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OpenTrials
Completed

NCT Number: NCT00299468

The Effect of the Patient Activation Measure on Chronic Care

We will test - in a chronically ill managed long term care population - the effectiveness of an intervention that provides nurse Care Managers with an inventory of evidence-based practices tailored to patients with different levels of knowledge, skills and confidence to engage in self-care management. Specifically, we will develop a "change package" of evidence-based hypertension (HTN) management strategies geared to patients scoring at the four different stages of activation on the Patient Activation Measure (PAM). We will randomly assign a group of interdisciplinary teams in the managed long-term care plan to intervention or control status and will train the Care Managers on the Intervention teams to use the change package in conjunction with a patient's PAM score to design - with the involvement of the patient - an individualized HTN management plan. We then will assess the impact of the intervention on patient activation and outcomes.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Visiting Nurse Service of New York Center for Home Care Policy & Research

New York, 10001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Activation Measure Intervention Package

Behavioral

Primary outcomes

  1. changes in patients' PAM scores

    Time frame: six months

  2. differences in patients' HTN knowledge

    Time frame: six months

  3. adherence to HTN medication and diet recommendations

    Time frame: six months

  4. average changes in patients' systolic and diastolic BP

    Time frame: six months

  5. percent of patients who maintain BP control, among those with controlled baseline BP

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Visiting Nurse Service of New York

Registry information

Official study title

Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 6, 2006
Registry last updated
Mar 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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