HypertensionNCT00760552
Trial of Low and High Intensity Strategies to Maintain BP Control
A study testing High Intensity Intervention, Low Intensity Intervention and All- 6 month pharmacist intervention in people with Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- High Intensity Intervention, Low Intensity Intervention and All- 6 month pharmacist intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Hypertension (HTN) captured by ICD-9-CM codes from prior outpatient visits;
- elevated BP (>140/90 mmHg among non-diabetics; or >140/80 mmHg among diabetics) during the most recent VA clinic visit or based on the average from the last 3 visits;
- elevated BP measured by the Research Medical Assistant (MA) at the baseline visit.
Who cannot join
- Patients will be excluded for the following safety reasons:
- prior history or current signs of hypertensive emergency including symptoms of angina, stroke, or acute renal failure;
- severe HTN (systolic BP >200 or diastolic BP > 114mm Hg);
- history of acute MI, stroke, or unstable angina in the prior 6 months;
- Congestive Heart Failure (CHF) due to systolic dysfunction with a left ventricular ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min or previously documented proteinuria > 1 gram per day;
Show all 13Show fewer
- significant hepatic disease, including prior diagnoses of cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 2 times control or total bilirubin > 1.5 mg/dl) in the prior 6 months;
- pregnancy;
- prior diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
- poor prognosis with a life expectancy estimated less than 2 years;
- residence in a nursing home or diagnosis of dementia;
- inability to give informed consent or impaired cognitive function (defined as > 3 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire, administered during study intake);
- no telephone for follow-up calls.
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
About this study
Official title: Trial of Low And High Intensity Strategies to Maintain Blood Pressure Control
The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health (NIH) studies of pharmacist-based HTN management. The long-term effectiveness of such models, especially in veterans, is unknown. Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in veterans with HTN following a 6-month intensive pharmacist intervention.
This study will enroll veterans with uncontrolled HTN into a 6-month intensive pharmacist-based intervention. Following this initial intervention, participants will be randomized to continued intervention or a one-time patient and provider education intervention. BP will be compared in the two groups over a 2-year follow-up period. The intervention to control and sustain BP will follow VA guidelines and include: 1) comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist visits to sustain BP control. The intervention is based on models identified in a recent Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies to improve BP. The study will benefit from a strong research team with expertise in guideline development, implementation science, quality measurement, and behavioral science. The study will also provide important information on the degree to which BP control deteriorates after patients are referred back to usual care. The specific aims and related hypotheses of the study are to:
Read more
Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist intervention or to a less intense one-time patient and provider education intervention.
Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher rates of BP control 24 months after randomization.
Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower mean BP 24 months after randomization.
Aim 2: Compare antihypertensive medication intensification in patients randomized to the continued pharmacist intervention or the less intense intervention.
Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will have medication intensification over the 24-month follow-up.
Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication adherence will be higher in patients randomized to the continued pharmacist intervention group during the 24 month follow-up period.
Hypothesis 3b: Improvements in medication adherence will be associated with improvements in BP during each study interval.
Read the detailed description
We are proposing a 4-year trial to determine if long-term blood pressure (BP) control after a pharmacist intervention requires continuation of the intervention or if a less intense strategy is equally efficacious. The intervention builds on the Chronic Care Model, recent Veteran Affairs (VA) trials, and our pharmacist interventions. This research has convincingly shown that collaborative interventions can improve BP control over 6-9 months. However, no randomized study has evaluated strategies to sustain the effect of such interventions.
The study will enroll 300 patients with uncontrolled HTN at the Iowa City Veteran Affairs Medical Center (VAMC) and an affiliated community based outpatient clinic (CBOC). All patients will receive a pharmacist intervention for 6 months that will follow VA HTN guidelines. Patients completing the intervention will then be randomized to continuation of the high intensity intervention or to a one-time patient and provider education intervention that was recently shown to be effective. The high intensity (HI) intervention will intensify medication regimens when BP deteriorates, sustain adherence, and improve monitoring to reduce adverse drug reactions. The low intensity (LI) intervention will involve usual care by patients primary care provider (PCPs) and a one-time education intervention including a letter emphasizing the importance of medication adherence and behavioral strategies to improve BP control (e.g., low-salt diets, exercise). PCPs of low intensity patients will also receive a computerized alert with treatment recommendations and links to BP guidelines.
The primary endpoint-BP-will be assessed using standard measurements at 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization). The 24-month evaluation phase will determine if BP control can be sustained or improved with a continued high intensity intervention, relative to a low intensity intervention (Aim 1). All medication changes will be assessed to compare rates of medication intensification over the follow-up period (Aim 2). Finally, validated self-report adherence questionnaires will be used to compare medication adherence in the two groups and determine relationships between BP control and medication adherence (Aim 3).
- Conditions
- Hypertension
- Being tested
- High Intensity Intervention, Low Intensity Intervention, All- 6 month pharmacist intervention
- Keywords
- Hypertension, Adherence, Pharmacist, Interdisciplinary, Randomized Controlled, Primary Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity InterventionOther
High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
Low Intensity InterventionOther
Low intensity group will receive management by their PCP and a 3-part intervention that was effective in a recent VA study. This one-time intervention will occur 3 months after completion of the initial 6-month pharmacist intervention and will include: Provider education including an email message to re-evaluate the specific patient's BP regimen and a web link to the VA/JNC-7 hypertension guidelines. 1-time patient-specific computerized alert reminding the PCP of the goal BP, values of the patient's last 3 BP assessments, \& possible options for medication changes if BP does not remain at goal. Patient education including a personalized letter with information on strategies to improve BP control, including medication adherence, Dietary Approaches to Stop Hypertension (DASH) diet/exercise. The letter will note that many patients require more than one medication and will provide a link to the VA patient education web library and American Heart Association (AHA) site.
All- 6 month pharmacist interventionOther
All patients will receive the initial 6-month pharmacist intervention. The intervention: 1) co-management of HTN by pharmacists can improve BP control; and 2) active follow-up is needed to reinforce progress and proactively identify and resolve problems. The intervention will include structured visits at baseline 1, 2, 4, and 6 months after baseline and telephone calls at 2 weeks and between the visits. At baseline, the pharmacist will review the computerized patient record system (CPRS) medical record and perform a structured interview, including: a detailed medication history of all prescription and non-prescription therapies; an assessment of patient knowledge of all meds, the purpose of each med, medication dosages and timing, and potential side effects; potential contraindications to specific medications; and expectations for future dosage changes and of the need for future monitoring potential barriers to BP control.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | VA patients with uncontrolled HTN. Receives: Other: High Intensity Intervention; Other: All- 6 month pharmacist intervention |
| Arm 2 | Active comparator | VA patients with uncontrolled HTN. Receives: Other: Low Intensity Intervention; Other: All- 6 month pharmacist intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Change
Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint-BP-will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).
Measured: Measured at Baseline, and 6,12,18,24, and 30 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 posted26 Sep 2008 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gary E. Rosenthal, MD, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760552
- Sponsor's protocol ID
- IIR 07-145
- Status last verified
- Nov 2014
- First submitted
- 24 Sep 2008
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carter BL, Coffey CS, Uribe L, James PA, Egan BM, Ardery G, Chrischilles EA, Ecklund D, Vander Weg M, Vaughn T; Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial investigators. Similar blood pressure values across racial and economic groups: baseline data from a group randomized clinical trial. J Clin Hypertens (Greenwich). 2013 Jun;15(6):404-12. doi: 10.1111/jch.12091. Epub 2013 Apr 1.
PubMed 23730989Parker CP, Cunningham CL, Carter BL, Vander Weg MW, Richardson KK, Rosenthal GE. A mixed-method approach to evaluate a pharmacist intervention for veterans with hypertension. J Clin Hypertens (Greenwich). 2014 Feb;16(2):133-40. doi: 10.1111/jch.12250.
PubMed 24588813Carter BL, Chrischilles EA, Rosenthal G, Gryzlak BM, Eisenstein EL, Vander Weg MW. Efficacy and safety of nighttime dosing of antihypertensives: review of the literature and design of a pragmatic clinical trial. J Clin Hypertens (Greenwich). 2014 Feb;16(2):115-21. doi: 10.1111/jch.12238. Epub 2013 Dec 24.
PubMed 24373519Hawkins MS, Hough LJ, Berger MA, Mor MK, Steenkiste AR, Gao S, Stone RA, Burkitt KH, Marcus BH, Ciccolo JT, Kriska AM, Klinvex DT, Sevick MA. Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study. Trials. 2014 Jan 7;15:11. doi: 10.1186/1745-6215-15-11.
PubMed 24398076Carter BL, Vander Weg MW, Parker CP, Goedken CC, Richardson KK, Rosenthal GE. Sustained Blood Pressure Control Following Discontinuation of a Pharmacist Intervention for Veterans. J Clin Hypertens (Greenwich). 2015 Sep;17(9):701-8. doi: 10.1111/jch.12577. Epub 2015 Jun 1.
PubMed 26032843
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Low And High Intensity Strategies to Maintain Blood Pressure Control
- ClinicalTrials.gov ID
- NCT00760552
- Acronym / sponsor ID
- IIR 07-145
- Conditions
- Hypertension
- Keywords
- Hypertension, Adherence, Pharmacist, Interdisciplinary, Randomized Controlled, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 17 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health (NIH) studies of pharmacist-based HTN management. The long-term effectiveness of such models, especially in veterans, is unknown. Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in veterans with HTN following a 6-month intensive pharmacist intervention.
This study will enroll veterans with uncontrolled HTN into a 6-month intensive pharmacist-based intervention. Following this initial intervention, participants will be randomized to continued intervention or a one-time patient and provider education intervention. BP will be compared in the two groups over a 2-year follow-up period. The intervention to control and sustain BP will follow VA guidelines and include: 1) comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist visits to sustain BP control. The intervention is based on models identified in a recent Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies to improve BP. The study will benefit from a strong research team with expertise in guideline development, implementation science, quality measurement, and behavioral science. The study will also provide important information on the degree to which BP control deteriorates after patients are referred back to usual care. The specific aims and related hypotheses of the study are to:
Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist intervention or to a less intense one-time patient and provider education intervention.
Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher rates of BP control 24 months after randomization.
Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower mean BP 24 months after randomization.
Aim 2: Compare antihypertensive medication intensification in patients randomized to the continued pharmacist intervention or the less intense intervention.
Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will have medication intensification over the 24-month follow-up.
Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication adherence will be higher in patients randomized to the continued pharmacist intervention group during the 24 month follow-up period.
Hypothesis 3b: Improvements in medication adherence will be associated with improvements in BP during each study interval.
Detailed description
We are proposing a 4-year trial to determine if long-term blood pressure (BP) control after a pharmacist intervention requires continuation of the intervention or if a less intense strategy is equally efficacious. The intervention builds on the Chronic Care Model, recent Veteran Affairs (VA) trials, and our pharmacist interventions. This research has convincingly shown that collaborative interventions can improve BP control over 6-9 months. However, no randomized study has evaluated strategies to sustain the effect of such interventions.
The study will enroll 300 patients with uncontrolled HTN at the Iowa City Veteran Affairs Medical Center (VAMC) and an affiliated community based outpatient clinic (CBOC). All patients will receive a pharmacist intervention for 6 months that will follow VA HTN guidelines. Patients completing the intervention will then be randomized to continuation of the high intensity intervention or to a one-time patient and provider education intervention that was recently shown to be effective. The high intensity (HI) intervention will intensify medication regimens when BP deteriorates, sustain adherence, and improve monitoring to reduce adverse drug reactions. The low intensity (LI) intervention will involve usual care by patients primary care provider (PCPs) and a one-time education intervention including a letter emphasizing the importance of medication adherence and behavioral strategies to improve BP control (e.g., low-salt diets, exercise). PCPs of low intensity patients will also receive a computerized alert with treatment recommendations and links to BP guidelines.
The primary endpoint-BP-will be assessed using standard measurements at 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization). The 24-month evaluation phase will determine if BP control can be sustained or improved with a continued high intensity intervention, relative to a low intensity intervention (Aim 1). All medication changes will be assessed to compare rates of medication intensification over the follow-up period (Aim 2). Finally, validated self-report adherence questionnaires will be used to compare medication adherence in the two groups and determine relationships between BP control and medication adherence (Aim 3).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: High Intensity Intervention, Other: All- 6 month pharmacist interventionVA patients with uncontrolled HTN. |
| Arm 2 | Active comparator | Other: Low Intensity Intervention, Other: All- 6 month pharmacist interventionVA patients with uncontrolled HTN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Hypertension (HTN) captured by ICD-9-CM codes from prior outpatient visits;
- elevated BP (>140/90 mmHg among non-diabetics; or >140/80 mmHg among diabetics) during the most recent VA clinic visit or based on the average from the last 3 visits;
- elevated BP measured by the Research Medical Assistant (MA) at the baseline visit.
Key exclusion criteria (13 listed)
- prior history or current signs of hypertensive emergency including symptoms of angina, stroke, or acute renal failure;
- severe HTN (systolic BP >200 or diastolic BP > 114mm Hg);
- history of acute MI, stroke, or unstable angina in the prior 6 months;
- Congestive Heart Failure (CHF) due to systolic dysfunction with a left ventricular ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min or previously documented proteinuria > 1 gram per day;
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 |
|---|---|---|
| High Intensity InterventionHigh Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP. | Other | Arm 1 |
| Low Intensity InterventionLow intensity group will receive management by their PCP and a 3-part intervention that was effective in a recent VA study. This one-time intervention will occur 3 months after completion of the initial 6-month pharmacist intervention and will include: Provider education including an email message to re-evaluate the specific patient's BP regimen and a web link to the VA/JNC-7 hypertension guidelines. 1-time patient-specific computerized alert reminding the PCP of the goal BP, values of the patient's last 3 BP assessments, \& possible options for medication changes if BP does not remain at goal. Patient education including a personalized letter with information on strategies to improve BP control, including medication adherence, Dietary Approaches to Stop Hypertension (DASH) diet/exercise. The letter will note that many patients require more than one medication and will provide a link to the VA patient education web library and American Heart Association (AHA) site. | Other | Arm 2 |
| All- 6 month pharmacist interventionAll patients will receive the initial 6-month pharmacist intervention. The intervention: 1) co-management of HTN by pharmacists can improve BP control; and 2) active follow-up is needed to reinforce progress and proactively identify and resolve problems. The intervention will include structured visits at baseline 1, 2, 4, and 6 months after baseline and telephone calls at 2 weeks and between the visits. At baseline, the pharmacist will review the computerized patient record system (CPRS) medical record and perform a structured interview, including: a detailed medication history of all prescription and non-prescription therapies; an assessment of patient knowledge of all meds, the purpose of each med, medication dosages and timing, and potential side effects; potential contraindications to specific medications; and expectations for future dosage changes and of the need for future monitoring potential barriers to BP control. | Other | Arm 1, Arm 2 |
Primary outcome
Blood Pressure Change
Time frame: Measured at Baseline, and 6,12,18,24, and 30 months post baseline.
Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint-BP-will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23730989Carter BL, Coffey CS, Uribe L, James PA, Egan BM, Ardery G, Chrischilles EA, Ecklund D, Vander Weg M, Vaughn T; Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial investigators. Similar blood pressure values across racial and economic groups: baseline data from a group randomized clinical trial. J Clin Hypertens (Greenwich). 2013 Jun;15(6):404-12. doi: 10.1111/jch.12091. Epub 2013 Apr 1.
- Results publication: PubMed 24588813Parker CP, Cunningham CL, Carter BL, Vander Weg MW, Richardson KK, Rosenthal GE. A mixed-method approach to evaluate a pharmacist intervention for veterans with hypertension. J Clin Hypertens (Greenwich). 2014 Feb;16(2):133-40. doi: 10.1111/jch.12250.
- Results publication: PubMed 24373519Carter BL, Chrischilles EA, Rosenthal G, Gryzlak BM, Eisenstein EL, Vander Weg MW. Efficacy and safety of nighttime dosing of antihypertensives: review of the literature and design of a pragmatic clinical trial. J Clin Hypertens (Greenwich). 2014 Feb;16(2):115-21. doi: 10.1111/jch.12238. Epub 2013 Dec 24.
- Results publication: PubMed 24398076Hawkins MS, Hough LJ, Berger MA, Mor MK, Steenkiste AR, Gao S, Stone RA, Burkitt KH, Marcus BH, Ciccolo JT, Kriska AM, Klinvex DT, Sevick MA. Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study. Trials. 2014 Jan 7;15:11. doi: 10.1186/1745-6215-15-11.
- Derived from this study: PubMed 26032843Carter BL, Vander Weg MW, Parker CP, Goedken CC, Richardson KK, Rosenthal GE. Sustained Blood Pressure Control Following Discontinuation of a Pharmacist Intervention for Veterans. J Clin Hypertens (Greenwich). 2015 Sep;17(9):701-8. doi: 10.1111/jch.12577. Epub 2015 Jun 1.
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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.
Gary E. Rosenthal, MD principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Intervention, Low Intensity Intervention and All- 6 month pharmacist intervention in people with Hypertension, run by US Department of Veterans Affairs 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 13 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 27 Apr 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 17 Dec 2014). 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?
Blood Pressure Change (time frame: Measured at Baseline, and 6,12,18,24, and 30 months post baseline.). 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 NCT00760552, which also lists 5 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 27 Apr 2015.