Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000390785
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
10/04/2013
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation: A novel approach to the provision of Heart Failure Rehabilitation Programs
Scientific title
To determine the effects of telerehabilitation program on functional capacity, muscle strength, quality of life, balance and falls in people with chronic heart failure, compared with standard heart failure rehabilitation program.
Secondary ID [1] 282232 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic heart failure (CHF) 288746 0
Condition category
Condition code
Cardiovascular 289103 289103 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 289104 289104 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The telerehabilitation intervention will be delivered to participants in their own homes via a computer, broadband internet connection and DVD media. The program design will mirror the conventional heart failure rehabilitation program; comprising of education and exercise sessions. Participants will be able to access the internet twice per week (for 60 minutes each time) over the 12-week duration to guide them through a combined aerobic and strength exercise program. Adherence to the program will be monitored through number of attendance, exercise diary and web cam.
Intervention code [1] 286842 0
Rehabilitation
Comparator / control treatment
Participants in the conventional group will attend a centre-based heart failure rehabilitation program, comprising of education and exercise sessions. Each 12-week program will consist of 60 minutes of aerobic and strength exercise, delivered twice per week. The program is a group-based exercise class delivered by a physiotherapist and a nurse, designed specifically for people with heart failure.
Control group
Active

Outcomes
Primary outcome [1] 289219 0
The six minute walk test (6MWT) is a standardised submaximal measure of exercise capacity frequently used in people with CHF. This is a self-paced walking test on a 30 metre track. Two tests will be performed at baseline and the data from the best test will be used in analysis.
Timepoint [1] 289219 0
baseline, post-program and 3-month follow-up.
Secondary outcome [1] 302065 0
Grip strength for each hand will be measured three times with a hand-held dynamometer. The best measurement of the three tests will be used in the analysis. Similarly, quadriceps muscle strength will be measured three times with a hand-held dynamometer and the best measurement will be used in the analysis.
Timepoint [1] 302065 0
baseline, post-program and 3-month follow-up.
Secondary outcome [2] 302066 0
The Balance Outcome Measure for Elder Rehabilitation (BOOMER) is a clinically applicable measure of standing balance. This tool comprises of the following commonly used balance tests: timed up and go test, functional reach, static balance and step test.
Timepoint [2] 302066 0
baseline, post-program and 3-month follow-up.
Secondary outcome [3] 302067 0
Time taken to walk 10 metres will be recorded. This test will be undertaken at usual and fast pace, and each will be performed twice to reduce a learning effect.
Timepoint [3] 302067 0
This test will be administered at baseline, post-program and at 3-month follow-up visits.
Secondary outcome [4] 302068 0
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLWHFQ). This disease-specific quality of life questionnaire contains 21 questions with scores ranging from 0 to 105, determining the key physical, emotional, social and mental dimensions of quality of life.
Timepoint [4] 302068 0
The MLWHFQ will be provided to patients for completion at baseline, post-program and 3-month follow-up visits.
Secondary outcome [5] 302069 0
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of healthcare.
Timepoint [5] 302069 0
The EQ-5D will be provided to patients for completion at baseline, post-program and 3-month follow-up visits.
Secondary outcome [6] 302070 0
Frequency and severity of urinary incontinence in people with CHF will be measured by the Revised Urinary Incontinence Scale (RUIS).
Timepoint [6] 302070 0
The RUIS will be provided to patients for completion at baseline, post-program and 3-month follow-up sessions.
Secondary outcome [7] 302071 0
The experience of and satisfaction with the telerehabilitation program, will be measured using semi-structured interviews with participants. The Client Satisfaction Questionnaire 8 (CSQ-8) will be adapted to determine the level of satisfaction in the telerehabilitation group compared with the conventional group.
Timepoint [7] 302071 0
Interviews will only be conducted in the telerehabilitation group post-program. CSQ-8 will be administered to both groups post-program.
Secondary outcome [8] 302072 0
A cost analysis of telerehabilitation compared with conventional care will be performed. This consists of direct and indirect costs.
Timepoint [8] 302072 0
post-program.
Secondary outcome [9] 313995 0
Telerehabilitation assessment - Validity data will be established by comparing video-based telerehabilitation assessments with face-to-face assessments, in particular the 6MWT, the timed up and go test and grip strength.
Timepoint [9] 313995 0
Telerehabilitation assessment will be conducted in the telerehabilitation group post-program.
Secondary outcome [10] 313996 0
The system usability scale will also be used to rate a participant’s experience with the telerehabilitation assessment.
Timepoint [10] 313996 0
This survey will be given to the telerehabilitation group post-program, after the telerehabilitation assessment.

Eligibility
Key inclusion criteria
Patients over the age of 18 previously admitted to hospital who:
- Have a primary diagnosis of 'chronic heart failure'.
- Have been started on medical therapy for heart failure.
- Have broadband internet access at home
- Are able to provide signed written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Live in a nursing home or care facility
- Have limited written or verbal English language skills
- Are unable to secure a supervisor for exercise sessions
- Fail to satisfy the safety criteria
- Poor cognition or reduced ability for self care
- Physical limitations that prevent participation in exercise
- Severe hypertrophic obstructive cardiomyopathy
- Any of the exclusion criteria listed by American College of Sport Medicine (ACSM) guidelines 2010 for exercise prescription in a cardiac population.
- Inability or refusal to sign informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with a hospital admission for management of heart failure at The Prince Charles Hospital (Brisbane, Australia) and the Princess Alexandra Hospital (Brisbane, Australia) will be screened by heart failure physiotherapists and invited to participate in the study according to the inclusion and exclusion criteria. Participants, who satisfy the inclusion criteria, provide written informed consent and complete the initial assessment will be randomly allocated to the telerehabilitation or conventional rehabilitation group. Allocation will be concealed through the use of numbered, opaque, sealed envelopes and will be maintained at a central location in order to maintain independence of the randomisation process from project staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A blinded assessor will undertake all pre- and post-program patient outcome measures. Due to the nature of the interventions, neither subject nor treating therapist blinding will be possible.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2013
Actual
25/06/2013
Date of last participant enrolment
Anticipated
Actual
19/06/2015
Date of last data collection
Anticipated
Actual
25/02/2016
Sample size
Target
48
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 822 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 823 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 6647 0
4032 - Chermside
Recruitment postcode(s) [2] 6649 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 287001 0
Hospital
Name [1] 287001 0
Princess Alexandra Hospital Research Foundation and Private Practice Trust Fund
Country [1] 287001 0
Australia
Funding source category [2] 287002 0
Government body
Name [2] 287002 0
Queensland Health Health Practitioner Research Scheme
Country [2] 287002 0
Australia
Funding source category [3] 287006 0
Hospital
Name [3] 287006 0
The Prince Charles Hospital Foundation Grant
Country [3] 287006 0
Australia
Funding source category [4] 291064 0
Charities/Societies/Foundations
Name [4] 291064 0
Health Professional Scholarship, National Heart Foundation of Australia
Country [4] 291064 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road, Chermside, QLD 4032
Country
Australia
Secondary sponsor category [1] 285785 0
Hospital
Name [1] 285785 0
Princess Alexandra Hospital
Address [1] 285785 0
Physiotherapy Department, Ipswich Road, Woolloongabba, QLD 4102
Country [1] 285785 0
Australia
Secondary sponsor category [2] 285786 0
University
Name [2] 285786 0
The University of Queensland
Address [2] 285786 0
Physiotherapy Department, School of Health and Rehabilitation Sciences, St Lucia, QLD 4072
Country [2] 285786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289046 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 289046 0
The Prince Charles Hospital, Metro North Hospital and Health Services, Administration Building, Lower Ground, Rode Road, Chermside QLD 4032
Ethics committee country [1] 289046 0
Australia
Date submitted for ethics approval [1] 289046 0
28/06/2012
Approval date [1] 289046 0
12/07/2012
Ethics approval number [1] 289046 0
HREC/12/QPCH/86

Summary
Brief summary
This randomised controlled trial will evaluate the effectiveness of a 12-week heart failure rehabilitation program that is delivered into the homes of patients via telerehabilitation (Telerehabilitation Group) compared to a 12-week program delivered in the face-to-face manner (Conventional Group).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38738 0
Mr Jared Bruning
Address 38738 0
Physiotherapy Department
The Prince Charles Hospital
Rode Road
Chermside
Brisbane QLD 4032
Country 38738 0
Australia
Phone 38738 0
+61 7 3139 4443
Fax 38738 0
+61 7 3139 4082
Email 38738 0
[email protected] .gov.au
Contact person for public queries
Name 38739 0
Mr Jared Bruning
Address 38739 0
Physiotherapy Department
The Prince Charles Hospital
Rode Road
Chermside
Brisbane QLD 4032
Country 38739 0
Australia
Phone 38739 0
+61 7 3139 4443
Fax 38739 0
+61 7 3139 4082
Email 38739 0
[email protected] .gov.au
Contact person for scientific queries
Name 38740 0
Ms Rita Hwang
Address 38740 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38740 0
Australia
Phone 38740 0
+61 7 3176 2111 pager 1415
Fax 38740 0
+61 7 3176 6495
Email 38740 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
EmbaseExploring patient experiences and perspectives of a heart failure telerehabilitation program: A mixed methods approach.2017https://dx.doi.org/10.1016/j.hrtlng.2017.03.004
N.B. These documents automatically identified may not have been verified by the study sponsor.