Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286754
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2006-02-01
Brief Title:
A Behavioral Intervention To Improve Hypertension Control In Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Behavioral Intervention to Improve Hypertension Control in Veterans
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a stage-matched intervention SMI will lower BP and improve treatment adherence compared to usual care UC or a health education intervention HEI in veterans with uncontrolled BP The study will also examine the effect of SMI on patients health-related quality of life satisfaction acceptability and determine its cost-effectiveness
Detailed Description:
We propose a randomized controlled trial to evaluate the effect of telephone-delivered interventions SMI and HEI to improve BP control
Veterans with uncontrolled hypertension n533 will be randomized equally to 3 groups 1 The SMI will use the Transtheoretical model TTM as the unifying framework Veterans will receive TTM stage-matched counseling for exercise diet and medications via monthly counseling sessions A social worker SW will assess each participants behavior and deliver the appropriate tailored SMI based on their stage of change decisional balance self-efficacy and the skills model questions 2 The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management 3 The UC group participates in all the in-person visits but does not receive monthly calls
There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability All participants will visit the VAMCs at baseline and at 3 6 and 12 months Outcomes of interest include BP adherence to diet exercise and medications quality of life satisfaction acceptability cost and cost-effectiveness Patients will be blinded to which of the intervention arms SMI or HEI they are in SWs will be blinded to patients BP and staff measuring outcomes will be blinded to study assignment The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy
Veterans with uncontrolled hypertension n533 will be randomized equally to 3 groups 1 The SMI will use the Transtheoretical model TTM as the unifying framework Veterans will receive TTM stage-matched counseling for exercise diet and medications via monthly counseling sessions A social worker SW will assess each participants behavior and deliver the appropriate tailored SMI based on their stage of change decisional balance self-efficacy and the skills model questions 2 The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management 3 The UC group participates in all the in-person visits but does not receive monthly calls
There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability All participants will visit the VAMCs at baseline and at 3 6 and 12 months Outcomes of interest include BP adherence to diet exercise and medications quality of life satisfaction acceptability cost and cost-effectiveness Patients will be blinded to which of the intervention arms SMI or HEI they are in SWs will be blinded to patients BP and staff measuring outcomes will be blinded to study assignment The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None