HypertensionNCT00105716
Study to Lower Veterans BP: Patient/Physician Intervention
A study testing Telephone behavioral education and Computer behavioral education in people with Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Telephone behavioral education and Computer behavioral education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Apr 2005
- Phase
- Interventional
- 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
Who may be able to join
- >1 ICD9 Diagnosis 401.0, 401.1, 401.9
- Designated Primary Care Provider
- >1 Primary Care visit between 1/01/01-12/31/01
- Restricted to NC and VA addresses
- >1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805
Who cannot join
- Dialysis patient
- Hospitalization for stroke in prior 3 months
- Myocardial infarction in prior 3 months
- Coronary artery revascularization in prior 3 months
- Metastatic cancer diagnosis in prior 3 months
- Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
Show all 9Show fewer
- Nursing home resident
- Documented diagnosis of dementia
- Difficulty hearing
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention
This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Read the detailed description
Background:
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension, yet only 31% have their blood pressure (BP) under effective control. Uncontrolled hypertension greatly increases the risk of stroke, CAD, renal failure, CHF, and mortality.
Objectives:
This four year study evaluated simultaneously both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses were: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient behavioral/education intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Methods:
This was a randomized controlled trial with a split-plot design. Thirty primary care providers in the Durham VAMC Primary Care Clinic were randomly assigned to receive either the provider intervention or basic patient information; 588 of their hypertensive patients were randomized to the patient intervention or usual care. The provider intervention (ATHENA study (IIR 99-275) included an electronically generated hypertension decision support system (DSS) delivered to the provider at each hypertensive patient's visit. The provider intervention was designed to improve guideline concordant therapy. The patient intervention was a tailored behavioral/education intervention administered at periodic telephone contacts. The intervention included support and reminders, information on hypertension and on health behaviors. Patients received feedback about their recent BP values, continuous patient education, and were monitored and supported to enhance adherence. The control group was usual care.
Status:
Complete. Major activities completed in the past 12 months include submission of a manuscript describing the study, the interventions, and baseline and follow-up analyses. Secondary analyses are being completed which will be included in additional manuscripts.
- Conditions
- Hypertension
- Being tested
- Telephone behavioral education, Computer behavioral education
- Keywords
- hypertension, adherence, cardiovascular diseases
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone behavioral educationBehavioural
Computer behavioral educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Telephone behavioral education; Behavioral: Computer behavioral education |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
Secondary outcomes (1)
Knowledge and perceived risks associated with hypertension and ability to continue hypertension regimen will be assessed at baseline and via telephone 6 and 24 months after baseline; Medication adherence will be assessed from pharmacy records
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startMar 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hayden B. Bosworth, PhD, Principal investigator, Durham VA Medical Center, Durham, NCEugene Z. Oddone, MD MHSc, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105716
- Sponsor's protocol ID
- IIR 20-034
- Status last verified
- Apr 2006
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Datta SK, Oddone EZ, Olsen MK, Orr M, McCant F, Gentry P, Bosworth HB. Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients. Am Heart J. 2010 Aug;160(2):257-63. doi: 10.1016/j.ahj.2010.05.024.
PubMed 20691830Powers BJ, Olsen MK, Oddone EZ, Bosworth HB. The effect of a hypertension self-management intervention on diabetes and cholesterol control. Am J Med. 2009 Jul;122(7):639-46. doi: 10.1016/j.amjmed.2008.12.022.
PubMed 19559166Thorpe CT, Bryson CL, Maciejewski ML, Bosworth HB. Medication acquisition and self-reported adherence in veterans with hypertension. Med Care. 2009 Apr;47(4):474-81. doi: 10.1097/mlr.0b013e31818e7d4d.
PubMed 19330891Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
PubMed 19249414Powers BJ, Olsen MK, Oddone EZ, Thorpe CT, Bosworth HB. Literacy and blood pressure--do healthcare systems influence this relationship? A cross-sectional study. BMC Health Serv Res. 2008 Oct 23;8:219. doi: 10.1186/1472-6963-8-219.
PubMed 18947408Olsen MK, DeLong ER, Oddone EZ, Bosworth HB. Strategies for analyzing multilevel cluster-randomized studies with binary outcomes collected at varying intervals of time. Stat Med. 2008 Dec 20;27(29):6055-71. doi: 10.1002/sim.3446.
PubMed 18825655Walsh JM, Sundaram V, McDonald K, Owens DK, Goldstein MK. Implementing effective hypertension quality improvement strategies: barriers and potential solutions. J Clin Hypertens (Greenwich). 2008 Apr;10(4):311-6. doi: 10.1111/j.1751-7176.2008.07425.x.
PubMed 18401229Cho AH, Voils CI, Yancy WS Jr, Oddone EZ, Bosworth HB. Does participatory decision making improve hypertension self-care behaviors and outcomes? J Clin Hypertens (Greenwich). 2007 May;9(5):330-6. doi: 10.1111/j.1524-6175.2007.06489.x.
PubMed 17485968Powers BJ, Oddone EZ, Grubber JM, Olsen MK, Bosworth HB. Perceived and actual stroke risk among men with hypertension. J Clin Hypertens (Greenwich). 2008 Apr;10(4):287-94. doi: 10.1111/j.1751-7176.2008.07797.x.
PubMed 18401226Lin ND, Martins SB, Chan AS, Coleman RW, Bosworth HB, Oddone EZ, Shankar RD, Musen MA, Hoffman BB, Goldstein MK. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. AMIA Annu Symp Proc. 2006;2006:494-8.
PubMed 17238390Lowry KP, Dudley TK, Oddone EZ, Bosworth HB. Intentional and unintentional nonadherence to antihypertensive medication. Ann Pharmacother. 2005 Jul-Aug;39(7-8):1198-203. doi: 10.1345/aph.1E594. Epub 2005 Jun 14.
PubMed 15956238Bosworth HB, Olsen MK, Goldstein MK, Orr M, Dudley T, McCant F, Gentry P, Oddone EZ. The veterans' study to improve the control of hypertension (V-STITCH): design and methodology. Contemp Clin Trials. 2005 Apr;26(2):155-68. doi: 10.1016/j.cct.2004.12.006.
PubMed 15837438Bosworth HB, Oddone EZ. A model of psychosocial and cultural antecedents of blood pressure control. J Natl Med Assoc. 2002 Apr;94(4):236-48.
PubMed 11991336Chan AS, Coleman RW, Martins SB, Advani A, Musen MA, Bosworth HB, Oddone EZ, Shlipak MG, Hoffman BB, Goldstein MK. Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension. Stud Health Technol Inform. 2004;107(Pt 1):125-9.
PubMed 15360788Steinman MA, Fischer MA, Shlipak MG, Bosworth HB, Oddone EZ, Hoffman BB, Goldstein MK. Clinician awareness of adherence to hypertension guidelines. Am J Med. 2004 Nov 15;117(10):747-54. doi: 10.1016/j.amjmed.2004.03.035.
PubMed 15541324
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Lower Veterans Blood Pressure: Patient/Physician Intervention
- ClinicalTrials.gov ID
- NCT00105716
- Acronym / sponsor ID
- IIR 20-034
- Conditions
- Hypertension
- Keywords
- hypertension, adherence, cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2002
- Study completion
- Apr 2005 (actual)
- First posted
- 17 Mar 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.
This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Detailed description
Background:
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension, yet only 31% have their blood pressure (BP) under effective control. Uncontrolled hypertension greatly increases the risk of stroke, CAD, renal failure, CHF, and mortality.
Objectives:
This four year study evaluated simultaneously both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses were: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient behavioral/education intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Methods:
This was a randomized controlled trial with a split-plot design. Thirty primary care providers in the Durham VAMC Primary Care Clinic were randomly assigned to receive either the provider intervention or basic patient information; 588 of their hypertensive patients were randomized to the patient intervention or usual care. The provider intervention (ATHENA study (IIR 99-275) included an electronically generated hypertension decision support system (DSS) delivered to the provider at each hypertensive patient's visit. The provider intervention was designed to improve guideline concordant therapy. The patient intervention was a tailored behavioral/education intervention administered at periodic telephone contacts. The intervention included support and reminders, information on hypertension and on health behaviors. Patients received feedback about their recent BP values, continuous patient education, and were monitored and supported to enhance adherence. The control group was usual care.
Status:
Complete. Major activities completed in the past 12 months include submission of a manuscript describing the study, the interventions, and baseline and follow-up analyses. Secondary analyses are being completed which will be included in additional manuscripts.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Telephone behavioral education, Behavioral: Computer behavioral education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- >1 ICD9 Diagnosis 401.0, 401.1, 401.9
- Designated Primary Care Provider
- >1 Primary Care visit between 1/01/01-12/31/01
- Restricted to NC and VA addresses
- >1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805
Key exclusion criteria (9 listed)
- Dialysis patient
- Hospitalization for stroke in prior 3 months
- Myocardial infarction in prior 3 months
- Coronary artery revascularization in prior 3 months
- Metastatic cancer diagnosis in prior 3 months
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 |
|---|---|---|
| Telephone behavioral education | Behavioural | Arm 1 |
| Computer behavioral education | Behavioural | Arm 1 |
Primary outcome
BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
1 secondary outcome
Knowledge and perceived risks associated with hypertension and ability to continue hypertension regimen will be assessed at baseline and via telephone 6 and 24 months after baseline; Medication adherence will be assessed from pharmacy records
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 7 Apr 2015.
- Results publication: PubMed 20691830Datta SK, Oddone EZ, Olsen MK, Orr M, McCant F, Gentry P, Bosworth HB. Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients. Am Heart J. 2010 Aug;160(2):257-63. doi: 10.1016/j.ahj.2010.05.024.
- Results publication: PubMed 19559166Powers BJ, Olsen MK, Oddone EZ, Bosworth HB. The effect of a hypertension self-management intervention on diabetes and cholesterol control. Am J Med. 2009 Jul;122(7):639-46. doi: 10.1016/j.amjmed.2008.12.022.
- Results publication: PubMed 19330891Thorpe CT, Bryson CL, Maciejewski ML, Bosworth HB. Medication acquisition and self-reported adherence in veterans with hypertension. Med Care. 2009 Apr;47(4):474-81. doi: 10.1097/mlr.0b013e31818e7d4d.
- Results publication: PubMed 19249414Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
- Results publication: PubMed 18947408Powers BJ, Olsen MK, Oddone EZ, Thorpe CT, Bosworth HB. Literacy and blood pressure--do healthcare systems influence this relationship? A cross-sectional study. BMC Health Serv Res. 2008 Oct 23;8:219. doi: 10.1186/1472-6963-8-219.
- Results publication: PubMed 18825655Olsen MK, DeLong ER, Oddone EZ, Bosworth HB. Strategies for analyzing multilevel cluster-randomized studies with binary outcomes collected at varying intervals of time. Stat Med. 2008 Dec 20;27(29):6055-71. doi: 10.1002/sim.3446.
- Results publication: PubMed 18401229Walsh JM, Sundaram V, McDonald K, Owens DK, Goldstein MK. Implementing effective hypertension quality improvement strategies: barriers and potential solutions. J Clin Hypertens (Greenwich). 2008 Apr;10(4):311-6. doi: 10.1111/j.1751-7176.2008.07425.x.
- Results publication: PubMed 17485968Cho AH, Voils CI, Yancy WS Jr, Oddone EZ, Bosworth HB. Does participatory decision making improve hypertension self-care behaviors and outcomes? J Clin Hypertens (Greenwich). 2007 May;9(5):330-6. doi: 10.1111/j.1524-6175.2007.06489.x.
- Results publication: PubMed 18401226Powers BJ, Oddone EZ, Grubber JM, Olsen MK, Bosworth HB. Perceived and actual stroke risk among men with hypertension. J Clin Hypertens (Greenwich). 2008 Apr;10(4):287-94. doi: 10.1111/j.1751-7176.2008.07797.x.
- Results publication: PubMed 17238390Lin ND, Martins SB, Chan AS, Coleman RW, Bosworth HB, Oddone EZ, Shankar RD, Musen MA, Hoffman BB, Goldstein MK. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. AMIA Annu Symp Proc. 2006;2006:494-8.
- Results publication: PubMed 15956238Lowry KP, Dudley TK, Oddone EZ, Bosworth HB. Intentional and unintentional nonadherence to antihypertensive medication. Ann Pharmacother. 2005 Jul-Aug;39(7-8):1198-203. doi: 10.1345/aph.1E594. Epub 2005 Jun 14.
- Results publication: PubMed 15837438Bosworth HB, Olsen MK, Goldstein MK, Orr M, Dudley T, McCant F, Gentry P, Oddone EZ. The veterans' study to improve the control of hypertension (V-STITCH): design and methodology. Contemp Clin Trials. 2005 Apr;26(2):155-68. doi: 10.1016/j.cct.2004.12.006.
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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.
Hayden B. Bosworth, PhD principal investigator
Durham VA Medical Center, Durham, NC
Eugene Z. Oddone, MD MHSc principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone behavioral education and Computer behavioral education 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 5 inclusion and 9 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 7 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?
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?
BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.. 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 NCT00105716, which also lists 18 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 7 Apr 2015.