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Trial registered on ANZCTR


Registration number
ACTRN12615000398505
Ethics application status
Approved
Date submitted
26/03/2015
Date registered
29/04/2015
Date last updated
29/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of nurse-supported telehealth for people with heart conditions
Scientific title
A randomised controlled trial of nurse-supported telehealth for chronic heart failure (CHF) management
Secondary ID [1] 286422 0
nil known
Universal Trial Number (UTN)
U1111-1168-7620
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 294590 0
Self-care behaviour 294591 0
Condition category
Condition code
Cardiovascular 294890 294890 0 0
Other cardiovascular diseases
Public Health 294891 294891 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a novel 6 months telehealth intervention to complement community-based, nurse-support for CHF management. Central to this process will be the utilisation of Medtech 32, a modular practice management software. Medtech has a secure internet health portal (VitelMed) that enables individuals to upload daily clinical information, to allow them to engage electronically with the nurse to support self-management and more focussed patient care. The study’s nurse will review patients’ online records on a weekly basis and alerts will be set up on the system to highlight when a patient’s data suggests clinical changes and the requirement for the patient to seek medical advice. Patients without internet access will not be excluded from the study. They will be able to engage a family member to upload their clinical information, or will be provided with a diary to record clinical information that can be posted to the study’s Project Officer who will upload information on their behalf.
To support the telehealth intervention participants will receive CHF education and have a telehealth heart failure management plan developed during an initial face to face appointment (2 hours) with the project’s CHF nurse. If a face to face appointment is not possible a telephone conference will be arranged. Participants will be provided with a computer tablet and three devices that monitor their health; scales, a blood pressure monitor and physical activity monitor and will be orientated to this equipment and software at the initial appointment. These devices stream data automatically to the computer tablet which then gets uploaded to VitelMed, so that it can be accessed remotely by the study’s nurse. Participants will be phoned once a week (15 minutes) for the first month to provide support for ongoing self-management and using the telehealth devices. Participants’ will also enter their self-management observations into the self-management database through a secure online portal for ongoing review by the project’s nurse. The nurse will undertake surveillance of participant’s recorded details and use these to guide self-management and link the participant to their GP/Cardiologist in the event of clinical deterioration.
Intervention code [1] 291498 0
Treatment: Other
Comparator / control treatment
Patients will receive usual medical care from their GP, literature about CHF self-management in line with local protocols for the 6 month trial, but no telehealth support.
Control group
Active

Outcomes
Primary outcome [1] 294646 0
self-care behaviour is assessed using Self-Care of Heart Failure Index (SCHFI)
Timepoint [1] 294646 0
Baseline before intervention and at 6 months (post-intervention)
Primary outcome [2] 294647 0
Quality of life is assessed using Minesotta Living with Heart Faillure Questionnaire and Short Form 12
Timepoint [2] 294647 0
6 months post randomisation
Primary outcome [3] 294648 0
Clinical Outcomes through access to Department of Health records held by the Data Linkage Unit (mortality and readmissions).
Timepoint [3] 294648 0
6 months post randomisation
Secondary outcome [1] 313792 0
Perceptions of nurse-supported telehealth amongst patients with CHF through Nurse-supported telehealth for people with heart conditions questionnaire which is designed specifically for this study
Timepoint [1] 313792 0
6 months post-intervention
Secondary outcome [2] 314165 0
Cost effectiveness will involve three tasks:
1. Measuring and valuing the health system costs of implementing each intervention.
2. Measuring and valuing the health system and associated costs of treating patients in each arm of the study for the 6-month study period following hospital discharge.
3. Calculating the total costs of each arm of the study
Timepoint [2] 314165 0
6 months post intervention

Eligibility
Key inclusion criteria
prior hospital admission with a primary or secondary diagnosis of CHF
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lack of fluency in English
2. Unable to give informed consent
3. Terminal illness such as metastatic cancer or severe hepatic/renal failure, significant cognitive impairment or physical inability to engage in self-care behaviours
4. Patients with severe end-stage CHF who are receiving palliative therapy

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)
The sample will be drawn from patients who are treated at three Western Australia public hospitals; Royal Perth Hospital (RPH), Fiona Stanley Hospital (FSH) and Sir Charles Gairdner Hospital (SCGH). These patients will be identified from ICD-10 codes describing a primary or secondary diagnosis of CHF and will be randomized to either the intervention or control group. Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the baseline variables, summary statistics will be constructed employing frequencies and proportions for categorical data and means and standard deviation for continuous variables. The participant characteristics will be compared using Fisher’s exact test for categorical outcomes and t tests for continuous variables. The primary endpoint of a composite of all cause death and rehospitalisation for worsening CHF will be analysed using the stratified log-rank test for eligible patients with age (greater than or equal to 65 vs <65 years), LVEF (greater than or equal to 30% vs <30%) and history of ischaemic heart disease (IHD vs non-IHD) as stratification factors. Time to events will be estimated using Kaplan-Meier curves, and hazard ratios and 95% confidence intervals will be calculated using the Cox proportional hazards models with stratification factors. Sensitivity analyses will also be performed by means of the unadjusted Cox models. P < 0.05 will be considered statistically significant.

Based on the result of previous studies we estimate that the hazard ratio of the primary endpoint (all-cause death and hospitalisation for worsening CHF) of the telehealth group to the control group would be 0.60 and that the cumulative annual event rate in the usual care group would be 0.30. Based on 80% power to detect a 40% relative reduction in the risk of the primary outcome in the intervention group at 6 months, compared with the control group, and an expected death rate at 6 months of 30% in the control group using a log-rank test with a two-sided a of 0.05 we plan to plan to recruit a total sample size of 240 patients (120 in each group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3610 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 3611 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 3612 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 290993 0
Government body
Name [1] 290993 0
Department of Health, Western Australia
Country [1] 290993 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Andrew Maiorana
Address
School of Physiotherapy and Exercise Science
Faculty of Health Sciences
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 289673 0
None
Name [1] 289673 0
Address [1] 289673 0
Country [1] 289673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292581 0
HREC Curtin University
Ethics committee address [1] 292581 0
Ethics committee country [1] 292581 0
Australia
Date submitted for ethics approval [1] 292581 0
Approval date [1] 292581 0
10/09/2014
Ethics approval number [1] 292581 0
HR 181/2014

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

Contacts
Principal investigator
Name 56074 0
Miss Sheau Huey Chen (Nicole)
Address 56074 0
School of Physiotherapy and Exercise Science
Faculty of Health Sciences
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country 56074 0
Australia
Phone 56074 0
(+614) 30161252
Fax 56074 0
Email 56074 0
sheauhuey.chen@postgrad.curtin.edu.au
Contact person for public queries
Name 56075 0
Andrew Maiorana
Address 56075 0
School of Physiotherapy and Exercise Science
Faculty of Health Sciences
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country 56075 0
Australia
Phone 56075 0
(+618) 9266 9225
Fax 56075 0
Email 56075 0
A.Maiorana@curtin.edu.au
Contact person for scientific queries
Name 56076 0
Andrew Maiorana
Address 56076 0
School of Physiotherapy and Exercise Science
Faculty of Health Sciences
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country 56076 0
Australia
Phone 56076 0
(+618) 9266 9225
Fax 56076 0
Email 56076 0
A.Maiorana@curtin.edu.au

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
No additional documents have been identified.