NCT00012870

Brief Summary

Nurses play an important role in helping patients to manage symptoms, adhere to treatment, and change behavior. There has been a lack of research regarding nonpharmacologic interventions with patients with heart failure and other chronic conditions.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable heart-failure

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 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Heart Failure

Study Arms (1)

Arm 1

OTHER
Behavioral: Behavioral Management

Interventions

Behavioral ManagementBEHAVIORAL
Arm 1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (3)

  • Shively M, Kodiath M, Smith TL, Kelly A, Bone P, Fetterly L, Gardetto N, Shabetai R, Bozzette S, Dracup K. Effect of behavioral management on quality of life in mild heart failure: a randomized controlled trial. Patient Educ Couns. 2005 Jul;58(1):27-34. doi: 10.1016/j.pec.2004.06.007.

    PMID: 15950833RESULT

  • Shively M, Fox C, Brass-Mynderse NJ. Health-related quality of life as an outcome for patients with heart failure. J Cardiovasc Nurs. 1996 Jan;10(2):89-96. doi: 10.1097/00005082-199601000-00009.

    PMID: 8656241RESULT

  • Kodiath M, Kelly A, Shively M. Improving quality of life in patients with heart failure: an innovative behavioral intervention. J Cardiovasc Nurs. 2005 Jan-Feb;20(1):43-8. doi: 10.1097/00005082-200501000-00009.

    PMID: 15632812RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Martha J. Shively, PhD RN

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

March 1, 2002

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)