Cardiovascular DiseasesNCT00123058
Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
A study testing Nurse administered and BP Monitor in people with Cardiovascular Diseases and Heart Diseases, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Nurse administered and BP Monitor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 777 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2007
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visited Duke General Internal Medicine Primary Care Clinic at Pickett Road or Duke Outpatient Clinic between April 2003 and April 2004
- Diagnosed with high BP
- Currently residing in an eight county area, including Durham County, NC and surrounding counties
- Currently taking BP medication
- Receives most medical care at the Duke Primary Care clinics
- Able to speak and understand English over the phone
Who cannot join
- Diagnosed with dementia
- Diagnosed with Parkinson's Disease
- Diagnosed with atrial fibrillation
- Diagnosed with end stage kidney disease
- Hospitalized for stroke, heart attack, or coronary artery revascularization in the 3 months prior to study entry
- Diagnosed with metastatic cancer in the 3 months prior to study entry
Show all 12Show fewer
- Receiving kidney dialysis
- Pregnant or expecting to become pregnant in the 2 years following study entry
- Currently residing in a nursing home or receiving home health care
- Severely impaired speech or hearing
- Participating in another blood pressure study
- Has another family member participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Take Control of Your Blood Pressure (TCYB)
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
Read the detailed description
BACKGROUND:
High BP is a major health problem, which contributes to high levels of morbidity and mortality. Elevated BP levels are a major risk factor for stroke, coronary artery disease (CAD), congestive heart failure (CHF), and kidney disease. In the United States, stroke rates are no longer improving and CHF and kidney failure rates continue to increase. Despite the availability of effective treatment, only 25% of individuals with high BP are able to control it effectively. The reasons for poor BP control vary; however, a predominant reason is poor adherence to medication instructions and life-style modification recommendations. This study will address these two sources of poor BP control through a real world, multifaceted approach.
DESIGN NARRATIVE:
This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control. The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP. The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness, yet be easily integrated into the participant's medical care so as to enhance adherence with the prescribed treatment. The use of home BP monitors has been found to be associated with increased self management, medication adherence, and improved BP control.
Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program, home BP monitoring program, both programs, or regular medical care. Based on an initial assessment, participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence. This program will include support, reminders, and information on the risks of high BP, health behaviors, patient/doctor communication, literacy, and side effects. Participants will receive continuous education and will be monitored and supported to enhance medication adherence. Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians. The primary outcome will be whether or not the participant's BP is greater than 140/90 mm Hg (for non-diabetic individuals) or greater than 130/85 mm Hg (for diabetic individuals) at 6-month intervals over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each participant may have a different number of measurements, the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study will improve participants' management of high BP, decrease health care utilization, and subsequently improve BP control.
Additionally, a subset (n=250) of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programs's effect on both primary (blood pressure control) and secondary outcome measures (changes in hypertension risk perception,satisfaction with care, patient confidence following recommended regimen, and self-reported adherence to recommended regimens.) Masking for this is open label.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Nurse administered, BP Monitor
- Keywords
- Hypertension, Cariovascular Diseases, Health Illiteracy
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse administeredBehavioural
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
BP MonitorDevice
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Nurse administered | Experimental | Nurse Administered Intervention:
Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months. Receives: Behavioral: Nurse administered |
| Nurse & BP monitor | Experimental | Subjects received both a nurse administered behavioral intervention via telephone every 8 weeks for 24 months and a study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. Receives: Behavioral: Nurse administered; Device: BP Monitor |
| Usual Care | No intervention | Subjects received neither home BP monitor nor nurse phone intervention. |
| Home BP Monitor | Experimental | Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. Receives: Device: BP Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP measurement
Measured: Measured at 6 months
Secondary outcomes (4)
Satisfaction with care
Measured: Measured at 6 and 24 months
Risk associated with hypertension
Measured: Measured at 6 and 24 months
Self reported adherence
Measured: Measured at 6 and 24 months
Efficacy with treatment
Measured: Measured at 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pfizer
- Responsible party
- Sponsor
- Investigators
- Hayden B. Bosworth, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123058
- Sponsor's protocol ID
- Pro00005845
- Other IDs
- R01HL070713
- Status last verified
- Sep 2014
- First submitted
- 20 Jul 2005
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosworth HB, Olsen MK, Gentry P, Orr M, Dudley T, McCant F, Oddone EZ. Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Patient Educ Couns. 2005 Apr;57(1):5-14. doi: 10.1016/j.pec.2004.03.011.
PubMed 15797147Hong TB, Oddone EZ, Dudley TK, Bosworth HB. Subjective and objective evaluations of health among middle-aged and older veterans with hypertension. J Aging Health. 2005 Oct;17(5):592-608. doi: 10.1177/0898264305279780.
PubMed 16177452Kim JW, Bosworth HB, Voils CI, Olsen M, Dudley T, Gribbin M, Adams M, Oddone EZ. How well do clinic-based blood pressure measurements agree with the mercury standard? J Gen Intern Med. 2005 Jul;20(7):647-9. doi: 10.1111/j.1525-1497.2005.0105.x.
PubMed 16050862Hong TB, Franks MM, Gonzalez R, Keteyian SJ, Franklin BA, Artinian NT. A dyadic investigation of exercise support between cardiac patients and their spouses. Health Psychol. 2005 Jul;24(4):430-4. doi: 10.1037/0278-6133.24.4.430.
PubMed 16045379Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored feedback to patients and clinicians. Am Heart J. 2005 May;149(5):795-803. doi: 10.1016/j.ahj.2005.01.039. No abstract available.
PubMed 15894959Bosworth HB, Bartash RM, Olsen MK, Steffens DC. The association of psychosocial factors and depression with hypertension among older adults. Int J Geriatr Psychiatry. 2003 Dec;18(12):1142-8. doi: 10.1002/gps.1026.
PubMed 14677147Trivedi RB, Ayotte B, Edelman D, Bosworth HB. The association of emotional well-being and marital status with treatment adherence among patients with hypertension. J Behav Med. 2008 Dec;31(6):489-97. doi: 10.1007/s10865-008-9173-4. Epub 2008 Sep 9.
PubMed 18780175Bosworth HB, Powers B, Grubber JM, Thorpe CT, Olsen MK, Orr M, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. J Gen Intern Med. 2008 May;23(5):692-8. doi: 10.1007/s11606-008-0547-7. Epub 2008 Feb 21.
PubMed 18288540Powers 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 18401226Ayotte BJ, Allaire JC, Bosworth H. The associations of patient demographic characteristics and health information recall: the mediating role of health literacy. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2009 Jul;16(4):419-32. doi: 10.1080/13825580902741336. Epub 2009 May 8.
PubMed 19424920Voils CI, Sandelowski M, Dahm P, Blouin R, Bosworth HB, Oddone EZ, Steinhauser KE. Selective adherence to antihypertensive medications as a patient-driven means to preserving sexual potency. Patient Prefer Adherence. 2008 Feb 2;2:201-6. doi: 10.2147/ppa.s3796.
PubMed 19920964Reed SD, Li Y, Oddone EZ, Neary AM, Orr MM, Grubber JM, Graham FL, Olsen MK, Svetkey LP, Dolor RJ, Powers BJ, Adams MB, Bosworth HB. Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension. Am J Hypertens. 2010 Feb;23(2):142-8. doi: 10.1038/ajh.2009.215. Epub 2009 Nov 19.
PubMed 19927132Trivedi RB, Ayotte BJ, Thorpe CT, Edelman D, Bosworth HB. Is there a nonadherent subtype of hypertensive patient? A latent class analysis approach. Patient Prefer Adherence. 2010 Jul 21;4:255-62. doi: 10.2147/ppa.s11335.
PubMed 20694185Bosworth HB, Olsen MK, Dudley T, Orr M, Neary A, Harrelson M, Adams M, Svetkey LP, Dolor RJ, Oddone EZ. The Take Control of Your Blood pressure (TCYB) study: study design and methodology. Contemp Clin Trials. 2007 Jan;28(1):33-47. doi: 10.1016/j.cct.2006.08.006. Epub 2006 Aug 16.
PubMed 16996808Bosworth HB, Olsen MK, Neary A, Orr M, Grubber J, Svetkey L, Adams M, Oddone EZ. Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored behavioral and educational intervention for achieving blood pressure control. Patient Educ Couns. 2008 Mar;70(3):338-47. doi: 10.1016/j.pec.2007.11.014. Epub 2007 Dec 31.
PubMed 18164894
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Control of Your Blood Pressure (TCYB)
- ClinicalTrials.gov ID
- NCT00123058
- Acronym / sponsor ID
- Pro00005845
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Keywords
- Hypertension, Cariovascular Diseases, Health Illiteracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pfizer
- Study start
- Jun 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Jul 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.
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
Detailed description
BACKGROUND:
High BP is a major health problem, which contributes to high levels of morbidity and mortality. Elevated BP levels are a major risk factor for stroke, coronary artery disease (CAD), congestive heart failure (CHF), and kidney disease. In the United States, stroke rates are no longer improving and CHF and kidney failure rates continue to increase. Despite the availability of effective treatment, only 25% of individuals with high BP are able to control it effectively. The reasons for poor BP control vary; however, a predominant reason is poor adherence to medication instructions and life-style modification recommendations. This study will address these two sources of poor BP control through a real world, multifaceted approach.
DESIGN NARRATIVE:
This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control. The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP. The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness, yet be easily integrated into the participant's medical care so as to enhance adherence with the prescribed treatment. The use of home BP monitors has been found to be associated with increased self management, medication adherence, and improved BP control.
Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program, home BP monitoring program, both programs, or regular medical care. Based on an initial assessment, participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence. This program will include support, reminders, and information on the risks of high BP, health behaviors, patient/doctor communication, literacy, and side effects. Participants will receive continuous education and will be monitored and supported to enhance medication adherence. Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians. The primary outcome will be whether or not the participant's BP is greater than 140/90 mm Hg (for non-diabetic individuals) or greater than 130/85 mm Hg (for diabetic individuals) at 6-month intervals over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each participant may have a different number of measurements, the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study will improve participants' management of high BP, decrease health care utilization, and subsequently improve BP control.
Additionally, a subset (n=250) of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programs's effect on both primary (blood pressure control) and secondary outcome measures (changes in hypertension risk perception,satisfaction with care, patient confidence following recommended regimen, and self-reported adherence to recommended regimens.) Masking for this is open label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nurse administered | Experimental | Behavioral: Nurse administeredNurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months. |
| Nurse & BP monitor | Experimental | Behavioral: Nurse administered, Device: BP MonitorSubjects received both a nurse administered behavioral intervention via telephone every 8 weeks for 24 months and a study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. |
| Usual Care | No intervention | –Subjects received neither home BP monitor nor nurse phone intervention. |
| Home BP Monitor | Experimental | Device: BP MonitorSubject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Visited Duke General Internal Medicine Primary Care Clinic at Pickett Road or Duke Outpatient Clinic between April 2003 and April 2004
- Diagnosed with high BP
- Currently residing in an eight county area, including Durham County, NC and surrounding counties
- Currently taking BP medication
- Receives most medical care at the Duke Primary Care clinics
Key exclusion criteria (12 listed)
- Diagnosed with dementia
- Diagnosed with Parkinson's Disease
- Diagnosed with atrial fibrillation
- Diagnosed with end stage kidney disease
- Hospitalized for stroke, heart attack, or coronary artery revascularization in the 3 months prior to study entry
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 |
|---|---|---|
| Nurse administeredSubjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months. | Behavioural | Nurse & BP monitor, Nurse administered |
| BP MonitorSubjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months. | Device | Home BP Monitor, Nurse & BP monitor |
Primary outcome
BP measurement
Time frame: Measured at 6 months
4 secondary outcomes
Satisfaction with care
Time frame: Measured at 6 and 24 months
Risk associated with hypertension
Time frame: Measured at 6 and 24 months
Self reported adherence
Time frame: Measured at 6 and 24 months
Efficacy with treatment
Time frame: Measured at 6 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Background: PubMed 15797147Bosworth HB, Olsen MK, Gentry P, Orr M, Dudley T, McCant F, Oddone EZ. Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Patient Educ Couns. 2005 Apr;57(1):5-14. doi: 10.1016/j.pec.2004.03.011.
- Background: PubMed 16177452Hong TB, Oddone EZ, Dudley TK, Bosworth HB. Subjective and objective evaluations of health among middle-aged and older veterans with hypertension. J Aging Health. 2005 Oct;17(5):592-608. doi: 10.1177/0898264305279780.
- Background: PubMed 16050862Kim JW, Bosworth HB, Voils CI, Olsen M, Dudley T, Gribbin M, Adams M, Oddone EZ. How well do clinic-based blood pressure measurements agree with the mercury standard? J Gen Intern Med. 2005 Jul;20(7):647-9. doi: 10.1111/j.1525-1497.2005.0105.x.
- Background: PubMed 16045379Hong TB, Franks MM, Gonzalez R, Keteyian SJ, Franklin BA, Artinian NT. A dyadic investigation of exercise support between cardiac patients and their spouses. Health Psychol. 2005 Jul;24(4):430-4. doi: 10.1037/0278-6133.24.4.430.
- Background: PubMed 15894959Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored feedback to patients and clinicians. Am Heart J. 2005 May;149(5):795-803. doi: 10.1016/j.ahj.2005.01.039. No abstract available.
- Background: PubMed 14677147Bosworth HB, Bartash RM, Olsen MK, Steffens DC. The association of psychosocial factors and depression with hypertension among older adults. Int J Geriatr Psychiatry. 2003 Dec;18(12):1142-8. doi: 10.1002/gps.1026.
- Background: PubMed 18780175Trivedi RB, Ayotte B, Edelman D, Bosworth HB. The association of emotional well-being and marital status with treatment adherence among patients with hypertension. J Behav Med. 2008 Dec;31(6):489-97. doi: 10.1007/s10865-008-9173-4. Epub 2008 Sep 9.
- Background: PubMed 18288540Bosworth HB, Powers B, Grubber JM, Thorpe CT, Olsen MK, Orr M, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. J Gen Intern Med. 2008 May;23(5):692-8. doi: 10.1007/s11606-008-0547-7. Epub 2008 Feb 21.
- Background: 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.
- Background: PubMed 19424920Ayotte BJ, Allaire JC, Bosworth H. The associations of patient demographic characteristics and health information recall: the mediating role of health literacy. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2009 Jul;16(4):419-32. doi: 10.1080/13825580902741336. Epub 2009 May 8.
- Background: PubMed 19920964Voils CI, Sandelowski M, Dahm P, Blouin R, Bosworth HB, Oddone EZ, Steinhauser KE. Selective adherence to antihypertensive medications as a patient-driven means to preserving sexual potency. Patient Prefer Adherence. 2008 Feb 2;2:201-6. doi: 10.2147/ppa.s3796.
- Background: PubMed 19927132Reed SD, Li Y, Oddone EZ, Neary AM, Orr MM, Grubber JM, Graham FL, Olsen MK, Svetkey LP, Dolor RJ, Powers BJ, Adams MB, Bosworth HB. Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension. Am J Hypertens. 2010 Feb;23(2):142-8. doi: 10.1038/ajh.2009.215. Epub 2009 Nov 19.
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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 principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse administered and BP Monitor in people with Cardiovascular Diseases and Heart Diseases, run by Duke University 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 6 inclusion and 12 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 8 Sep 2014. 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 measurement (time frame: Measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123058, which also lists 17 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 8 Sep 2014.