NCT00371085

Brief Summary

Heart failure is a very common condition and is one of the main reasons people are admitted to hospital. There are many things people with heart failure can do to manage their condition at home. Unfortunately many people do not have enough information to do this and need to come back to the hospital because their heart failure got worse. This study will look at different ways to help people learn more about heart failure and how to manage their condition at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
539

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_4 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

Study Start

First participant enrolled

October 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

6.2 years

First QC Date

August 30, 2006

Last Update Submit

September 22, 2011

Conditions

Keywords

heart failurequality improvementpatient educationhealth care economics

Outcome Measures

Primary Outcomes (1)

  • Differences in clinical outcomes, as measured by cardiovascular hospitalizations and emergency room presentations, between video-based education and usual care groups.

    6 months

Secondary Outcomes (4)

  • Differences in all-cause hospitalizations between groups

    6 months

  • Differences in CHF-related hospitalizations between groups

    6 months

  • Differences in total number of in-hospital days between groups

    6 months

  • Change in CHF knowledge levels from the initial in-hospital patient contact to the end of the 6 month follow-up between the two groups

    6 months

Study Arms (1)

1

EXPERIMENTAL

Video-based patient education on heart failure self care

Behavioral: education

Interventions

educationBEHAVIORAL

Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction

1

Eligibility Criteria

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

You may qualify if:

  • patient in hospital or emergency room with symptomatic CHF confirmed by a physician.
  • patient seen in an outpatient clinic with symptomatic CHF confirmed by a physician, AND hospitalized within the previous 6 months for heart failure.
  • age greater than 18 years.

You may not qualify if:

  • asymptomatic CHF
  • life expectancy \< 6 months
  • receiving chronic hemodialysis or peritoneal dialysis
  • unable to communicate (non-English speaking, intubated, etc)
  • demented or a mental illness which precludes participation
  • receives professional assistance for self-care activities including meals or medications (e.g. nursing home)
  • previously enrolled in this study
  • participation in another heart failure study, or
  • declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital & others in Canada (contact PI)

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ross T Tsuyuki, Pharm D, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 23, 2011

Record last verified: 2011-09

Locations