NCT00526773

Brief Summary

To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (HF) disease management program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

September 5, 2007

Last Update Submit

October 11, 2010

Conditions

Heart Failure

Keywords

motivational therapy

Outcome Measures

Primary Outcomes (1)

  • To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in HF disease management.

    12 weeks

Study Arms (2)

1

OTHER

Telephone management plus a motivational intervention

Other: telephone management plus a motivational intervention

2

OTHER

Telephone management with standard patient education

Other: telephone management with standard patient education

Interventions

telephone management plus a motivational interventionOTHER

heart failure intervention

1
telephone management with standard patient educationOTHER

heart failure intervention

2

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English

You may not qualify if:

  • Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Barbara Reigel, DNSc, RN, CS, FAAN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 10, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

US(1)