Trial Outcomes & Findings for Trial of Low and High Intensity Strategies to Maintain BP Control (NCT NCT00760552)
NCT ID: NCT00760552
Last Updated: 2015-04-27
Results Overview
Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint-BP-will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
Measured at Baseline, and 6,12,18,24, and 30 months post baseline.
Results posted on
2015-04-27
Participant Flow
249 total were enrolled. 122 had controlled BP and did not participate in the trial. of the 127 who participated, 4 dropped prior to randomization.
Participant milestones
| Measure |
Arm 1
VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
|
Arm 2
VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
| Measure |
Arm 1
VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
|
Arm 2
VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
Baseline Characteristics
Trial of Low and High Intensity Strategies to Maintain BP Control
Baseline characteristics by cohort
| Measure |
Arm 1
n=61 Participants
VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
|
Arm 2
n=62 Participants
VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
62 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline, and 6,12,18,24, and 30 months post baseline.Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint-BP-will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).
Outcome measures
| Measure |
Arm 1
n=48 Participants
VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
|
Arm 2
n=52 Participants
VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.
|
|---|---|---|
|
Blood Pressure Change
Basline Systolic BP
|
148 mmHg
Standard Deviation 14
|
147 mmHg
Standard Deviation 12
|
|
Blood Pressure Change
Baseline Diastolic BP
|
79 mmHg
Standard Deviation 11
|
79 mmHg
Standard Deviation 10
|
|
Blood Pressure Change
6-month Systolic BP
|
134 mmHg
Standard Deviation 16
|
135 mmHg
Standard Deviation 14
|
|
Blood Pressure Change
6-month Diastolic BP
|
73 mmHg
Standard Deviation 12
|
74 mmHg
Standard Deviation 10
|
|
Blood Pressure Change
12-month Systolic BP
|
136 mmHg
Standard Deviation 17
|
135 mmHg
Standard Deviation 16
|
|
Blood Pressure Change
12-month Diastolic BP
|
75 mmHg
Standard Deviation 11
|
74 mmHg
Standard Deviation 10
|
|
Blood Pressure Change
18-month Systolic BP
|
135 mmHg
Standard Deviation 17
|
137 mmHg
Standard Deviation 18
|
|
Blood Pressure Change
18-month Diastolic BP
|
73 mmHg
Standard Deviation 9
|
75 mmHg
Standard Deviation 10
|
|
Blood Pressure Change
24-month Systolic BP
|
134 mmHg
Standard Deviation 17
|
135 mmHg
Standard Deviation 16
|
|
Blood Pressure Change
24-month Diastolic BP
|
73 mmHg
Standard Deviation 9
|
74 mmHg
Standard Deviation 9
|
|
Blood Pressure Change
30-month Systolic BP
|
131 mmHg
Standard Deviation 17
|
136 mmHg
Standard Deviation 17
|
|
Blood Pressure Change
30-month Diastolic BP
|
72 mmHg
Standard Deviation 11
|
73 mmHg
Standard Deviation 11
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=61 participants at risk
VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
|
Arm 2
n=62 participants at risk
VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.
|
|---|---|---|
|
General disorders
Drug--Participant Hospitalization
|
1.6%
1/61 • Number of events 1
All study participants are counted in the Number of Participants at Risk. No Other Adverse Events were observed.
|
0.00%
0/62
All study participants are counted in the Number of Participants at Risk. No Other Adverse Events were observed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place