- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299468
The Effect of the Patient Activation Measure on Chronic Care
Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The three main aims of the project are to:
- Determine whether the PAM-driven intervention increases patients' knowledge and self-management skills, measured by both generic PAM scores and HTN-specific measures developed by the research team.
Determine whether the PAM-driven intervention improves HTN patients' systolic and diastolic blood pressure (BP), measured in three ways:
- Average percent reduction in systolic and diastolic BP.
- Percent of patients who achieve BP control (defined as <140 systolic and <90 diastolic BP or <130 systolic and <80 diastolic for patients with diabetes or renal disease).
- Percent of patients with controlled HTN who maintain control.
Conduct an analysis to examine implementation of the intervention by trainers and Care Managers in the Intervention group and to understand the barriers and facilitators affecting the implementation process.
In addition, we will conduct a feasibility study with a subset of Care Managers to determine how the Visual Scan Assessment of Patient Activation might be incorporated into routine assessment and care planning procedures. Therefore, the fourth aim of the project is to:
- Assess the feasibility and perceived usefulness of the Visual Scan Assessment as a tool to increase feedback to Care Managers on how well they are supporting patient self-care management.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10001
- Visiting Nurse Service of New York Center for Home Care Policy & Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- active VNS CHOICE patient on one of the 22 Intervention or Control teams at the start of the intervention period,
- in care for less than or equal to 730 days,
- a formal diagnosis of HTN (using appropriate ICD codes recorded in the patient record), and
- English speaking.
Exclusion Criteria:
- moderate or severe cognitive impairment as measured by a six-item short portable mental status assessment
- organic brain disease dx in as one of the top 5 dx as measured by information in OASIS, the uniform home care assessment instrument mandated by the Centers for Medicare and Medicaid Services
- End Stage Renal disease dx as one of the top 5 dx as measured by information in OASIS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in patients' PAM scores
Time Frame: six months
|
six months
|
differences in patients' HTN knowledge
Time Frame: six months
|
six months
|
adherence to HTN medication and diet recommendations
Time Frame: six months
|
six months
|
average changes in patients' systolic and diastolic BP
Time Frame: six months
|
six months
|
percent of patients who maintain BP control, among those with controlled baseline BP
Time Frame: six months
|
six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Linda M Gerber, Ph.D., Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 290-00-0013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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