- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01390272
Titrated Disease Management for Patients With Hypertension (TDM)
Randomized Trial of Titrated Disease Management for Patients With Hypertension
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Titration Intervention
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. |
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Other Names:
Monthly tailored RN delivered calls + home BP monitoring.
Other Names:
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
Other Names:
|
Active Comparator: LPN Control
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.
|
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
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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.
|
6 months
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Systolic Blood Pressure
Time Frame: 12 months
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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.
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12 months
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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.
|
18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Hypertension Control
Time Frame: Baseline
|
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.
|
Baseline
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Number of Participants With Hypertension Control
Time Frame: 6 months
|
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.
|
6 months
|
Number of Participants With Hypertension Control
Time Frame: 12 months
|
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.
|
12 months
|
Number of Participants With Hypertension Control
Time Frame: 18 months
|
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.
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18 months
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Cost Effectiveness
Time Frame: Over 18 months of study intervention
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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. |
Over 18 months of study intervention
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Number of Participants Who Did Not Achieve Medication Adherence
Time Frame: Baseline
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
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. |
Baseline
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Number of Participants Who Did Not Achieve Medication Adherence
Time Frame: 6 months
|
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
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. |
6 months
|
Number of Participants Who Did Not Achieve Medication Adherence
Time Frame: 12 months
|
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
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. |
12 months
|
Number of Participants Who Did Not Achieve Medication Adherence
Time Frame: 18 months
|
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
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. |
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: George L Jackson, PhD MHA, Durham VA Medical Center, Durham, NC
Publications and helpful links
General 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.
- Jackson 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 10-383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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