Cardiovascular DiseasesNCT00201201
Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
A study testing Education Intervention in people with Cardiovascular Diseases and Heart Diseases, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to reduce adverse self-medication practices in older adults with hypertension. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adult diagnosed with hypertension
- Health literacy score (REALM) of 44 or greater
- Independent physical and cognitive functioning
- Visual acuity of at least 20/100, with corrective lenses
- Affiliated with ProHealth Physicians, Inc. practice site in CT and/or
- Affiliated with APRN practice sites in CT
Who cannot join
- less than age 60
- health literacy score below 44 (6th grade)
- not currently prescribed antihypertensive medication
- visual acuity of less than 20/100 (with corrective lenses, if needed)
- inability to meet independent-living and cognitive-functioning ability.
- Not affiliated with primary care practice sites in CT
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
The purpose of this study is to reduce adverse self-medication practices in older adults with hypertension.
Read the detailed description
BACKGROUND:
Failure of older adults to take medications properly is estimated to be a factor in more than a quarter of emergency room visits and 10 percent of nursing home admissions, with a total cost of over $25 billion annually. It has been estimated that 10 percent of adverse drug events may be attributed to communication failure between the provider and patient. Lack of adherence to prescription medication protocols and adverse self-medication practices can result in drug interactions that can be fatal. In a health environment that promotes polypharmacy for older adults, a group that is less well able to see, hear, and understand medical information than the general population, a need exists to educate both older adults and their providers about the dangers of adverse drug interactions arising from self-medication.
DESIGN NARRATIVE:
The goal is to reduce adverse self-medication practices in older adults with hypertension. A computer program developed for older adults (Personal Education Program or PEP) will be modified as the next generation PEP, (PEP-NG), to include an interface to allow clients to enter self-medication behavior data independently on a wireless, touch screen tablet computer. Data entered on the PEP-NG will be analyzed via a secure server (ProHealth) and program content tailored to the specific adverse self-medication behaviors will be delivered. Summaries of the reported behaviors with corrective strategies will be printed for both patient and provider so the advanced practice registered nurse (APRN) has a good idea of the client's self-medication practices before beginning the face-to-face interview. Thus, the PEP-NG will make optimal use of the client's waiting time and the APRN's clinical time.
Specific aims are at three levels. 1) To design an interface for the PEP-NG with: a) desirable characteristics for both older adults and primary care providers; and b) minimal user burden. 2) To show that APRNs will increase: a) knowledge concerning potential drug interactions arising from older adults' self-medication practices; b) self-efficacy for teaching older adults about potential drug interactions; c) self-efficacy for communicating with older adults about self-medication; and to d) demonstrate satisfaction using the PEP-NG with clients. 3) To show that older adults using the PEP-NG will: a) increase knowledge concerning potential drug interactions arising from self-medication practices; b) increase self-efficacy as to how to avoid potential drug interactions arising from self-medication practice; c) reduce self-reported adverse behaviors associated with potential drug interactions; 4) improve prescription medication adherence; d) achieve target blood pressure readings; and demonstrate e) satisfaction with the PEP-NG and f) the APRN provider relationship. User-sensitive inclusive design methods will be used to develop and test the patient data interface. After beta-testing the PEP-NG in the primary care laboratory, the PEP-NG will be piloted by 10 APRNs affiliated with ProHealth primary care practices. Repeated Measures Analysis of Variance (RM ANOVA) with one within subjects factor (TIME) will be performed on APRNs' outcome measures at time 0, immediate post-instruction, and 3 and 6 months later. APRNs will each recruit 24 clients (240 total) meeting study criteria. The PEP-NG software will randomly assign each APRN's clients to either control (data collection only) and experimental (data collection plus educational intervention with targeted messages). Client outcome will be assessed at 0, 4, 8, 12, and 52 weeks and analyzed as a mixed ANOVA with NURSE and GROUP as between-subjects factors and TIME as a repeated-measures factor. Healthcare utilization will be compared between the 2 groups after 52 weeks and a cost-benefit analysis conducted.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Education Intervention, Control
- Keywords
- Older Adults, Primary Care, Hypertension, Adherence
- 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.
Education InterventionOther
Also called Personal Education Program - Next Generation (PEP-NG)
Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program.
ControlOther
Also called Control group for PEP-NG
Control group receiving care as usual after interfacing with the surveys on the PEP-NG
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | PEP-NG targeted and tailored education intervention Receives: Other: Education Intervention |
| Control | Other | Control, intervention is care as usual. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviors Risk Score
Using a five-point scale from 1, "very unlikely" to 5, "very likely," a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors.
Measured: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4
Blood Pressure (BP) Readings: Systolic Blood Pressure
BP measurements were taken by the APRN at each of 4 visits - at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.
Measured: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4
Secondary outcomes (4)
Self-efficacy for Avoiding Adverse Self-medication Behaviors
The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, "Not Sure" to 5, "Totally Sure"). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors.
Measured: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4
Prescription/Over the Counter (Rx-OTC) Knowledge
The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.
Measured: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4
Satisfaction With the PEP-NG
The PEP-NG user Satisfaction scale is a 14-item instrument - with eight items addressing the ease of program use, program content, and suitability of program content - and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, "strongly disagree" to 5, "strongly agree") were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG.
Measured: Measured at 12 weeks
Satisfaction With the APRN Provider Relationship
The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:"not at all easy" to 5: "very easy").
Measured: Measured at 0, 12 weeks on visit 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionJul 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 (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Patricia J. Neafsey, RD, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201201
- Sponsor's protocol ID
- H02-602
- Other IDs
- R01HL084208
- Status last verified
- Dec 2013
- First submitted
- 16 Sep 2005
- Last updated
- 3 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alicea-Planas, J., Neafsey, P.J., & Anderson, E. (2012). Using an e-health intervention to enhance patient visits for hypertension; The nurse practitioner perspective. Journal of Communication in Healthcare, 5(4), 239-249.
Lin CA, Neafsey PJ, Anderson E. Advanced practice registered nurse usability testing of a tailored computer-mediated health communication program. Comput Inform Nurs. 2010 Jan-Feb;28(1):32-41. doi: 10.1097/NCN.0b013e3181c0484e.
PubMed 19940619Neafsey PJ, Anderson E, Coleman C, Lin CA, M'lan CE, Walsh S. Reducing adverse self-medication behaviors in older adults with the Next Generation Personal Education Program (PEP-NG): Design and methodology. Patient Prefer Adherence. 2009 Nov 29;3:323-34. doi: 10.2147/ppa.s7906.
PubMed 20016796Lin CA, Neafsey PJ, Strickler Z. Usability testing by older adults of a computer-mediated health communication program. J Health Commun. 2009 Mar;14(2):102-18. doi: 10.1080/10810730802659095.
PubMed 19283536Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.
PubMed 19047879Neafsey PJ, M'lan CE, Ge M, Walsh SJ, Lin CA, Anderson E. Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial. Ageing Int. 2011 Jun;36(2):159-191. doi: 10.1007/s12126-010-9085-9. Epub 2010 Dec 8.
PubMed 21654869Anderson EH, Neafsey PJ, Peabody S. Psychometrics of the computer-based Relationships with Health Care Provider Scale in older adults. J Nurs Meas. 2011;19(1):3-16. doi: 10.1891/1061-3749.19.1.3.
PubMed 21560897Alicea-Planas J, Neafsey PJ, Anderson E. A Qualitative Study of Older Adults and Computer Use for Health Education: "It opens people's eyes". J Commun Healthc. 2011 Apr 1;4(1):38-45. doi: 10.1179/175380611X12950033990179.
PubMed 23243465Strickler, Z., Lin, C., Rauh, C. & Neafsey, P.J. (2008). Educating older adults to avoid harmful self-medication. Journal of Communication in Healthcare, 1(1), 110-128.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
- ClinicalTrials.gov ID
- NCT00201201
- Acronym / sponsor ID
- H02-602
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Keywords
- Older Adults, Primary Care, Hypertension, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 3 Feb 2014
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 reduce adverse self-medication practices in older adults with hypertension.
Detailed description
BACKGROUND:
Failure of older adults to take medications properly is estimated to be a factor in more than a quarter of emergency room visits and 10 percent of nursing home admissions, with a total cost of over $25 billion annually. It has been estimated that 10 percent of adverse drug events may be attributed to communication failure between the provider and patient. Lack of adherence to prescription medication protocols and adverse self-medication practices can result in drug interactions that can be fatal. In a health environment that promotes polypharmacy for older adults, a group that is less well able to see, hear, and understand medical information than the general population, a need exists to educate both older adults and their providers about the dangers of adverse drug interactions arising from self-medication.
DESIGN NARRATIVE:
The goal is to reduce adverse self-medication practices in older adults with hypertension. A computer program developed for older adults (Personal Education Program or PEP) will be modified as the next generation PEP, (PEP-NG), to include an interface to allow clients to enter self-medication behavior data independently on a wireless, touch screen tablet computer. Data entered on the PEP-NG will be analyzed via a secure server (ProHealth) and program content tailored to the specific adverse self-medication behaviors will be delivered. Summaries of the reported behaviors with corrective strategies will be printed for both patient and provider so the advanced practice registered nurse (APRN) has a good idea of the client's self-medication practices before beginning the face-to-face interview. Thus, the PEP-NG will make optimal use of the client's waiting time and the APRN's clinical time.
Specific aims are at three levels. 1) To design an interface for the PEP-NG with: a) desirable characteristics for both older adults and primary care providers; and b) minimal user burden. 2) To show that APRNs will increase: a) knowledge concerning potential drug interactions arising from older adults' self-medication practices; b) self-efficacy for teaching older adults about potential drug interactions; c) self-efficacy for communicating with older adults about self-medication; and to d) demonstrate satisfaction using the PEP-NG with clients. 3) To show that older adults using the PEP-NG will: a) increase knowledge concerning potential drug interactions arising from self-medication practices; b) increase self-efficacy as to how to avoid potential drug interactions arising from self-medication practice; c) reduce self-reported adverse behaviors associated with potential drug interactions; 4) improve prescription medication adherence; d) achieve target blood pressure readings; and demonstrate e) satisfaction with the PEP-NG and f) the APRN provider relationship. User-sensitive inclusive design methods will be used to develop and test the patient data interface. After beta-testing the PEP-NG in the primary care laboratory, the PEP-NG will be piloted by 10 APRNs affiliated with ProHealth primary care practices. Repeated Measures Analysis of Variance (RM ANOVA) with one within subjects factor (TIME) will be performed on APRNs' outcome measures at time 0, immediate post-instruction, and 3 and 6 months later. APRNs will each recruit 24 clients (240 total) meeting study criteria. The PEP-NG software will randomly assign each APRN's clients to either control (data collection only) and experimental (data collection plus educational intervention with targeted messages). Client outcome will be assessed at 0, 4, 8, 12, and 52 weeks and analyzed as a mixed ANOVA with NURSE and GROUP as between-subjects factors and TIME as a repeated-measures factor. Healthcare utilization will be compared between the 2 groups after 52 weeks and a cost-benefit analysis conducted.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: Education InterventionPEP-NG targeted and tailored education intervention |
| Control | Other | Other: ControlControl, intervention is care as usual. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older adult diagnosed with hypertension
- Health literacy score (REALM) of 44 or greater
- Independent physical and cognitive functioning
- Visual acuity of at least 20/100, with corrective lenses
- Affiliated with ProHealth Physicians, Inc. practice site in CT and/or
Key exclusion criteria (6 listed)
- less than age 60
- health literacy score below 44 (6th grade)
- not currently prescribed antihypertensive medication
- visual acuity of less than 20/100 (with corrective lenses, if needed)
- inability to meet independent-living and cognitive-functioning ability.
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 |
|---|---|---|
| Education InterventionAlso: Personal Education Program - Next Generation (PEP-NG)Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program. | Other | Education |
| ControlAlso: Control group for PEP-NGControl group receiving care as usual after interfacing with the surveys on the PEP-NG | Other | Control |
Primary outcome
Behaviors Risk Score
Time frame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4
Using a five-point scale from 1, "very unlikely" to 5, "very likely," a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors.
Blood Pressure (BP) Readings: Systolic Blood Pressure
Time frame: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4
BP measurements were taken by the APRN at each of 4 visits - at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.
4 secondary outcomes
Self-efficacy for Avoiding Adverse Self-medication Behaviors
Time frame: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4
Prescription/Over the Counter (Rx-OTC) Knowledge
Time frame: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4
Satisfaction With the PEP-NG
Time frame: Measured at 12 weeks
Satisfaction With the APRN Provider Relationship
Time frame: Measured at 0, 12 weeks on visit 1 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAlicea-Planas, J., Neafsey, P.J., & Anderson, E. (2012). Using an e-health intervention to enhance patient visits for hypertension; The nurse practitioner perspective. Journal of Communication in Healthcare, 5(4), 239-249.
- Background: PubMed 19940619Lin CA, Neafsey PJ, Anderson E. Advanced practice registered nurse usability testing of a tailored computer-mediated health communication program. Comput Inform Nurs. 2010 Jan-Feb;28(1):32-41. doi: 10.1097/NCN.0b013e3181c0484e.
- Background: PubMed 20016796Neafsey PJ, Anderson E, Coleman C, Lin CA, M'lan CE, Walsh S. Reducing adverse self-medication behaviors in older adults with the Next Generation Personal Education Program (PEP-NG): Design and methodology. Patient Prefer Adherence. 2009 Nov 29;3:323-34. doi: 10.2147/ppa.s7906.
- Background: PubMed 19283536Lin CA, Neafsey PJ, Strickler Z. Usability testing by older adults of a computer-mediated health communication program. J Health Commun. 2009 Mar;14(2):102-18. doi: 10.1080/10810730802659095.
- Background: PubMed 19047879Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.
- Results publication: PubMed 21654869Neafsey PJ, M'lan CE, Ge M, Walsh SJ, Lin CA, Anderson E. Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial. Ageing Int. 2011 Jun;36(2):159-191. doi: 10.1007/s12126-010-9085-9. Epub 2010 Dec 8.
- Results publication: PubMed 21560897Anderson EH, Neafsey PJ, Peabody S. Psychometrics of the computer-based Relationships with Health Care Provider Scale in older adults. J Nurs Meas. 2011;19(1):3-16. doi: 10.1891/1061-3749.19.1.3.
- Results publication: PubMed 23243465Alicea-Planas J, Neafsey PJ, Anderson E. A Qualitative Study of Older Adults and Computer Use for Health Education: "It opens people's eyes". J Commun Healthc. 2011 Apr 1;4(1):38-45. doi: 10.1179/175380611X12950033990179.
- Results publicationStrickler, Z., Lin, C., Rauh, C. & Neafsey, P.J. (2008). Educating older adults to avoid harmful self-medication. Journal of Communication in Healthcare, 1(1), 110-128.
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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.
Patricia J. Neafsey, RD, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention in people with Cardiovascular Diseases and Heart Diseases, run by University of Connecticut 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 6 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 3 Feb 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?
Yes. Results are posted in the registry (first posted 3 Feb 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?
Behaviors Risk Score (time frame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4). The study lists 2 primary outcomes in all. 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 NCT00201201, which also lists 9 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 3 Feb 2014.