NCT00012818

Brief Summary

Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

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
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Chronic Heart Failure

Study Arms (1)

Arm 1

OTHER
Behavioral: relaxation techniqueBehavioral: educational program

Interventions

relaxation techniqueBEHAVIORAL
Arm 1
educational programBEHAVIORAL
Arm 1

Eligibility Criteria

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

You may qualify if:

  • CHF diagnosis, NY stage 2 or 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (3)

  • Chang BH, Jones D, Hendricks A, Boehmer U, Locastro JS, Slawsky M. Relaxation response for Veterans Affairs patients with congestive heart failure: results from a qualitative study within a clinical trial. Prev Cardiol. 2004 Spring;7(2):64-70.

    PMID: 15133373RESULT

  • Chang BH, Hendricks A, Zhao Y, Rothendler JA, LoCastro JS, Slawsky MT. A relaxation response randomized trial on patients with chronic heart failure. J Cardiopulm Rehabil. 2005 May-Jun;25(3):149-57. doi: 10.1097/00008483-200505000-00005.

    PMID: 15931018RESULT

  • Chang BH, Hendricks AM, Slawsky MT, Locastro JS. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC Med Res Methodol. 2004 Apr 17;4:8. doi: 10.1186/1471-2288-4-8.

    PMID: 15090073RESULT

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ann M. Hendricks, PhD

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

  • Bei-Hung Chang, ScD

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

September 1, 2003

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)