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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01622010
Enrollment
30
Registered
2012-06-18
Start date
2013-04-30
Completion date
2014-07-31
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Patient Education as Topic, Physical Therapy Specialty

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.

Interventions

BEHAVIORALAllied 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.

OTHERPhysiotherapy treatment intervention on referral

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

DEVICEKeeping the Beat with Physiotherapy: Heart Failure edition

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

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Exercise - General3 monthsBased on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome

Secondary

MeasureTime frameDescription
Readmission Rate3 monthsCollected from telephone survey and chart review
Confidence in Activity Related Decision Making3 monthsBased on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
Confidence in Decision Making Regarding Weight Changes3 monthsBased on telephone survey responses - with option of Yes, No, Unsure where Yes is indicative of a better outcome.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Standard Care With Video Enhancement
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. Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription. Keeping the Beat with Physiotherapy: Heart Failure edition: Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
18
Standard Care
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. Physiotherapy treatment intervention on referral: The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
12
Total30

Baseline characteristics

CharacteristicStandard Care With Video EnhancementStandard CareTotal
Age, Continuous62.7 Years
STANDARD_DEVIATION 16.2
65.7 Years
STANDARD_DEVIATION 7
63.9 Years
STANDARD_DEVIATION 13.2
New York Heart Association (NYHA) Classification
NYHA class I
4 participants4 participants8 participants
New York Heart Association (NYHA) Classification
NYHA class II
4 participants4 participants8 participants
New York Heart Association (NYHA) Classification
NYHA class III
9 participants3 participants12 participants
New York Heart Association (NYHA) Classification
NYHA class IV
0 participants0 participants0 participants
New York Heart Association (NYHA) Classification
Unclassified
1 participants1 participants2 participants
Region of Enrollment
Canada
18 participants12 participants30 participants
Sex: Female, Male
Female
3 Participants0 Participants3 Participants
Sex: Female, Male
Male
15 Participants12 Participants27 Participants
Working Status
Disability
1 participants0 participants1 participants
Working Status
Retired
6 participants3 participants9 participants
Working Status
Unknown
6 participants7 participants13 participants
Working Status
Working
5 participants2 participants7 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 180 / 12
serious
Total, serious adverse events
0 / 180 / 12

Outcome results

Primary

Frequency of Exercise - General

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

Time frame: 3 months

ArmMeasureGroupValue (NUMBER)
Standard Care With Video EnhancementFrequency of Exercise - GeneralDaily6 participants
Standard Care With Video EnhancementFrequency of Exercise - GeneralFew times a week5 participants
Standard Care With Video EnhancementFrequency of Exercise - GeneralFew times a month1 participants
Standard Care With Video EnhancementFrequency of Exercise - GeneralNot at all5 participants
Standard CareFrequency of Exercise - GeneralNot at all1 participants
Standard CareFrequency of Exercise - GeneralDaily3 participants
Standard CareFrequency of Exercise - GeneralFew times a month0 participants
Standard CareFrequency of Exercise - GeneralFew times a week5 participants
p-value: 0.487Chi-squared
Secondary

Confidence in Activity Related Decision Making

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

Time frame: 3 months

ArmMeasureGroupValue (NUMBER)
Standard Care With Video EnhancementConfidence in Activity Related Decision MakingVery Confident4 participants
Standard Care With Video EnhancementConfidence in Activity Related Decision MakingConfident10 participants
Standard Care With Video EnhancementConfidence in Activity Related Decision MakingSomewhat confident2 participants
Standard Care With Video EnhancementConfidence in Activity Related Decision MakingNot at all confident1 participants
Standard CareConfidence in Activity Related Decision MakingNot at all confident1 participants
Standard CareConfidence in Activity Related Decision MakingVery Confident2 participants
Standard CareConfidence in Activity Related Decision MakingSomewhat confident2 participants
Standard CareConfidence in Activity Related Decision MakingConfident4 participants
Comparison: Null hypothesis: Standard care is better than standard care with video enhancement.p-value: 0.628Fisher Exact
Secondary

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.

Time frame: 3 months

Population: Do you know what to do if weight is changing?

ArmMeasureGroupValue (NUMBER)
Standard Care With Video EnhancementConfidence in Decision Making Regarding Weight ChangesYes11 participants
Standard Care With Video EnhancementConfidence in Decision Making Regarding Weight ChangesNo3 participants
Standard Care With Video EnhancementConfidence in Decision Making Regarding Weight ChangesUnsure3 participants
Standard CareConfidence in Decision Making Regarding Weight ChangesYes5 participants
Standard CareConfidence in Decision Making Regarding Weight ChangesNo1 participants
Standard CareConfidence in Decision Making Regarding Weight ChangesUnsure3 participants
p-value: 0.647Chi-squared
Secondary

Readmission Rate

Collected from telephone survey and chart review

Time frame: 3 months

ArmMeasureValue (NUMBER)
Standard Care With Video EnhancementReadmission Rate7 participants
Standard CareReadmission Rate4 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026