NCT00309764

Brief Summary

The overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (CHF) patients by integrating a readily available, low cost technology - the telephone - into coordinated CHF care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2001

Shorter than P25 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

Study Start

First participant enrolled

November 1, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

April 3, 2006

Status Verified

March 1, 2006

First QC Date

March 31, 2006

Last Update Submit

March 31, 2006

Conditions

Congestive Heart Failure (CHF)

Outcome Measures

Primary Outcomes (3)

  • Change between study entry and exit (6-months later) in frequency of recommended CHF self-care practices (maintain CHF diary, check weight daily, check ankles and feet for swelling daily)

  • Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)

  • Quality of life

Secondary Outcomes (1)

  • Rate of acute CHF exacerbations (ED visits or hospital admissions for CHF or CHF-related conditions) in the 6-month intervention period compared with the 6-month period preceding study entry.

Interventions

TelemedicineBEHAVIORAL

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosed CHF
  • Member of Kaiser Permanente Georgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente - Georgia

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Douglas Roblin, PhD

    Kaiser Permanente - Georgia Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

November 1, 2001

Study Completion

August 1, 2002

Last Updated

April 3, 2006

Record last verified: 2006-03

Locations

US(1)