Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233220
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-10-03
Brief Title:
Blood Pressure Control in African Americans
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Multi-site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans
Status:
COMPLETED
Status Verified Date:
2014-02
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 test the effectiveness of a multi-component evidence-based intervention that targets both patients and physicians in improving BP control rates in patients followed in 30 CommunityMigrant Health Centers CMHCs
Detailed Description:
BACKGROUND
African Americans AA have the highest prevalence of hypertension HTN in the US with a resultant greater HTN-related mortality compared to whites Barriers to BP Control in AA exist at 3 levels of care the patient the physician and the healthcare system Using the Chronic Care Model as a framework the investigators seek to test the effect on BP control of a multicomponent multi-level intervention targeted at physicians and patients
DESIGN NARRATIVE
Using the Chronic Care Model as a framework the investigators seek to test the effect on BP control of a multicomponent multi-level intervention targeted at physicians and patients They will conduct a clustered randomized controlled trial in which 30 CMHCs will be randomized to either the intervention or usual care A total of 990 patients with uncontrolled HTN BP greater than 14090 mm Hg will be enrolled for this trial Components of the patient intervention include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN behavioral counseling by trained CMHC dieticians on lifestyle modification and home BP monitoring to activate patients in their own care The physician intervention comprises online continuing medical education CME courses on management of HTN based on the Joint National Committee-7 JNC-7 guidelines online HTN rounds or case conferences with HTN specialists and feedback to physicians on clinical performance measures via computerized decision support systems The intervention will be delivered to patients every 3 months during regular office visits for 12 months while the physician intervention will occur every month for the duration of the trial Patients and physicians at the usual care CMHCs will receive NHLBI patient education materials and print versions of JNC-7 guidelines respectively
The primary outcome is the proportion of patients with adequate BP control at 12 months in each condition as defined by JNC-7 criteria BP less than 13080 mm Hg for patients with diabetes or kidney disease and BP less than 14090 mm Hg for all other patients The secondary outcomes are within-patient change in systolic BP and diastolic BP from baseline to 12 months the maintenance of the intervention effects one year after trial and the cost effectiveness of the intervention at 12 months The long-term goal of this project is to refine the intervention as a result of the data obtained and to develop a standardized protocol that can be integrated into the usual care procedures of the CMHCs Thus maximizing the likelihood that the intervention will be translated into practice at each of the participating Community Health Centers
African Americans AA have the highest prevalence of hypertension HTN in the US with a resultant greater HTN-related mortality compared to whites Barriers to BP Control in AA exist at 3 levels of care the patient the physician and the healthcare system Using the Chronic Care Model as a framework the investigators seek to test the effect on BP control of a multicomponent multi-level intervention targeted at physicians and patients
DESIGN NARRATIVE
Using the Chronic Care Model as a framework the investigators seek to test the effect on BP control of a multicomponent multi-level intervention targeted at physicians and patients They will conduct a clustered randomized controlled trial in which 30 CMHCs will be randomized to either the intervention or usual care A total of 990 patients with uncontrolled HTN BP greater than 14090 mm Hg will be enrolled for this trial Components of the patient intervention include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN behavioral counseling by trained CMHC dieticians on lifestyle modification and home BP monitoring to activate patients in their own care The physician intervention comprises online continuing medical education CME courses on management of HTN based on the Joint National Committee-7 JNC-7 guidelines online HTN rounds or case conferences with HTN specialists and feedback to physicians on clinical performance measures via computerized decision support systems The intervention will be delivered to patients every 3 months during regular office visits for 12 months while the physician intervention will occur every month for the duration of the trial Patients and physicians at the usual care CMHCs will receive NHLBI patient education materials and print versions of JNC-7 guidelines respectively
The primary outcome is the proportion of patients with adequate BP control at 12 months in each condition as defined by JNC-7 criteria BP less than 13080 mm Hg for patients with diabetes or kidney disease and BP less than 14090 mm Hg for all other patients The secondary outcomes are within-patient change in systolic BP and diastolic BP from baseline to 12 months the maintenance of the intervention effects one year after trial and the cost effectiveness of the intervention at 12 months The long-term goal of this project is to refine the intervention as a result of the data obtained and to develop a standardized protocol that can be integrated into the usual care procedures of the CMHCs Thus maximizing the likelihood that the intervention will be translated into practice at each of the participating Community Health Centers
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL078566 | NIH | None | httpsreporternihgovquickSearchR01HL078566 |