- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622010
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure: A Randomized Controlled Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard care with video enhancement
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.
|
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.
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
|
|
Active Comparator: Standard care
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.
|
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.
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Exercise - General
Time Frame: 3 months
|
Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readmission Rate
Time Frame: 3 months
|
Collected from telephone survey and chart review
|
3 months
|
|
Confidence in Activity Related Decision Making
Time Frame: 3 months
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Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
|
3 months
|
|
Confidence in Decision Making Regarding Weight Changes
Time Frame: 3 months
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Based on telephone survey responses - with option of "Yes", "No", "Unsure" where Yes is indicative of a better outcome.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kelly Waters, BMR (PT), St. Boniface Hospital
- Study Chair: Heather J Christie, BMR(PT), MSc, St. Boniface Hospital
- Study Chair: Jenn Rybuck, BMR(PT), St. Boniface Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2012:101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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