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

This study has been terminated.
(There is a lower recruitment rate than projected. Patients are being screened to participate in another study and with held from our recruitment.)
Sponsor:
Information provided by (Responsible Party):
Kelly Waters, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01622010
First received: May 22, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Allied Health Education Class Option
Other: Physiotherapy treatment intervention on referral
Device: Keeping the Beat with Physiotherapy: Heart Failure edition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of DVD Education on Physical Activity and Self Management of Heart Failure: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Frequency of Exercise - general [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Based on telephone survey responses - ranked Likert scale


Secondary Outcome Measures:
  • Readmission rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Collected from telephone survey and chart review

  • Frequency of exercise - specific [ Time Frame: 2 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    Analysis of exercise log - specific amounts

  • Confidence in activity related decision making [ Time Frame: 2 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    Based on telephone survey responses - ranked Likert scale

  • Confidence in decision making regarding weight changes [ Time Frame: 2 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    Based on telephone survey responses - ranked Likert scale

  • Frequency of Exercise - general [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Based on telephone survey responses - ranked Likert scale


Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard care with video enhancement Behavioral: Allied Health Education Class Option
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.
Other: Physiotherapy treatment intervention on referral
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
Device: Keeping the Beat with Physiotherapy: Heart Failure edition
Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
Active Comparator: Standard care Behavioral: Allied Health Education Class Option
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.
Other: Physiotherapy treatment intervention on referral
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622010

Locations
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
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
  More Information

No publications provided

Responsible Party: Kelly Waters, Senior Physiotherapist, St. Boniface Hospital, University of Manitoba
ClinicalTrials.gov Identifier: NCT01622010     History of Changes
Other Study ID Numbers: H2012:101
Study First Received: May 22, 2012
Last Updated: January 13, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Heart Failure
Patient Education as Topic
Physical Therapy Specialty

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014