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There is a lower recruitment rate than projected.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allied Health Education Class Option | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Exercise - General | Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission Rate | Collected from telephone survey and chart review | 3 months |
| Confidence in Activity Related Decision Making | Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Exercise - General | Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome | Posted | Number | participants | 3 months |
|
6 months following recruitment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Codispodi BMR PT | St. Boniface Hospital | 204-237-2138 | kcodispodi@sbgh.mb.ca |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Physiotherapy treatment intervention on referral | Other | The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription. |
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| Keeping the Beat with Physiotherapy: Heart Failure edition | Device | Educational DVD covering the basics of physiotherapy education for the patient with heart failure. |
|
| 3 months |
| 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. | 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| New York Heart Association (NYHA) Classification | NYHA Classification: Class I: No limitation of physical activity Class II: Slight limitation of physical activity, ordinary physical activity leads to fatigue, palpitation, dyspnea, or anginal pain; comfortable at rest Class III: Marked limitation of physical activity, less-than-ordinary activity results in fatigue, palpitation, dyspnea, or anginal pain; comfortable at rest Class IV: Inability to carry on any physical activity without discomfort but also symptoms of heart failure or the anginal syndrome even at rest, with increased discomfort if any physical activity is undertaken | Number | participants |
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| Working Status | Number | participants |
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| 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. |
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| Secondary | Readmission Rate | Collected from telephone survey and chart review | Posted | Number | participants | 3 months |
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| Secondary | Confidence in Activity Related Decision Making | Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome | Posted | Number | participants | 3 months |
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| 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. | Do you know what to do if weight is changing? | Posted | Number | participants | 3 months |
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| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 12 | 0 | 12 |
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| Somewhat confident |
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| Not at all confident |
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| Unsure |
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