Trial Outcomes & Findings for Hypertension Intervention Nurse Telemedicine Study (HINTS) (NCT NCT00237692)
NCT ID: NCT00237692
Last Updated: 2015-04-24
Results Overview
When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
591 participants
Primary outcome timeframe
Baseline
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Arm 1- Control
A group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Managment Int
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behavioral and Med Mgmt Int
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
148
|
149
|
147
|
|
Overall Study
6 Month f/u
|
132
|
134
|
135
|
134
|
|
Overall Study
12 Month f/u
|
137
|
127
|
132
|
127
|
|
Overall Study
18 Month f/u
|
124
|
131
|
126
|
122
|
|
Overall Study
COMPLETED
|
129
|
134
|
127
|
128
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
22
|
19
|
Reasons for withdrawal
| Measure |
Arm 1- Control
A group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Managment Int
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behavioral and Med Mgmt Int
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
5
|
3
|
|
Overall Study
Death
|
1
|
2
|
2
|
3
|
|
Overall Study
Excluded - did not meet criteria
|
4
|
3
|
5
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
10
|
4
|
Baseline Characteristics
Hypertension Intervention Nurse Telemedicine Study (HINTS)
Baseline characteristics by cohort
| Measure |
Arm 1- Control
n=147 Participants
A group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=148 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Managment Int
n=149 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behavioral and Med Mgmt Int
n=147 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
Total
n=591 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 11 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 11 • n=4 Participants
|
64 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
542 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
74 participants
n=5 Participants
|
78 participants
n=7 Participants
|
73 participants
n=5 Participants
|
64 participants
n=4 Participants
|
289 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
71 participants
n=5 Participants
|
66 participants
n=7 Participants
|
72 participants
n=5 Participants
|
76 participants
n=4 Participants
|
285 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=5 Participants
|
148 participants
n=7 Participants
|
149 participants
n=5 Participants
|
147 participants
n=4 Participants
|
591 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselineWhen patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Outcome measures
| Measure |
Arm 1- Control
n=147 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=148 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=149 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=147 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Estimated Percentage of Participants in Blood Pressure Control at Baseline
|
61 % of particpants w/ controlled BP
|
59 % of particpants w/ controlled BP
|
53 % of particpants w/ controlled BP
|
64 % of particpants w/ controlled BP
|
PRIMARY outcome
Timeframe: 6monthWhen patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Outcome measures
| Measure |
Arm 1- Control
n=132 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=134 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=135 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=134 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Estimated Percentage of Participants in Blood Pressure Control at 6 Months
|
58 % of particpants with controlled SBP
|
61 % of particpants with controlled SBP
|
65 % of particpants with controlled SBP
|
64 % of particpants with controlled SBP
|
PRIMARY outcome
Timeframe: 12 monthWhen patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Outcome measures
| Measure |
Arm 1- Control
n=137 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=127 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=132 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=127 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Estimated Percentage of Participants in Blood Pressure Control at 12 Months
|
60 % of particpants with controlled SBP
|
73 % of particpants with controlled SBP
|
73 % of particpants with controlled SBP
|
69 % of particpants with controlled SBP
|
PRIMARY outcome
Timeframe: 18 monthWhen patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Outcome measures
| Measure |
Arm 1- Control
n=124 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=131 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=126 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=122 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Estimated Percentage of Participants in Blood Pressure Control at 18 Months
|
62 % of particpants with controlled SBP
|
59 % of particpants with controlled SBP
|
64 % of particpants with controlled SBP
|
72 % of particpants with controlled SBP
|
PRIMARY outcome
Timeframe: BaselineBlood pressure measured at Baseline. BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.
Outcome measures
| Measure |
Arm 1- Control
n=147 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=148 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=149 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=147 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Blood Pressure Averages Systolic & Diastolic
Systolic BP
|
128 mmHg
Standard Deviation 17
|
129 mmHg
Standard Deviation 19
|
132 mmHg
Standard Deviation 21
|
127 mmHg
Standard Deviation 21
|
|
Blood Pressure Averages Systolic & Diastolic
Diastolic BP
|
78 mmHg
Standard Deviation 14
|
77 mmHg
Standard Deviation 12
|
78 mmHg
Standard Deviation 14
|
77 mmHg
Standard Deviation 13
|
PRIMARY outcome
Timeframe: 12-monthBlood pressure measured at 12 month. BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.
Outcome measures
| Measure |
Arm 1- Control
n=137 Participants
a group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=127 Participants
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Management Int
n=132 Participants
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behaviorial and Med Mgmt Int
n=127 Participants
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Blood Pressure Averages Systolic & Diastolic
Diastolic BP
|
75.6 mmHg
Standard Deviation .9
|
74.9 mmHg
Standard Deviation .9
|
74.6 mmHg
Standard Deviation .9
|
75.6 mmHg
Standard Deviation .9
|
|
Blood Pressure Averages Systolic & Diastolic
Systolic BP
|
127.1 mmHg
Standard Deviation 1.5
|
125.0 mmHg
Standard Deviation 1.5
|
124.7 mmHg
Standard Deviation 1.5
|
122.8 mmHg
Standard Deviation 1.5
|
Adverse Events
Arm 1- Control
Serious events: 43 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 - Nurse Behavioral Int
Serious events: 71 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3 - Nurse Med Managment Int
Serious events: 68 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4 - Combined Behavioral and Med Mgmt Int
Serious events: 60 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1- Control
n=147 participants at risk
A group of hypertensive patients who receive usual care
|
Arm 2 - Nurse Behavioral Int
n=148 participants at risk
Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
|
Arm 3 - Nurse Med Managment Int
n=149 participants at risk
Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
|
Arm 4 - Combined Behavioral and Med Mgmt Int
n=147 participants at risk
Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
w/recurrent nosebleed
|
0.00%
0/147 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.00%
0/149 • Overall length of study
|
0.00%
0/147 • Overall length of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Tx
|
0.00%
0/147 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
|
Blood and lymphatic system disorders
Circulatory
|
2.0%
3/147 • Number of events 4 • Overall length of study
|
4.1%
6/148 • Number of events 6 • Overall length of study
|
4.0%
6/149 • Number of events 7 • Overall length of study
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
|
Cardiac disorders
Coronary
|
6.1%
9/147 • Number of events 9 • Overall length of study
|
12.2%
18/148 • Number of events 21 • Overall length of study
|
13.4%
20/149 • Number of events 26 • Overall length of study
|
7.5%
11/147 • Number of events 18 • Overall length of study
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
2.7%
4/148 • Number of events 7 • Overall length of study
|
2.0%
3/149 • Number of events 3 • Overall length of study
|
2.0%
3/147 • Number of events 3 • Overall length of study
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/147 • Overall length of study
|
0.68%
1/148 • Number of events 2 • Overall length of study
|
1.3%
2/149 • Number of events 2 • Overall length of study
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
|
Endocrine disorders
Endocrine
|
2.7%
4/147 • Number of events 5 • Overall length of study
|
7.4%
11/148 • Number of events 18 • Overall length of study
|
4.7%
7/149 • Number of events 15 • Overall length of study
|
4.8%
7/147 • Number of events 7 • Overall length of study
|
|
Eye disorders
Eye
|
0.00%
0/147 • Overall length of study
|
0.00%
0/148 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
0.00%
0/147 • Overall length of study
|
|
Gastrointestinal disorders
Gastro-Intestinal
|
2.0%
3/147 • Number of events 3 • Overall length of study
|
10.1%
15/148 • Number of events 30 • Overall length of study
|
7.4%
11/149 • Number of events 17 • Overall length of study
|
4.1%
6/147 • Number of events 6 • Overall length of study
|
|
General disorders
General - ER visits
|
3.4%
5/147 • Number of events 5 • Overall length of study
|
1.4%
2/148 • Number of events 2 • Overall length of study
|
4.7%
7/149 • Number of events 8 • Overall length of study
|
2.0%
3/147 • Number of events 3 • Overall length of study
|
|
General disorders
General - Med-Refill
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
0.68%
1/147 • Number of events 2 • Overall length of study
|
|
General disorders
General - Med Side Effect
|
2.0%
3/147 • Number of events 3 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
2.7%
4/149 • Number of events 4 • Overall length of study
|
3.4%
5/147 • Number of events 5 • Overall length of study
|
|
Infections and infestations
Infections
|
6.1%
9/147 • Number of events 11 • Overall length of study
|
5.4%
8/148 • Number of events 9 • Overall length of study
|
8.1%
12/149 • Number of events 12 • Overall length of study
|
6.1%
9/147 • Number of events 17 • Overall length of study
|
|
Injury, poisoning and procedural complications
Injury
|
1.4%
2/147 • Number of events 2 • Overall length of study
|
0.00%
0/148 • Overall length of study
|
2.0%
3/149 • Number of events 3 • Overall length of study
|
1.4%
2/147 • Number of events 2 • Overall length of study
|
|
Nervous system disorders
Neurologic
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
5.4%
8/148 • Number of events 9 • Overall length of study
|
6.7%
10/149 • Number of events 11 • Overall length of study
|
3.4%
5/147 • Number of events 5 • Overall length of study
|
|
Eye disorders
Optometry
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
0.68%
1/148 • Number of events 2 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
|
Musculoskeletal and connective tissue disorders
Orthopedic Issues
|
7.5%
11/147 • Number of events 17 • Overall length of study
|
10.1%
15/148 • Number of events 22 • Overall length of study
|
12.1%
18/149 • Number of events 26 • Overall length of study
|
14.3%
21/147 • Number of events 30 • Overall length of study
|
|
Psychiatric disorders
Psychological
|
1.4%
2/147 • Number of events 3 • Overall length of study
|
3.4%
5/148 • Number of events 5 • Overall length of study
|
2.0%
3/149 • Number of events 4 • Overall length of study
|
2.0%
3/147 • Number of events 5 • Overall length of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.7%
4/147 • Number of events 5 • Overall length of study
|
11.5%
17/148 • Number of events 21 • Overall length of study
|
8.7%
13/149 • Number of events 20 • Overall length of study
|
6.1%
9/147 • Number of events 10 • Overall length of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Death
|
0.00%
0/147 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.00%
0/149 • Overall length of study
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
|
Renal and urinary disorders
Renal
|
0.00%
0/147 • Overall length of study
|
0.00%
0/148 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
0.00%
0/147 • Overall length of study
|
|
Renal and urinary disorders
Urology
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
1.4%
2/147 • Number of events 2 • Overall length of study
|
|
Vascular disorders
Vascular
|
1.4%
2/147 • Number of events 3 • Overall length of study
|
0.00%
0/148 • Overall length of study
|
0.00%
0/149 • Overall length of study
|
0.00%
0/147 • Overall length of study
|
|
Cardiac disorders
Coronary - Death
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
0.67%
1/149 • Number of events 1 • Overall length of study
|
1.4%
2/147 • Number of events 2 • Overall length of study
|
|
Cardiac disorders
Coronary Safety Protocol
|
0.68%
1/147 • Number of events 1 • Overall length of study
|
0.68%
1/148 • Number of events 1 • Overall length of study
|
2.7%
4/149 • Number of events 4 • Overall length of study
|
2.7%
4/147 • Number of events 4 • Overall length of study
|
Other adverse events
Adverse event data not reported
Additional Information
Hayden B. Bosworth, PhD
Center for Primary Care, HSRD COIN
Phone: 919-286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place