HypertensionPOWERNCT00571038
Working With Veterans Organizations to Improve Blood Pressure
A study testing Peer Led and Seminar in people with Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary purpose of this project is to establish the efficacy of a novel peer support intervention to reduce hypertension among members of veteran service organizations (VSOs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Peer Led and Seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Member of a post or auxiliary of a participating veterans' service organization or Elks Lodge in the 70 miles surrounding the Milwaukee VAMC.
- Hypertension as established by one of: a) Average systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 at two baseline visits; b) SBP greater than 130 or DBP greater than 90 at two baseline visits, plus patient report of diabetes mellitus and use of a hypoglycemic agent at the baseline visit; or c) self-reported hypertension plus self-reported current treatment with at least one antihypertensive drug at baseline visit.
- Willingness to sign informed consent document.
Who cannot join
- Medical or social condition preventing routine attendance at a monthly meeting.
- Inability to communicate with other post members because of language barrier or physical limitation (e.g., prior stroke).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
About this study
The primary purpose of this project is to establish the efficacy of a novel peer support intervention to reduce hypertension among members of veteran service organizations (VSOs). Specifically, we plan to demonstrate that veterans participating in a peer support intervention, as opposed to a purely didactic educational program, will have better blood pressure (BP) control, increased engagement in blood pressure lowering activities (such as exercise), and a more active stance as patients.
Read the detailed description
IMPACT ON VETERANS HEALTH It is anticipated that this intervention will help participating veterans achieve optimal hypertension (HTN) control. Doing so will reduce their risks for heart disease and stroke, and improve their quality of life. It is hoped that the collaborative nature of this intervention will strengthen the Department of Veterans Affairs (VA)'s ties to the veteran community, and establish important "partnerships for health." If successful, this intervention could serve as a model for managing chronic disease both within and outside the VA system.
BACKGROUND/RATIONALE Despite consensus that effective hypertension treatment reduces morbidity and mortality, many patients in the United States continue to have suboptimal blood pressure control. Even with the provider resources and motivated patients inherent in a randomized clinical trial, over a third of patients participating in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were not at their goal blood pressure of 140/90 after five years. Similarly, within the Veterans Integrated Service Network (VISN) 12 we have found that as many as 30% of patients with hypertension are above the target BP of 140/90, despite routine physician reminders to patients who are above these goals. Moreover, preliminary results of an internally funded randomized trial suggest minimal impact of further physician-focused interventions to reduce patients' blood pressure.
OBJECTIVES We will have two primary objectives. First, because the intervention proposed is novel, we believe we need to demonstrate its efficacy in a methodologically rigorous fashion. Specifically we plan to demonstrate that veterans participating in a peer support intervention will have improved blood pressure control, knowledge of blood pressure treatment, both generally and for themselves, and a more active stance as patients.
Second, we will carefully examine the process by which our intervention achieves these goals, including examining such key structural variables as the frequency of peer support meetings, attendance of participants at these meetings, and use of healthcare professional support by the group leaders. As part of this second objective, we also seek to understand the fidelity with which the peer leaders are to deliver the intervention, and the satisfaction of both support group participants and leaders with the intervention.
METHODS There are three primary activities in the present project.
First, academicians from the Clement J. Zablocki VA Medical Center (VAMC) are working with the Veterans of Foreign Wars (VFW) and other community groups to develop a community-academic partnership that follows the principles of community-based participatory research. This key activity is underway and will continue beyond the present period of funding. Second, the centerpiece of the present grant is a cluster randomized clinical trial (RCT) of the use of peer-led support groups to improve BP control in patients with hypertension. Fifty posts drawn from the VFW, American Legion, Vietnam Veterans Association, and National Association of Black Veterans will be randomly assigned to receive professionally delivered education regarding hypertension or to a peer support intervention. The third activity is an evaluation of the processes involved in delivering the peer support intervention that will allow for successful replication, or to provide insight into why the expected improvement in BP control did not occur.
- Conditions
- Hypertension
- Being tested
- Peer Led, Seminar
- Keywords
- Hypertension, Self-help groups, Community health networks, Health knowledge, attitudes, practice, Patient participation, Randomized clinical trial
- Medical subject headings
- Hypertension, Behavior, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer LedBehavioural
Also called Peer led education and support
Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
SeminarBehavioural
Also called Professional didactic education
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
| Study group | Role | What they receive |
|---|---|---|
| Peer Led | Experimental | Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members. Receives: Behavioral: Peer Led |
| Seminar | Active comparator | Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Receives: Behavioral: Seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
Mean/Standard Error (SE) change in systolic blood pressure
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Secondary outcomes (20)
Change in Diastolic Blood Pressure
Mean/SE change in diastolic blood pressure
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Weight
Mean/SE change in weight, measured in pounds (lbs)
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in BMI
Mean/SE change in Body Mass Index (BMI) (kg/m2)
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Health Status
Response to the question "How would you rate your general health status?". Response options are scored as follows.
- Excellent
- Very Good
- Good
- Fair
- Poor We report the change in health status from baseline to 12 months.
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Time Since Last Physician Visit
Change in mean # of months since last visit to a physician
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Non-Clinic Blood Pressure Checks
% reporting non-clinic blood pressure (BP) checks at least once a month
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Number of Blood Pressure Medications
Change in mean # of prescription blood pressure medications
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Hypertension Knowledge
Mean/SE change in score on:
Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Hypertension Attitudes
Mean/SE change in score on:
Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Satisfaction With Blood Pressure Treatment
Mean/SE change in score on:
Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Alcohol Use
Mean/SE change in score on:
Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Sodium Intake
Mean/SE change in score on:
Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Physical Activity Level
Mean/SE change in score on:
Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Daily Steps
Mean/SE change in # of steps per day (self report)
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Fruit and Vegetable Intake
Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Medication Adherence
Mean/SE change in score on:
Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Self Efficacy
Mean/SE change in score on:
Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Social Support
Mean/SE change in overall score on:
Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Health Opinions
Mean/SE change in overall score on:
Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Change in Patient Activation
Mean/SE change in score on:
Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)
Measured: 9/16/2008-8/9/2010; baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionDec 2010
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 (7)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
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Medical College of Wisconsin, Veterans of Foreign Wars USA, Vietnam Veterans of America, National Association of Black Veterans, Korea Veterans of America, Inc., Disabled American Veterans, AmVETS, Jewish War Veterans of the United States of America, The American Legion Department of Wisconsin, Wisconsin Elks Association (a branch of The Benevolent and Protective order of Elks of the United States of America)
- Responsible party
- Sponsor
- Investigators
- Jeffrey C Whittle, MD MPH, Principal investigator, Clement J. Zablocki VA Medical Center, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571038
- Sponsor's protocol ID
- IAB 06-086
- Acronym
- POWER
- Status last verified
- Aug 2014
- First submitted
- 7 Dec 2007
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rosenwald K, Ertl K, Fletcher KE, Whittle J. Patterns of arthritis medication use in a community sample. J Prim Care Community Health. 2012 Oct 1;3(4):272-7. doi: 10.1177/2150131912442388. Epub 2012 Apr 4.
PubMed 23804172Patterson L, Morzinski J, Ertl K, Wurm C, Hayes A, Whittle J. Engaging community-based veterans' organizations in health promotion programs. Fam Community Health. 2011 Oct-Dec;34(4):311-8. doi: 10.1097/FCH.0b013e31822b5425.
PubMed 21881418Whittle J, Fletcher KE, Morzinski J, Ertl K, Patterson L, Jensen W, Schapira MM. Ethical challenges in a randomized controlled trial of peer education among veterans service organizations. J Empir Res Hum Res Ethics. 2010 Dec;5(4):43-51. doi: 10.1525/jer.2010.5.4.43.
PubMed 21133786Shirk J, Fletcher K, Patterson L, Grippen A, Eastwood D, Whittle JC. Peer leader characteristics do not predict their ability to deliver a peer support intervention. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S347.
Hayes A, Morzinski J, Ertl K, Wurm C, Patterson L, Wilke N, Whittle J. Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. WMJ. 2010 Apr;109(2):85-90.
PubMed 20443327Whittle J, Schapira MM, Fletcher KE, Hayes A, Morzinski J, Laud P, Eastwood D, Ertl K, Patterson L, Mosack KE. A randomized trial of peer-delivered self-management support for hypertension. Am J Hypertens. 2014 Nov;27(11):1416-23. doi: 10.1093/ajh/hpu058. Epub 2014 Apr 22.
PubMed 24755206Whittle JC, Hayes A, Eastwood D, Morzinski J, Ertl K, Wurm C. Effect on health behaviors of a health promotion intervention delivered through veterans service organizations. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S264.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working With Veterans Organizations to Improve Blood Pressure
- ClinicalTrials.gov ID
- NCT00571038
- Acronym / sponsor ID
- POWER / IAB 06-086
- Conditions
- Hypertension
- Keywords
- Hypertension, Self-help groups, Community health networks, Health knowledge, attitudes, practice, Patient participation, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Medical College of Wisconsin, Veterans of Foreign Wars USA, Vietnam Veterans of America, National Association of Black Veterans, Korea Veterans of America, Inc., Disabled American Veterans, AmVETS, Jewish War Veterans of the United States of America, The American Legion Department of Wisconsin, Wisconsin Elks Association (a branch of The Benevolent and Protective order of Elks of the United States of America)
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Posted 11 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 primary purpose of this project is to establish the efficacy of a novel peer support intervention to reduce hypertension among members of veteran service organizations (VSOs). Specifically, we plan to demonstrate that veterans participating in a peer support intervention, as opposed to a purely didactic educational program, will have better blood pressure (BP) control, increased engagement in blood pressure lowering activities (such as exercise), and a more active stance as patients.
Detailed description
IMPACT ON VETERANS HEALTH It is anticipated that this intervention will help participating veterans achieve optimal hypertension (HTN) control. Doing so will reduce their risks for heart disease and stroke, and improve their quality of life. It is hoped that the collaborative nature of this intervention will strengthen the Department of Veterans Affairs (VA)'s ties to the veteran community, and establish important "partnerships for health." If successful, this intervention could serve as a model for managing chronic disease both within and outside the VA system.
BACKGROUND/RATIONALE Despite consensus that effective hypertension treatment reduces morbidity and mortality, many patients in the United States continue to have suboptimal blood pressure control. Even with the provider resources and motivated patients inherent in a randomized clinical trial, over a third of patients participating in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were not at their goal blood pressure of 140/90 after five years. Similarly, within the Veterans Integrated Service Network (VISN) 12 we have found that as many as 30% of patients with hypertension are above the target BP of 140/90, despite routine physician reminders to patients who are above these goals. Moreover, preliminary results of an internally funded randomized trial suggest minimal impact of further physician-focused interventions to reduce patients' blood pressure.
OBJECTIVES We will have two primary objectives. First, because the intervention proposed is novel, we believe we need to demonstrate its efficacy in a methodologically rigorous fashion. Specifically we plan to demonstrate that veterans participating in a peer support intervention will have improved blood pressure control, knowledge of blood pressure treatment, both generally and for themselves, and a more active stance as patients.
Second, we will carefully examine the process by which our intervention achieves these goals, including examining such key structural variables as the frequency of peer support meetings, attendance of participants at these meetings, and use of healthcare professional support by the group leaders. As part of this second objective, we also seek to understand the fidelity with which the peer leaders are to deliver the intervention, and the satisfaction of both support group participants and leaders with the intervention.
METHODS There are three primary activities in the present project.
First, academicians from the Clement J. Zablocki VA Medical Center (VAMC) are working with the Veterans of Foreign Wars (VFW) and other community groups to develop a community-academic partnership that follows the principles of community-based participatory research. This key activity is underway and will continue beyond the present period of funding. Second, the centerpiece of the present grant is a cluster randomized clinical trial (RCT) of the use of peer-led support groups to improve BP control in patients with hypertension. Fifty posts drawn from the VFW, American Legion, Vietnam Veterans Association, and National Association of Black Veterans will be randomly assigned to receive professionally delivered education regarding hypertension or to a peer support intervention. The third activity is an evaluation of the processes involved in delivering the peer support intervention that will allow for successful replication, or to provide insight into why the expected improvement in BP control did not occur.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Led | Experimental | Behavioral: Peer LedPost provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members. |
| Seminar | Active comparator | Behavioral: SeminarPost provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Member of a post or auxiliary of a participating veterans' service organization or Elks Lodge in the 70 miles surrounding the Milwaukee VAMC.
- Hypertension as established by one of: a) Average systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 at two baseline visits; b) SBP greater than 130 or DBP greater than 90 at two baseline visits, plus patient report of diabetes mellitus and use of a hypoglycemic agent at the baseline visit; or c) self-reported hypertension plus self-reported current treatment with at least one antihypertensive drug at baseline visit.
- Willingness to sign informed consent document.
Key exclusion criteria (2 listed)
- Medical or social condition preventing routine attendance at a monthly meeting.
- Inability to communicate with other post members because of language barrier or physical limitation (e.g., prior stroke).
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 |
|---|---|---|
| Peer LedAlso: Peer led education and supportPost provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members. | Behavioural | Peer Led |
| SeminarAlso: Professional didactic educationPost provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. | Behavioural | Seminar |
Primary outcome
Change in Systolic Blood Pressure
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/Standard Error (SE) change in systolic blood pressure
20 secondary outcomes
Change in Diastolic Blood Pressure
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Weight
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in BMI
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Health Status
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Time Since Last Physician Visit
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Non-Clinic Blood Pressure Checks
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Number of Blood Pressure Medications
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Hypertension Knowledge
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Hypertension Attitudes
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Satisfaction With Blood Pressure Treatment
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Alcohol Use
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Sodium Intake
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Physical Activity Level
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Daily Steps
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Fruit and Vegetable Intake
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Medication Adherence
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Self Efficacy
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Social Support
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Health Opinions
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in Patient Activation
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23804172Rosenwald K, Ertl K, Fletcher KE, Whittle J. Patterns of arthritis medication use in a community sample. J Prim Care Community Health. 2012 Oct 1;3(4):272-7. doi: 10.1177/2150131912442388. Epub 2012 Apr 4.
- Background: PubMed 21881418Patterson L, Morzinski J, Ertl K, Wurm C, Hayes A, Whittle J. Engaging community-based veterans' organizations in health promotion programs. Fam Community Health. 2011 Oct-Dec;34(4):311-8. doi: 10.1097/FCH.0b013e31822b5425.
- Background: PubMed 21133786Whittle J, Fletcher KE, Morzinski J, Ertl K, Patterson L, Jensen W, Schapira MM. Ethical challenges in a randomized controlled trial of peer education among veterans service organizations. J Empir Res Hum Res Ethics. 2010 Dec;5(4):43-51. doi: 10.1525/jer.2010.5.4.43.
- BackgroundShirk J, Fletcher K, Patterson L, Grippen A, Eastwood D, Whittle JC. Peer leader characteristics do not predict their ability to deliver a peer support intervention. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S347.
- Background: PubMed 20443327Hayes A, Morzinski J, Ertl K, Wurm C, Patterson L, Wilke N, Whittle J. Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. WMJ. 2010 Apr;109(2):85-90.
- Results publication: PubMed 24755206Whittle J, Schapira MM, Fletcher KE, Hayes A, Morzinski J, Laud P, Eastwood D, Ertl K, Patterson L, Mosack KE. A randomized trial of peer-delivered self-management support for hypertension. Am J Hypertens. 2014 Nov;27(11):1416-23. doi: 10.1093/ajh/hpu058. Epub 2014 Apr 22.
- Results publicationWhittle JC, Hayes A, Eastwood D, Morzinski J, Ertl K, Wurm C. Effect on health behaviors of a health promotion intervention delivered through veterans service organizations. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S264.
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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.
Jeffrey C Whittle, MD MPH principal investigator
Clement J. Zablocki VA Medical Center, Milwaukee, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Led and Seminar 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 2 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 24 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 11 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?
Change in Systolic Blood Pressure (time frame: 9/16/2008-8/9/2010; baseline and 12 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 NCT00571038, which also lists 7 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 24 Apr 2015.