (1 listed)
- Studies funded by VA from 1998 to the present looking at hypertension medication adherence and physician adherence to hypertension guidelines
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication adherence, physician guideline adherence
Time frame: varies
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 6 Jun 2017.
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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.
Nancy R. Kressin, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, 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 1 inclusion and 1 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 6 Jun 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.
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?
Medication adherence, physician guideline adherence (time frame: varies). 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 6 Jun 2017.