Heart FailureNCT01622010
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure
A study testing Allied Health Education Class Option, Physiotherapy treatment intervention on referral and Keeping the Beat with Physiotherapy: Heart Failure edition in people with Heart Failure, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Allied Health Education Class Option, Physiotherapy treatment intervention on referral and Keeping the Beat with Physiotherapy: Heart Failure edition
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of heart failure
- Attending Heart Failure Clinic for the first time
- New York Heart Association Classification - any
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of DVD Education on Physical Activity and Self Management of Heart Failure: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Allied Health Education Class Option, Physiotherapy treatment intervention on referral, Keeping the Beat with Physiotherapy: Heart Failure edition
- Keywords
- Heart Failure, Patient Education as Topic, Physical Therapy Specialty
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allied Health Education Class OptionBehavioural
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 referralOther
The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
Keeping the Beat with Physiotherapy: Heart Failure editionDevice
Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Allied Health Education Class Option; Other: Physiotherapy treatment intervention on referral; Device: Keeping the Beat with Physiotherapy: Heart Failure edition |
| 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. Receives: Behavioral: Allied Health Education Class Option; Other: Physiotherapy treatment intervention on referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Exercise - General
Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome
Measured: 3 months
Secondary outcomes (3)
Readmission Rate
Collected from telephone survey and chart review
Measured: 3 months
Confidence in Activity Related Decision Making
Based on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: There is a lower recruitment rate than projected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Waters, University of Manitoba
- Investigators
- Kelly Waters, BMR (PT), Principal investigator, St. Boniface HospitalHeather J Christie, BMR(PT), MSc, Study chair, St. Boniface HospitalJenn Rybuck, BMR(PT), Study chair, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622010
- Sponsor's protocol ID
- H2012:101
- Status last verified
- May 2021
- First submitted
- 22 May 2012
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of DVD Education on Physical Activity and Self Management of Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01622010
- Acronym / sponsor ID
- H2012:101
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Patient Education as Topic, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is a lower recruitment rate than projected.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care with video enhancement | Experimental | Behavioral: Allied Health Education Class Option, Other: Physiotherapy treatment intervention on referral, Device: Keeping the Beat with Physiotherapy: Heart Failure editionReceive 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 | Behavioral: Allied Health Education Class Option, Other: Physiotherapy treatment intervention on referralReceive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of heart failure
- Attending Heart Failure Clinic for the first time
- New York Heart Association Classification - any
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allied Health Education Class OptionAn 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. | Behavioural | Standard care, Standard care with video enhancement |
| Physiotherapy treatment intervention on referralThe option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription. | Other | Standard care, Standard care with video enhancement |
| Keeping the Beat with Physiotherapy: Heart Failure editionEducational DVD covering the basics of physiotherapy education for the patient with heart failure. | Device | Standard care with video enhancement |
Primary outcome
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 secondary outcomes
Readmission Rate
Time frame: 3 months
Confidence in Activity Related Decision Making
Time frame: 3 months
Confidence in Decision Making Regarding Weight Changes
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
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Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Waters, BMR (PT) principal investigator
St. Boniface Hospital
Heather J Christie, BMR(PT), MSc study chair
St. Boniface Hospital
Jenn Rybuck, BMR(PT) study chair
St. Boniface Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allied Health Education Class Option, Physiotherapy treatment intervention on referral and Keeping the Beat with Physiotherapy: Heart Failure edition in people with Heart Failure, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Exercise - General (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.