Trial Outcomes & Findings for A Behavioral Intervention To Improve Hypertension Control In Veterans (NCT NCT00286754)
NCT ID: NCT00286754
Last Updated: 2015-06-01
Results Overview
Blood pressure Control at 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
533 participants
Primary outcome timeframe
6 months
Results posted on
2015-06-01
Participant Flow
Participant milestones
| Measure |
Stage-matched Intervention (SM)
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
6 monthly phone calls of non-tailored counseling for diet, medication and exercise
|
Usual Care (UC)
treatment as usual with no additional counseling
|
|---|---|---|---|
|
Overall Study
STARTED
|
176
|
177
|
180
|
|
Overall Study
COMPLETED
|
156
|
159
|
170
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
10
|
Reasons for withdrawal
| Measure |
Stage-matched Intervention (SM)
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
6 monthly phone calls of non-tailored counseling for diet, medication and exercise
|
Usual Care (UC)
treatment as usual with no additional counseling
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
6
|
|
Overall Study
Moved out of state
|
0
|
0
|
1
|
Baseline Characteristics
A Behavioral Intervention To Improve Hypertension Control In Veterans
Baseline characteristics by cohort
| Measure |
Stage-Matched Intervention (SMI)
n=176 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=177 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=180 Participants
treatment as usual for hypertension
|
Total
n=533 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age and Standard Deviation
|
66.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 18.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
526 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White (non-Hispanic)
|
81 participants
n=5 Participants
|
60 participants
n=7 Participants
|
71 participants
n=5 Participants
|
212 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black (non-Hispanic)
|
65 participants
n=5 Participants
|
77 participants
n=7 Participants
|
70 participants
n=5 Participants
|
212 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
24 participants
n=5 Participants
|
29 participants
n=7 Participants
|
29 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Marital status
Married
|
59 participants
n=5 Participants
|
67 participants
n=7 Participants
|
70 participants
n=5 Participants
|
196 participants
n=4 Participants
|
|
Marital status
Not Married
|
117 participants
n=5 Participants
|
110 participants
n=7 Participants
|
110 participants
n=5 Participants
|
337 participants
n=4 Participants
|
|
Education
High school graduate or below
|
72 participants
n=5 Participants
|
89 participants
n=7 Participants
|
87 participants
n=5 Participants
|
248 participants
n=4 Participants
|
|
Education
Some college or higher
|
104 participants
n=5 Participants
|
88 participants
n=7 Participants
|
93 participants
n=5 Participants
|
285 participants
n=4 Participants
|
|
Employment status
Employed
|
29 participants
n=5 Participants
|
41 participants
n=7 Participants
|
41 participants
n=5 Participants
|
111 participants
n=4 Participants
|
|
Employment status
Not employed
|
147 participants
n=5 Participants
|
136 participants
n=7 Participants
|
139 participants
n=5 Participants
|
422 participants
n=4 Participants
|
|
Campus
Manhattan campus
|
96 participants
n=5 Participants
|
96 participants
n=7 Participants
|
97 participants
n=5 Participants
|
289 participants
n=4 Participants
|
|
Campus
Brooklyn campus
|
80 participants
n=5 Participants
|
81 participants
n=7 Participants
|
83 participants
n=5 Participants
|
244 participants
n=4 Participants
|
|
Smoking
Current smoker
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
99 participants
n=4 Participants
|
|
Smoking
Current non-smoker
|
141 participants
n=5 Participants
|
145 participants
n=7 Participants
|
148 participants
n=5 Participants
|
434 participants
n=4 Participants
|
|
Body mass index
|
30.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 5.3 • n=4 Participants
|
|
Blood pressure control
BP controlled
|
75 participants
n=5 Participants
|
72 participants
n=7 Participants
|
80 participants
n=5 Participants
|
227 participants
n=4 Participants
|
|
Blood pressure control
BP not controlled
|
101 participants
n=5 Participants
|
105 participants
n=7 Participants
|
100 participants
n=5 Participants
|
306 participants
n=4 Participants
|
|
Diabetes Mellitus
Diabetes mellitus
|
71 participants
n=5 Participants
|
83 participants
n=7 Participants
|
81 participants
n=5 Participants
|
235 participants
n=4 Participants
|
|
Diabetes Mellitus
No diabetes mellitus
|
105 participants
n=5 Participants
|
94 participants
n=7 Participants
|
99 participants
n=5 Participants
|
298 participants
n=4 Participants
|
|
Ischemic Heart Disease (IHD)
History of IHD
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
23 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Ischemic Heart Disease (IHD)
No history of IHD
|
153 participants
n=5 Participants
|
155 participants
n=7 Participants
|
157 participants
n=5 Participants
|
465 participants
n=4 Participants
|
|
History of revascularization
History of revascularization
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
History of revascularization
No history of revascularization
|
149 participants
n=5 Participants
|
149 participants
n=7 Participants
|
149 participants
n=5 Participants
|
447 participants
n=4 Participants
|
|
Hyperlipidemia
Hyperlipidemia
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
52 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Hyperlipidemia
No hyperlipidemia
|
137 participants
n=5 Participants
|
139 participants
n=7 Participants
|
128 participants
n=5 Participants
|
404 participants
n=4 Participants
|
|
Estimated glomerular filtration rate (EGFR)
|
79.9 mL/min/1.73m^2
STANDARD_DEVIATION 25.5 • n=5 Participants
|
83.2 mL/min/1.73m^2
STANDARD_DEVIATION 46.3 • n=7 Participants
|
80.6 mL/min/1.73m^2
STANDARD_DEVIATION 28.4 • n=5 Participants
|
81.3 mL/min/1.73m^2
STANDARD_DEVIATION 35.8 • n=4 Participants
|
|
Systolic Blood Pressure, mm Mg
|
136.0 mm Hg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
137.2 mm Hg
STANDARD_DEVIATION 17.7 • n=7 Participants
|
137.0 mm Hg
STANDARD_DEVIATION 12.9 • n=5 Participants
|
136.7 mm Hg
STANDARD_DEVIATION 15.5 • n=4 Participants
|
|
Diastolic blood pressure
|
75.5 mm Hg
STANDARD_DEVIATION 9.3 • n=5 Participants
|
76.1 mm Hg
STANDARD_DEVIATION 11.6 • n=7 Participants
|
75.0 mm Hg
STANDARD_DEVIATION 11.1 • n=5 Participants
|
75.5 mm Hg
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Aerobic exercise
|
5.3 hours per week
STANDARD_DEVIATION 8.1 • n=5 Participants
|
4.5 hours per week
STANDARD_DEVIATION 5.9 • n=7 Participants
|
5.0 hours per week
STANDARD_DEVIATION 6.7 • n=5 Participants
|
4.9 hours per week
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Medication adherence by Morisky scale
|
3.4 units on a scale
STANDARD_DEVIATION 0.93 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.94 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.88 • n=4 Participants
|
|
Number of antihypertensive medications
|
2.7 medications
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.8 medications
STANDARD_DEVIATION 1.3 • n=7 Participants
|
2.7 medications
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.7 medications
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Diet stage of change
Action or Maintenance
|
69 participants
n=5 Participants
|
67 participants
n=7 Participants
|
70 participants
n=5 Participants
|
206 participants
n=4 Participants
|
|
Diet stage of change
Precontemplation, Contemplation or Preparation
|
107 participants
n=5 Participants
|
110 participants
n=7 Participants
|
110 participants
n=5 Participants
|
327 participants
n=4 Participants
|
|
Exercise Stage of Change
Action or Maintenance
|
125 participants
n=5 Participants
|
110 participants
n=7 Participants
|
108 participants
n=5 Participants
|
343 participants
n=4 Participants
|
|
Exercise Stage of Change
Precontemplation, Contemplation, or Preparation
|
51 participants
n=5 Participants
|
67 participants
n=7 Participants
|
72 participants
n=5 Participants
|
190 participants
n=4 Participants
|
|
Medication Stage of Change
Action or Maintenance
|
164 participants
n=5 Participants
|
170 participants
n=7 Participants
|
166 participants
n=5 Participants
|
500 participants
n=4 Participants
|
|
Medication Stage of Change
Precontemplation, Contemplation or Preparation
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
33 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBlood pressure Control at 6 months
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Blood Pressure Control
BP not controlled
|
0.354 proportion of participants
|
0.457 proportion of participants
|
0.542 proportion of participants
|
|
Blood Pressure Control
BP controlled
|
0.646 proportion of participants
|
0.543 proportion of participants
|
0.458 proportion of participants
|
PRIMARY outcome
Timeframe: 6 monthsMean systolic Blood Pressure
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Systolic Blood Pressure
|
131.2 mm Hg
Interval 129.1 to 133.3
|
131.8 mm Hg
Interval 129.9 to 133.7
|
134.7 mm Hg
Interval 132.7 to 136.7
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Change in Proportion With BP Under Control From Baseline to 6 Months
|
.197 Proportion of participants
|
.118 Proportion of participants
|
.019 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 6 Months
|
-4.7 mm Hg
Interval -6.9 to -2.5
|
-5.4 mm Hg
Interval -8.5 to -2.3
|
-2.7 mm Hg
Interval -5.0 to -0.4
|
SECONDARY outcome
Timeframe: baseline and 6 monthsOutcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
|
-0.29 hours
Interval -1.7 to 1.1
|
0.53 hours
Interval -0.6 to 1.7
|
-0.43 hours
Interval -1.4 to 0.6
|
SECONDARY outcome
Timeframe: baseline and 6 monthsMorkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Change in Morisky Score From Baseline to 6 Months
|
0.25 units on a scale
Interval 0.1 to 0.4
|
0.25 units on a scale
Interval 0.1 to 0.4
|
0.14 units on a scale
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: 6 monthsThe stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Diet Stage of Change
Action or Maintenance
|
87 participants
|
73 participants
|
73 participants
|
|
Diet Stage of Change
Precontemplation, Contemplation or Preparation
|
69 participants
|
86 participants
|
97 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Exercise Stage of Change
Action or Maintenance
|
128 participants
|
124 participants
|
126 participants
|
|
Exercise Stage of Change
Precontemplation, Contemplation or Preparation
|
28 participants
|
35 participants
|
44 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.
Outcome measures
| Measure |
Stage-matched Intervention (SMI)
n=156 Participants
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=159 Participants
6 monthly calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=170 Participants
treatment as usual for hypertension
|
|---|---|---|---|
|
Medication Stage of Change
Action or Maintenance
|
148 participants
|
156 participants
|
163 participants
|
|
Medication Stage of Change
Precontemplation, Contemplation or Preparation
|
8 participants
|
3 participants
|
7 participants
|
Adverse Events
Stage-matched Intervention (SMI)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Health Education Intervention (HEI)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage-matched Intervention (SMI)
n=176 participants at risk
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=177 participants at risk
6 monthly phone calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=180 participants at risk
treatment as usual for hypertension
|
|---|---|---|---|
|
Cardiac disorders
Heart attack
|
1.1%
2/176 • Number of events 2 • 1 year
|
0.00%
0/177 • 1 year
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Vascular disorders
Stroke
|
0.00%
0/176 • 1 year
|
0.00%
0/177 • 1 year
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
General disorders
Death
|
0.57%
1/176 • Number of events 1 • 1 year
|
0.56%
1/177 • Number of events 1 • 1 year
|
0.00%
0/180 • 1 year
|
Other adverse events
| Measure |
Stage-matched Intervention (SMI)
n=176 participants at risk
6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
|
Health Education Intervention (HEI)
n=177 participants at risk
6 monthly phone calls of nontailored counseling for diet, medication and exercise
|
Usual Care (UC)
n=180 participants at risk
treatment as usual for hypertension
|
|---|---|---|---|
|
Cardiac disorders
Angina
|
2.8%
5/176 • Number of events 5 • 1 year
|
1.7%
3/177 • Number of events 3 • 1 year
|
2.2%
4/180 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
broken bones
|
2.8%
5/176 • Number of events 5 • 1 year
|
0.56%
1/177 • Number of events 1 • 1 year
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
torn ligament
|
1.1%
2/176 • Number of events 2 • 1 year
|
0.00%
0/177 • 1 year
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Cardiac disorders
hypertensive emergency
|
0.00%
0/176 • 1 year
|
0.56%
1/177 • Number of events 1 • 1 year
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
1.1%
2/176 • Number of events 2 • 1 year
|
1.1%
2/177 • Number of events 2 • 1 year
|
0.00%
0/180 • 1 year
|
Additional Information
Sundar Natarajan, MD, Staff Physician
Department of Veterans Affairs
Phone: 212-686-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place