Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000437268
Ethics application status
Approved
Date submitted
18/02/2009
Date registered
11/06/2009
Date last updated
11/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a self-paced intervention to increase distance walked and decrease admissions to hospital in people with heart failure
Scientific title
Evaluation of a modified, self-administered six minute walk test to improve health related outcomes in people with symptomatic heart failure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 4338 0
Condition category
Condition code
Cardiovascular 4594 4594 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo baseline assessment including a standardised six munite walk test, heart rate assessment, blood pressure measurement and questionnaires to assess functional status and self-efficacy. All participants will receive an information session from a cardiac nurse identifying the importance of self-management. They will also be given an action plan and the National Heart Foundation Consumer Resource Guide, which are part of the routine care provided by the Area Health Service. Both the intervention and control groups will receive monthly telephone follow-up for six months. Participants in the intervention group will undertake The Home-Heart-Walk program. This is a self-administered, modified six minute walkexercise activity. Participants will be instructed to undertake the Home-Heart-Walk at least weekly for six months at their own home, using the provided "home kit", that includes a 5-metres long rope, a digital count down timer, a lap counter and a study diary.
To undertake the Home-Heart-Walk participants will be instructed to walk alongside the 5-metre rope (marked in 1-metre gradations with the numbers “0-5”) on a flat, hard surface, free of obstacles while trying to cover as much distance as possible in 6 minutes. Stopping and resting will be allowed during the walk. Encouragement will not be used during the walk. Participants will also use the lap counter to count how many full laps they have walked. At the end of the 6 minutes, participants will be asked to record how many full laps they have walked, and at which number they stopped at the end of the walk. This is to allow calculation of the distance walked during the 6 minutes.
Intervention code [1] 4070 0
Rehabilitation
Intervention code [2] 4071 0
Prevention
Intervention code [3] 4072 0
Early detection / Screening
Comparator / control treatment
Control group: standard heart failure management and monthly telephone follow-up for six months (regarding self-management in the context of participant's condition) standard heart failure management from Area Health Service includes home visits and telephone follow-up. The frequency and length of home visits and telephone follow-up is determined by individual’s clinical needs.
Participants from both groups will undertake baseline assessment, including the six-minute walk Test and receive an information session from a cardiac nurse identifying the importance of self-management. They will also be given an action plan and the National Heart Foundation Consumer Resource Guide, which are part of the routine care provided by the Area Health Service..
Control group
Active

Outcomes
Primary outcome [1] 5470 0
Patient perceived health related quality of life measured by the Medical Outcomes Study Short Form 36
Timepoint [1] 5470 0
Baseline, 3 months and 6 months
Secondary outcome [1] 9179 0
Distance walked on a standard 6 minute walk test
Timepoint [1] 9179 0
Baseline, 3 months, 6 months
Secondary outcome [2] 9180 0
Enropean Heart Failure self-care Behaviour Scale
Timepoint [2] 9180 0
Baseline, 3 months, 6 months
Secondary outcome [3] 9181 0
Physical activity level measured by the National Physical Activity Prescription Scale which is a self-administered test
Timepoint [3] 9181 0
Baseline, 3 months, 6 months
Secondary outcome [4] 9182 0
Bandura's Exercise Self-efficacy Scale
Timepoint [4] 9182 0
Baseline, 3 months, 6 months
Secondary outcome [5] 9183 0
The Minnesota Living with Heart Failure Questionnaire will assess the impact of heart failure on health related quality of life.
Timepoint [5] 9183 0
Baseline, 3 months, 6 months
Secondary outcome [6] 241761 0
Major acute cardiovascular events (MACE) includes death, non-fatal acute myocardial infarction and acute coronary syndrome events as well as planned and unplanned revascularisation.
Timepoint [6] 241761 0
3 month and 6 month follow up
Secondary outcome [7] 241762 0
All cause hospitalisation
Timepoint [7] 241762 0
3 and 6 month follow-up

Eligibility
Key inclusion criteria
Hospitalised for heart failure within the previous 6 months.
New York Heart Association-Functional Calss II or III
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable angina pectoris.
Recent unexplained syncope.
Failure to give informed consent.
Resting heart rate greater than 120.
Inability to perform the six minute walk test (6MWT) (e.g. severe arthritis)
Significant cognitive impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research personnel will fax the newly recurited participant's name and date of birth, from the recuritement site, to an administrative officer at the Centre for Cardiovascular and Chronic Care, for randomisation.These codes will be stored securely in the Centre for Cardiovascular and Chronic Care and accessible by an office manager who is not involved in conduct of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
166
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1511 0
2010
Recruitment postcode(s) [2] 1512 0
2770
Recruitment postcode(s) [3] 1513 0
2148

Funding & Sponsors
Funding source category [1] 4531 0
Government body
Name [1] 4531 0
Department of Health and Ageing
Country [1] 4531 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
39 Regent Street
Chippendale
NSW 2008
Country
Australia
Secondary sponsor category [1] 4357 0
Hospital
Name [1] 4357 0
St Vincents Hospital
Address [1] 4357 0
Victoria Street Darlinghurst NSW 2010
Country [1] 4357 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6583 0
St Vincent's Hospital
Ethics committee address [1] 6583 0
Ethics committee country [1] 6583 0
Australia
Date submitted for ethics approval [1] 6583 0
Approval date [1] 6583 0
24/09/2008
Ethics approval number [1] 6583 0
1/08/0077

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29296 0
Address 29296 0
Country 29296 0
Phone 29296 0
Fax 29296 0
Email 29296 0
Contact person for public queries
Name 12543 0
Professor Patricia Davidson
Address 12543 0
Centre for Cardiovascular and Chronic Care, Curtin University
39 Regent Street,
Chippendate,
NSW 2008
Country 12543 0
Australia
Phone 12543 0
+61 2 83997831
Fax 12543 0
+61 2 83997834
Email 12543 0
[email protected]
Contact person for scientific queries
Name 3471 0
Professor Patricia Davidson
Address 3471 0
Centre for Cardiovascular and Chronic Care, Curtin University
39 Regent Street,
Chippendate,
NSW 2008
Country 3471 0
Australia
Phone 3471 0
+61 2 83997831
Fax 3471 0
+61 2 83997834
Email 3471 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Home-Heart-Walk study, a self-administered walk test on perceived physical functioning, and self-care behaviour in people with stable chronic heart failure: A randomized controlled trial.2018https://dx.doi.org/10.1177/1474515117729779
N.B. These documents automatically identified may not have been verified by the study sponsor.