NCT01622010

Brief Summary

The purpose of this research is to determine if there is a greater behaviour change in self management of heart failure following reinforced multimedia education focusing on physical activity as compared to standard care. It is the investigators belief that participants who receive DVD education in addition to usual care will show improved self management in comparison to receiving usual care alone. The investigators anticipate fewer hospital admissions due to improved self care management.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

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

May 22, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

May 22, 2012

Results QC Date

May 3, 2016

Last Update Submit

May 21, 2021

Conditions

Heart Failure

Keywords

Heart FailurePatient Education as TopicPhysical Therapy Specialty

Outcome Measures

Primary Outcomes (1)

  • Frequency of Exercise - General

    Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome

    3 months

Secondary Outcomes (3)

  • Readmission Rate

    3 months

  • Confidence in Activity Related Decision Making

    3 months

  • Confidence in Decision Making Regarding Weight Changes

    3 months

Study Arms (2)

Standard care with video enhancement

EXPERIMENTAL

Receive standard care of an invitation to attend an Allied Health Education Class. May be referred to physiotherapy from Heart Failure Clinic at Physician request per standard clinic protocol. In addition are provided a copy of "Keeping the Beat with Physiotherapy: Heart Failure edition" education DVD related to heart failure, exercise and self management.

Behavioral: Allied Health Education Class OptionOther: Physiotherapy treatment intervention on referralDevice: Keeping the Beat with Physiotherapy: Heart Failure edition

Standard care

ACTIVE COMPARATOR

Receive standard care of an invitation to attend an Allied Health Education Class. May be referred to physiotherapy from Heart Failure Clinic at Physician request per standard clinic protocol.

Behavioral: Allied Health Education Class OptionOther: Physiotherapy treatment intervention on referral

Interventions

Allied Health Education Class OptionBEHAVIORAL

An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.

Standard careStandard care with video enhancement
Physiotherapy treatment intervention on referralOTHER

The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.

Standard careStandard care with video enhancement
Keeping the Beat with Physiotherapy: Heart Failure editionDEVICE

Educational DVD covering the basics of physiotherapy education for the patient with heart failure.

Standard care with video enhancement

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of heart failure
  • Attending Heart Failure Clinic for the first time
  • New York Heart Association Classification - any

You may not qualify if:

  • Inability to understand English or French well enough to participate in a telephone survey
  • Being worked up for transplant, ventricular assist device or other form of cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Kelly Codispodi BMR PT
Organization
St. Boniface Hospital
kcodispodi@sbgh.mb.ca
204-237-2138

Study Officials

  • Kelly Waters, BMR (PT)

    St. Boniface Hospital

    PRINCIPAL INVESTIGATOR

  • Heather J Christie, BMR(PT), MSc

    St. Boniface Hospital

    STUDY CHAIR

  • Jenn Rybuck, BMR(PT)

    St. Boniface Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist, St. Boniface Hospital

Study Record Dates

First Submitted

May 22, 2012

First Posted

June 18, 2012

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 25, 2021

Results First Posted

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)