HypertensionNCT00217334
Community Hypertension Assessment Trial (CHAT)
A study testing Volunteer-led pharmacy sessions with feedback to physicians in people with Hypertension, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Volunteer-led pharmacy sessions with feedback to physicians
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2002to Jan 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Non-academic (none of its members are full-time faculty members)
- Full-time
- Regular family practice in terms of size and case-mix
- Able to provide an electronic roster that includes a mailing address of their patients 65 years and older
- Community-dwelling
- 65 years or older
- Visited the practice at least once in the last year
- Considered regular patients by the physician
Who cannot join
- work in walk-in clinics or emergency departments
- about to retire
- work part-time
- fewer than 50 patients 65 years or older
- specialized practice profile
- Patients
Show all 11Show fewer
- Terminally ill
- Scheduled to have surgery during the program period
- Not mobile to visit the pharmacy
- Non-English-speaking and unable to attend with an English-speaking companion
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Trial of Community Pharmacy Blood Pressure Clinics Linked With Family Medicine Practices to Improve the Monitoring and Management of High Blood Pressure Among Older Adults
The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults.
Read the detailed description
Hypertension affects about 22% of Canadian adults and is a modifiable risk factor for cardiovascular disease. Most countries have increasing older adult populations and hypertension prevalence increases with age. However, the "rule of halves" still applies in many primary health care settings: half of the hypertensive patients are undiagnosed, half of the diagnosed patients are untreated, and half of the treated patients are uncontrolled.
Family physicians were randomly selected and approached to participate in CHAT. Paired cluster randomization was used, with practices as the unit of randomization. Data on blood pressure (BP) readings in the last year, diagnosis of hypertension, diagnosis of diabetes and/or target organ damage, and a current antihypertensive profile was extracted from the health records of 55 patients randomly selected in each practice. In practices allocated to the Intervention group, physicians sent a letter, with assistance from research staff, to invite all of their eligible patients 65 years and older to attend one or two BP sessions in nearby pharmacies. Inclusion criteria required that patients be regular patients in the practice, community-dwelling, and mobile/well enough to attend community sessions.
Public health authorities trained older adult volunteer peer health educators to assist patients at the sessions to accurately measure their BP using a validated automated device, and record BP readings and cardiovascular risk factors. The volunteers provided education about hypertension but did not perform a clinical function. A recommendation protocol ensured that the pharmacist and, if necessary, the physician was notified if patients had a very high BP or a very low BP accompanied by symptoms. A public health nurse was 'on-call' during the sessions in case clinical advice was needed. A volunteer coordinator facilitated the transfer of readings and patient-reported cardiovascular risk factors to physicians.
Accurate BP readings were obtained from the BPM-100 automated BP measuring device. Questionnaires were used to obtain self-report data on cardiovascular disease risk factors from patients, knowledge and attitudes about BP control from physicians, and attitudes and satisfaction with the program from peer health educators, pharmacists, and public health nurses.
The primary outcome measure followed an 'intention to treat' approach. The primary endpoint was the difference in the change from 12 months pre- to 12 months post-intervention in the proportion of eligible patients with a BP reading recorded in their health record with mean systolic <=140 mm Hg or mean diastolic <=90 mmHg; <=130 or <=80 if target organ damage or diabetes is present.
This trial is a collaboration by the Department of Family Medicine, McMaster University and the Elisabeth Bruyère Research Institute, a University of Ottawa and SCO Service Partnership.
- Conditions
- Hypertension
- Being tested
- Volunteer-led pharmacy sessions with feedback to physicians
- Keywords
- Hypertension, Cardiovascular diseases, Randomized controlled trial, Cluster randomization, Primary care
- 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.
Volunteer-led pharmacy sessions with feedback to physiciansBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change from baseline to 12 months exit
Assessment in the mean percent of patients with adequate
Assessment / blood pressure (BP) control in intervention compared to control practices
Secondary outcomes (3)
Percent of patients with mean BP 140-159 / 90-99
Percent of patients with mean BP 160-179 / 100-110
Percent of patients with mean BP >180 / >110
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Investigators
- Janusz A Kaczorowski, PhD, Principal investigator, McMaster UniversityLarry W Chambers, PhD, Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217334
- Sponsor's protocol ID
- 0517-149-02
- Other IDs
- CIHR MOP 57902, McMaster CSD 2001HO4527
- Status last verified
- Sep 2005
- First submitted
- 19 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Karwalajtys T, Kaczorowski J, Chambers LW, Levitt C, Dolovich L, McDonough B, Patterson C, Williams JE. A randomized trial of mail vs. telephone invitation to a community-based cardiovascular health awareness program for older family practice patients [ISRCTN61739603]. BMC Fam Pract. 2005 Aug 19;6:35. doi: 10.1186/1471-2296-6-35.
PubMed 16111487Chambers LW, Kaczorowski J, Levitt C, Karwalajtys T, McDonough B, Lewis J. Blood pressure self-monitoring in pharmacies. Building on existing resources. Can Fam Physician. 2002 Oct;48:1594-5, 1602-4. No abstract available.
PubMed 12449541Chambers LW, Kaczorowski J, Dolovich L, Karwalajtys T, Hall HL, McDonough B, Hogg W, Farrell B, Hendriks A, Levitt C. A community-based program for cardiovascular health awareness. Can J Public Health. 2005 Jul-Aug;96(4):294-8. doi: 10.1007/BF03405169.
PubMed 16625801
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of Community Pharmacy Blood Pressure Clinics Linked With Family Medicine Practices to Improve the Monitoring and Management of High Blood Pressure Among Older Adults
- ClinicalTrials.gov ID
- NCT00217334
- Acronym / sponsor ID
- 0517-149-02
- Conditions
- Hypertension
- Keywords
- Hypertension, Cardiovascular diseases, Randomized controlled trial, Cluster randomization, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Nov 2002
- Study completion
- Jan 2005
- First posted
- 22 Sep 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 Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults.
Detailed description
Hypertension affects about 22% of Canadian adults and is a modifiable risk factor for cardiovascular disease. Most countries have increasing older adult populations and hypertension prevalence increases with age. However, the "rule of halves" still applies in many primary health care settings: half of the hypertensive patients are undiagnosed, half of the diagnosed patients are untreated, and half of the treated patients are uncontrolled.
Family physicians were randomly selected and approached to participate in CHAT. Paired cluster randomization was used, with practices as the unit of randomization. Data on blood pressure (BP) readings in the last year, diagnosis of hypertension, diagnosis of diabetes and/or target organ damage, and a current antihypertensive profile was extracted from the health records of 55 patients randomly selected in each practice. In practices allocated to the Intervention group, physicians sent a letter, with assistance from research staff, to invite all of their eligible patients 65 years and older to attend one or two BP sessions in nearby pharmacies. Inclusion criteria required that patients be regular patients in the practice, community-dwelling, and mobile/well enough to attend community sessions.
Public health authorities trained older adult volunteer peer health educators to assist patients at the sessions to accurately measure their BP using a validated automated device, and record BP readings and cardiovascular risk factors. The volunteers provided education about hypertension but did not perform a clinical function. A recommendation protocol ensured that the pharmacist and, if necessary, the physician was notified if patients had a very high BP or a very low BP accompanied by symptoms. A public health nurse was 'on-call' during the sessions in case clinical advice was needed. A volunteer coordinator facilitated the transfer of readings and patient-reported cardiovascular risk factors to physicians.
Accurate BP readings were obtained from the BPM-100 automated BP measuring device. Questionnaires were used to obtain self-report data on cardiovascular disease risk factors from patients, knowledge and attitudes about BP control from physicians, and attitudes and satisfaction with the program from peer health educators, pharmacists, and public health nurses.
The primary outcome measure followed an 'intention to treat' approach. The primary endpoint was the difference in the change from 12 months pre- to 12 months post-intervention in the proportion of eligible patients with a BP reading recorded in their health record with mean systolic <=140 mm Hg or mean diastolic <=90 mmHg; <=130 or <=80 if target organ damage or diabetes is present.
This trial is a collaboration by the Department of Family Medicine, McMaster University and the Elisabeth Bruyère Research Institute, a University of Ottawa and SCO Service Partnership.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Non-academic (none of its members are full-time faculty members)
- Full-time
- Regular family practice in terms of size and case-mix
- Able to provide an electronic roster that includes a mailing address of their patients 65 years and older
- Community-dwelling
Key exclusion criteria (11 listed)
- work in walk-in clinics or emergency departments
- about to retire
- work part-time
- fewer than 50 patients 65 years or older
- specialized practice profile
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 |
|---|---|---|
| Volunteer-led pharmacy sessions with feedback to physicians | Behavioural | – |
Primary outcome
Difference in the change from baseline to 12 months exit
Assessment in the mean percent of patients with adequate
Assessment / blood pressure (BP) control in intervention compared to control practices
3 secondary outcomes
Percent of patients with mean BP 140-159 / 90-99
Percent of patients with mean BP 160-179 / 100-110
Percent of patients with mean BP >180 / >110
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 22 Sep 2005.
- Background: PubMed 16111487Karwalajtys T, Kaczorowski J, Chambers LW, Levitt C, Dolovich L, McDonough B, Patterson C, Williams JE. A randomized trial of mail vs. telephone invitation to a community-based cardiovascular health awareness program for older family practice patients [ISRCTN61739603]. BMC Fam Pract. 2005 Aug 19;6:35. doi: 10.1186/1471-2296-6-35.
- Background: PubMed 12449541Chambers LW, Kaczorowski J, Levitt C, Karwalajtys T, McDonough B, Lewis J. Blood pressure self-monitoring in pharmacies. Building on existing resources. Can Fam Physician. 2002 Oct;48:1594-5, 1602-4. No abstract available.
- Results publication: PubMed 16625801Chambers LW, Kaczorowski J, Dolovich L, Karwalajtys T, Hall HL, McDonough B, Hogg W, Farrell B, Hendriks A, Levitt C. A community-based program for cardiovascular health awareness. Can J Public Health. 2005 Jul-Aug;96(4):294-8. doi: 10.1007/BF03405169.
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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.
Janusz A Kaczorowski, PhD principal investigator
McMaster University
Larry W Chambers, PhD principal investigator
Bruyère Health Research Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer-led pharmacy sessions with feedback to physicians in people with Hypertension, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 8 inclusion and 11 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 22 Sep 2005. 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 Canada. 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?
Difference in the change from baseline to 12 months exit. The study lists 3 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 NCT00217334, which also lists 3 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 22 Sep 2005.