Trial Outcomes & Findings for The Effects of DVD Education on Physical Activity and Self Management of Heart Failure (NCT NCT01622010)
NCT ID: NCT01622010
Last Updated: 2021-05-25
Results Overview
Based on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2021-05-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
12
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of DVD Education on Physical Activity and Self Management of Heart Failure
Baseline characteristics by cohort
| Measure |
Standard Care With Video Enhancement
n=18 Participants
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.
|
Standard Care
n=12 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 16.2 • n=99 Participants
|
65.7 Years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
63.9 Years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=99 Participants
|
12 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA class I
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA class II
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA class III
|
9 participants
n=99 Participants
|
3 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA class IV
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Classification
Unclassified
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Working Status
Retired
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Working Status
Disability
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Working Status
Working
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Working Status
Unknown
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsBased on telephone survey responses - ranked Likert scale, 1 - 4 with 1 representing the better outcome
Outcome measures
| Measure |
Standard Care With Video Enhancement
n=17 Participants
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.
|
Standard Care
n=9 Participants
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.
|
|---|---|---|
|
Frequency of Exercise - General
Daily
|
6 participants
|
3 participants
|
|
Frequency of Exercise - General
Few times a week
|
5 participants
|
5 participants
|
|
Frequency of Exercise - General
Few times a month
|
1 participants
|
0 participants
|
|
Frequency of Exercise - General
Not at all
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsCollected from telephone survey and chart review
Outcome measures
| Measure |
Standard Care With Video Enhancement
n=17 Participants
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.
|
Standard Care
n=9 Participants
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.
|
|---|---|---|
|
Readmission Rate
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 monthsBased on telephone survey responses - ranked Likert scale - 1 - 4 with 1 representing better outcome
Outcome measures
| Measure |
Standard Care With Video Enhancement
n=17 Participants
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.
|
Standard Care
n=9 Participants
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.
|
|---|---|---|
|
Confidence in Activity Related Decision Making
Very Confident
|
4 participants
|
2 participants
|
|
Confidence in Activity Related Decision Making
Confident
|
10 participants
|
4 participants
|
|
Confidence in Activity Related Decision Making
Somewhat confident
|
2 participants
|
2 participants
|
|
Confidence in Activity Related Decision Making
Not at all confident
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Do you know what to do if weight is changing?
Based on telephone survey responses - with option of "Yes", "No", "Unsure" where Yes is indicative of a better outcome.
Outcome measures
| Measure |
Standard Care With Video Enhancement
n=17 Participants
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.
|
Standard Care
n=9 Participants
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.
|
|---|---|---|
|
Confidence in Decision Making Regarding Weight Changes
Yes
|
11 participants
|
5 participants
|
|
Confidence in Decision Making Regarding Weight Changes
No
|
3 participants
|
1 participants
|
|
Confidence in Decision Making Regarding Weight Changes
Unsure
|
3 participants
|
3 participants
|
Adverse Events
Standard Care With Video Enhancement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place