NCT00299468

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Apr 2006

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 17, 2008

Status Verified

May 1, 2006

Enrollment Period

11 months

First QC Date

March 2, 2006

Last Update Submit

March 12, 2008

Conditions

Keywords

hypertensionhome carepatient activationstages-of-change

Outcome Measures

Primary Outcomes (5)

  • changes in patients' PAM scores

    six months

  • differences in patients' HTN knowledge

    six months

  • adherence to HTN medication and diet recommendations

    six months

  • average changes in patients' systolic and diastolic BP

    six months

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

    six months

Interventions

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10001, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionPatient Participation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Linda M Gerber, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 17, 2008

Record last verified: 2006-05

Locations