HypertensionTDMNCT01390272
Titrated Disease Management for Patients With Hypertension
A study testing Booster/ low resource, Medium/Level 1 resource intensity and High/Level 2 resource intensity in people with Hypertension, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Booster/ low resource, Medium/Level 1 resource intensity and High/Level 2 resource intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2012to 31 Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years.
- Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
- Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
- Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for >= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
- Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >= 130 mmHg over the past year may be approached.
- Patients must indicate that they both:
- Have a VA or affiliated clinic provider that they consider to be their main PCP.
- Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).
Who cannot join
- Active diagnosis of psychosis.
- Diagnosis of metastatic cancer.
- Type 1 diabetes
- Class IV congestive heart failure (CHF).
- Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are <= 15.
- Chronic obstructive pulmonary disease (COPD) requiring oxygen.
Show all 20Show fewer
- Resident in nursing home or receiving home healthcare.
- Patient is pregnant or reports planning to become pregnant in the next two years
- At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
- Planning to leave the area prior to the anticipated end of participation.
- Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.
- Does not have reasonable access to a telephone.
- Does not speak English.
- Severely impaired hearing or speech (Patients must be able to respond to phone calls.).
- Severely impaired vision (Patients must be able to read mailed material).
- Refusal or inability to provide informed consent and HIPAA authorization form.
- Arm size > 50 cm
- Unable to obtain (including by arm) valid blood pressure readings
- Inadequate mental status to complete the protocol, as judged by five or more errors on the Short Portable Mental Status Questionnaire (SPMSQ).
- Former, current or pending solid organ or bone marrow transplant patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Randomized Trial of Titrated Disease Management for Patients With Hypertension
This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.
Read the detailed description
Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).
- Conditions
- Hypertension
- Being tested
- Booster/ low resource, Medium/Level 1 resource intensity, High/Level 2 resource intensity
- Keywords
- Hypertension, Telephone, Disease Management, Veterans, Pharmacists, Nurses
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booster/ low resourceBehavioural
Also called Control Arm - Low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Booster/ low resourceBehavioural
Also called Intervention Arm - Booster
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Medium/Level 1 resource intensityBehavioural
Also called Intervention Arm - Level 1
Monthly tailored RN delivered calls + home BP monitoring.
High/Level 2 resource intensityBehavioural
Also called Intervention Arm - Level 2
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
| Study group | Role | What they receive |
|---|---|---|
| Titration Intervention | Experimental | The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].
Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.
High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.
Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control. Receives: Behavioral: Booster/ low resource; Behavioral: Medium/Level 1 resource intensity; Behavioral: High/Level 2 resource intensity |
| LPN Control | Active comparator | A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control. Receives: Behavioral: Booster/ low resource |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
Measured: Baseline
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
Measured: 6 months
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
Measured: 12 months
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
Measured: 18 months
Secondary outcomes (9)
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.
Measured: Baseline
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.
Measured: 6 months
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.
Measured: 12 months
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.
Measured: 18 months
Cost Effectiveness
One of our secondary research questions was: "If the intervention results in greater reduction in SBP than the control group, is it cost effective?"
Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate.
While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs.
Measured: Over 18 months of study intervention
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
- Do you ever forget to take your blood pressure medicine?
- Are you careless at times about taking your blood pressure medicine?
- When you feel better do you sometimes stop taking you blood pressure medicine?
- Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.
The numbers in the descriptive tables reflect number non-adherent.
Measured: Baseline
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
- Do you ever forget to take your blood pressure medicine?
- Are you careless at times about taking your blood pressure medicine?
- When you feel better do you sometimes stop taking you blood pressure medicine?
- Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.
The numbers in the descriptive tables reflect number non-adherent.
Measured: 6 months
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
- Do you ever forget to take your blood pressure medicine?
- Are you careless at times about taking your blood pressure medicine?
- When you feel better do you sometimes stop taking you blood pressure medicine?
- Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.
The numbers in the descriptive tables reflect number non-adherent.
Measured: 12 months
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
- Do you ever forget to take your blood pressure medicine?
- Are you careless at times about taking your blood pressure medicine?
- When you feel better do you sometimes stop taking you blood pressure medicine?
- Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.
The numbers in the descriptive tables reflect number non-adherent.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study start27 Jul 2012
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- George L Jackson, PhD MHA, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390272
- Sponsor's protocol ID
- IIR 10-383
- Acronym
- TDM
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2011
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
PubMed 27417982Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.
PubMed 29672720
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Titrated Disease Management for Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01390272
- Acronym / sponsor ID
- TDM / IIR 10-383
- Conditions
- Hypertension
- Keywords
- Hypertension, Telephone, Disease Management, Veterans, Pharmacists, Nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Jul 2012 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.
Detailed description
Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titration Intervention | Experimental | Behavioral: Booster/ low resource, Behavioral: Medium/Level 1 resource intensity, Behavioral: High/Level 2 resource intensityThe intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement]. Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring. High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management. Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control. |
| LPN Control | Active comparator | Behavioral: Booster/ low resourceA LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years.
- Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
- Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
- Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for >= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
- Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >= 130 mmHg over the past year may be approached.
Key exclusion criteria (20 listed)
- Active diagnosis of psychosis.
- Diagnosis of metastatic cancer.
- Type 1 diabetes
- Class IV congestive heart failure (CHF).
- Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are <= 15.
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 |
|---|---|---|
| Booster/ low resourceAlso: Control Arm - Low resourceA LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months. | Behavioural | LPN Control |
| Booster/ low resourceAlso: Intervention Arm - BoosterA LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months. | Behavioural | Titration Intervention |
| Medium/Level 1 resource intensityAlso: Intervention Arm - Level 1Monthly tailored RN delivered calls + home BP monitoring. | Behavioural | Titration Intervention |
| High/Level 2 resource intensityAlso: Intervention Arm - Level 2Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup). | Behavioural | Titration Intervention |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
Systolic Blood Pressure
Time frame: 6 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
Systolic Blood Pressure
Time frame: 12 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
Systolic Blood Pressure
Time frame: 18 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
9 secondary outcomes
Number of Participants With Hypertension Control
Time frame: Baseline
Number of Participants With Hypertension Control
Time frame: 6 months
Number of Participants With Hypertension Control
Time frame: 12 months
Number of Participants With Hypertension Control
Time frame: 18 months
Cost Effectiveness
Time frame: Over 18 months of study intervention
Number of Participants Who Did Not Achieve Medication Adherence
Time frame: Baseline
Number of Participants Who Did Not Achieve Medication Adherence
Time frame: 6 months
Number of Participants Who Did Not Achieve Medication Adherence
Time frame: 12 months
Number of Participants Who Did Not Achieve Medication Adherence
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27417982Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
- Results publication: PubMed 29672720Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
George L Jackson, PhD MHA principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booster/ low resource, Medium/Level 1 resource intensity and High/Level 2 resource intensity in people with Hypertension, run by VA Office of Research and Development 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 8 inclusion and 20 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 11 Feb 2019. 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 Feb 2019). 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?
Systolic Blood Pressure (time frame: Baseline). The study lists 4 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 NCT01390272, which also lists 2 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 11 Feb 2019.