Hypertension Intervention Nurse Telemedicine Study (HINTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237692
First received: October 7, 2005
Last updated: April 6, 2015
Last verified: August 2014
Results First Received: August 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring
Behavioral: Nurse Medication Management with Home BP Telemonitoring
Behavioral: Nurse Combined intervention with Home BP Telemonitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Arm 1- Control     Arm 2 - Nurse Behavioral Int     Arm 3 - Nurse Med Managment Int     Arm 4 - Combined Behavioral and Med Mgmt Int  
STARTED     147     148     149     147  
6 Month f/u     132     134     135     134  
12 Month f/u     137     127     132     127  
18 Month f/u     124     131     126     122  
COMPLETED     129     134     127     128  
NOT COMPLETED     18     14     22     19  
Lost to Follow-up                 9                 3                 5                 3  
Death                 1                 2                 2                 3  
Excluded - did not meet criteria                 4                 3                 5                 9  
Withdrawal by Subject                 4                 6                 10                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All data except blood pressure, age, gender were patient-reported.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Arm 1- Control     Arm 2 - Nurse Behavioral Int     Arm 3 - Nurse Med Managment Int     Arm 4 - Combined Behavioral and Med Mgmt Int     Total  
Number of Participants  
[units: participants]
  147     148     149     147     591  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 10     63  ± 11     64  ± 10     63  ± 11     64  ± 10  
Gender  
[units: participants]
         
Female     6     12     10     21     49  
Male     141     136     139     126     542  
Race/Ethnicity, Customized  
[units: participants]
         
Caucasian     74     78     73     64     289  
African American     71     66     72     76     285  
Other     2     4     4     7     17  
Region of Enrollment  
[units: participants]
         
United States     147     148     149     147     591  



  Outcome Measures
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1.  Primary:   Estimated Percentage of Participants in Blood Pressure Control at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Estimated Percentage of Participants in Blood Pressure Control at 6 Months   [ Time Frame: 6month ]

3.  Primary:   Estimated Percentage of Participants in Blood Pressure Control at 12 Months   [ Time Frame: 12 month ]

4.  Primary:   Estimated Percentage of Participants in Blood Pressure Control at 18 Months   [ Time Frame: 18 month ]

5.  Primary:   Blood Pressure Averages Systolic & Diastolic   [ Time Frame: Baseline ]

6.  Primary:   Blood Pressure Averages Systolic & Diastolic   [ Time Frame: 12-month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hayden B. Bosworth, PhD
Organization: Center for Primary Care, HSRD COIN
phone: 919-286-0411 ext 7107
e-mail: hayden.bosworth@va.gov


Publications of Results:

Other Publications:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237692     History of Changes
Other Study ID Numbers: IIR 04-426
Study First Received: October 7, 2005
Results First Received: August 29, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government