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The Effects of DVD Education on Physical Activity and Self Management of Heart Failure

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Allied Health Education Class Option
Physiotherapy treatment intervention on referral
Keeping the Beat with Physiotherapy: Heart Failure edition
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Patient Education as Topic, Physical Therapy Specialty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard care with video enhancement

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Readmission Rate
Collected from telephone survey and chart review
Confidence in Activity Related Decision Making
Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
Confidence in Decision Making Regarding Weight Changes
Based on telephone survey responses - with option of "Yes", "No", "Unsure" where Yes is indicative of a better outcome.

Full Information

First Posted
May 22, 2012
Last Updated
May 21, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01622010
Brief Title
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure
Official Title
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
There is a lower recruitment rate than projected.
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
With an aging population, heart failure is becoming more common and there is an increasing role for physiotherapy involvement with these patients. The Heart Failure Clinic is conducted by a heart failure physician, cardiac nurse, and a pharmacist. Occupational and Physical Therapists are available on a consult basis. The Clinic has expanded quickly from 49 new patients in 2004 - 2005 to 435 new patients in 2010 - 2011. Due to space and time constraints in the clinic an Allied Heath Education Class was created to provide an interactive multidisciplinary education session. All new patients, regardless of their NYHA classification, and their families are invited to attend the class. Speakers include a Physiotherapist, Occupational Therapist, Dietician and Pharmacist. There is a didactic section followed by discussion after each of the speakers. Few studies have focused on physical activity as one of the major self management strategies for heart failure. There is little understanding by patients about how physical activity can improve symptoms of heart failure over time in conjunction with other lifestyle modifications. Physiotherapists have the skills to provide this education and develop individual exercise programs. Patients are currently provided with verbal and written educational material regarding a diagnosis of heart failure, physical activity, diet and medication. Previous experience with patients following acute cardiac events, either medical or surgical, has shown that providing patients with a DVD which reinforced inpatient education was successful in bridging the gap between inpatient and outpatient rehabilitation programs. Patients were able to review the education provided in their own time. Therefore, a DVD was developed which focused on typical education provided to the heart failure patient by the physiotherapist. We will compare two randomly assigned groups. The first will receive standard education received in heart failure clinic and an optional Allied Health Education Class plus a copy of the Keeping the Beat with Physiotherapy: Heart Failure edition DVD. The second group will receive the standard education provided through the heart failure clinic and the optional education class. Participants will be followed up three times over a six month period via telephone. The survey questions require a simple yes/no answer or are of a likert-style. After each telephone survey participants, will be asked to mail in their exercise and weight logs. Chart reviews will also be conducted for the collection of readmission rates and the number of clinical visits occurring during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Patient Education as Topic, Physical Therapy Specialty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care with video enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Allied Health Education Class Option
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy treatment intervention on referral
Intervention Description
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
Intervention Type
Device
Intervention Name(s)
Keeping the Beat with Physiotherapy: Heart Failure edition
Intervention Description
Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
Primary Outcome Measure Information:
Title
Frequency of Exercise - General
Description
Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Readmission Rate
Description
Collected from telephone survey and chart review
Time Frame
3 months
Title
Confidence in Activity Related Decision Making
Description
Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
Time Frame
3 months
Title
Confidence in Decision Making Regarding Weight Changes
Description
Based on telephone survey responses - with option of "Yes", "No", "Unsure" where Yes is indicative of a better outcome.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of heart failure Attending Heart Failure Clinic for the first time New York Heart Association Classification - any Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Waters, BMR (PT)
Organizational Affiliation
St. Boniface Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather J Christie, BMR(PT), MSc
Organizational Affiliation
St. Boniface Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jenn Rybuck, BMR(PT)
Organizational Affiliation
St. Boniface Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of DVD Education on Physical Activity and Self Management of Heart Failure

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