Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000069459
Ethics application status
Approved
Date submitted
17/01/2007
Date registered
22/01/2007
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care: The WHICH? Study
Scientific title
A multicentre, randomised trial of home-based versus clinic-based, nurse-led, multidisciplinary management of chronic heart failure: The Which Intervention is most Cost effective and consumer friendy in reducing Hospital care in heart failure (WHICH?) Trial
Secondary ID [1] 253425 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The WHICH? Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with chronic heart failure 1561 0
Condition category
Condition code
Cardiovascular 1660 1660 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups are interventional and will be enrolled either into a homebased program or clinical based program. It is a comparative study of home-based management program versus clinic based intervention program. Participants will have a total of four visits. Each visit will consist of an interview and completion of quality of life questionnaires. It is anticipated that each visit will be 1 hour to 1 1/2 hours. Each patient will have access to a core team of heart failure specialists including cardiologist, pharmacist and CHF nurse. These visit will be at recruitment and six-monthly intervals up to a maximum of 18 months.
Intervention code [1] 1551 0
Other interventions
Comparator / control treatment
Clinical based program
Control group
Active

Outcomes
Primary outcome [1] 2299 0
Cost of healthcare
Timepoint [1] 2299 0
At completion of trial
Primary outcome [2] 2300 0
Mortality/morbidity
Timepoint [2] 2300 0
Six monthly intervals during the study for 18 months.
Primary outcome [3] 290258 0
The composite primary outcome was event-free survival from all-cause death or hospitalisation (dichotomous variable) and related days alive and out-of-hospital.

All health outcome data were collected from the date of discharge to home from the index hospitalization. Outcome data were initially collected to March 31st 2011 using standardized methods of data extraction from hospital records. Thereafter, the same methods were used to collected data (extended follow-up to March 31st 2013) on all-cause mortality and hospitalization and related hospital stay.
Timepoint [3] 290258 0
Census of outcome data on March 31st 2013 (up to 5 years post index hospitalisation). Detailed primary outcome data assesed at the end of the 5 years extended follow-up.
Secondary outcome [1] 4008 0
Standard of heart failure care
Timepoint [1] 4008 0
At recruitment and six monthly intervals for 18 months.
Secondary outcome [2] 4009 0
Patient and carer quality of life
Timepoint [2] 4009 0
At recruitment and six monthly intervals for 18 months.

Eligibility
Key inclusion criteria
Patients aged equal to or greater than 18 years who were discharged to home were eligible to participate if they had a diagnosis of CHF, as confirmed by a cardiologist and consistent with Australian guidelines 23) with persistent moderate to severe symptoms (NYHA II-III), and a recent history of at least one admission for acute heart failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They were excluded if they lived outside a 30km radius of the participating hospital, had a terminal condition (other than CHF) that was likely to result in death or hospitalisation within 12 months, were non-English speaking and/or unable to give fully informed consent (e.g. due to significant cognitive impairment).

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 admitted with Chronic Heart Failure are eligible for recruitment. Sealed opaque envelopes that will be performed off-site at the Baker Institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
We estimated this study would have 80% power (two-sided alpha of 0.05) to detect a 15% absolute difference in the primary end-point in addition to a 15% variation in the rate of all-cause hospital stay (in days) with 280 randomized patients.

Univariate comparisons of baseline data involved Chi square analyses (with calculation of odds ratios [OR] and 95% confidence intervals [CI’s] for categorical data, Mann Whitney U test for non-normally distributed continuous data (including the rate of hospital stay and health care costs) and Student’s t-test for normally distributed continuous data. All-cause mortality and event-free survival data were initially analyzed using Kaplan Meier survival curves. Days alive out-of-hospital were calculated as days of survival free from unplanned and all-cause hospitalization. Health care costs are calculated per patient per day. All costs are expressed in 2009/10 Australian dollars (AU$1.00 ˜ US$1.00). Backward, step-wise multiple logistic regression and Cox proportional hazards models (including baseline demographic and clinical profile data) were constructed to examine the independent impact of group allocation on: i) presence in the upper quartile group for most days of re-hospitalization, ii) event-free survival and iii) all-cause mortality.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
15/05/2008
Date of last participant enrolment
Anticipated
Actual
26/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 1807 0
Government body
Name [1] 1807 0
National Health and Medical Research Council
Country [1] 1807 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 1627 0
None
Name [1] 1627 0
Nil
Address [1] 1627 0
Country [1] 1627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3381 0
Alfred Hospital
Ethics committee address [1] 3381 0
Ethics committee country [1] 3381 0
Australia
Date submitted for ethics approval [1] 3381 0
Approval date [1] 3381 0
26/06/2007
Ethics approval number [1] 3381 0
26/07
Ethics committee name [2] 3382 0
Princess Alexandra hospital
Ethics committee address [2] 3382 0
Ethics committee country [2] 3382 0
Australia
Date submitted for ethics approval [2] 3382 0
Approval date [2] 3382 0
22/05/2007
Ethics approval number [2] 3382 0
2007/012
Ethics committee name [3] 3383 0
St. Vincent's Hospital
Ethics committee address [3] 3383 0
Ethics committee country [3] 3383 0
Australia
Date submitted for ethics approval [3] 3383 0
Approval date [3] 3383 0
14/07/2007
Ethics approval number [3] 3383 0
H07/005
Ethics committee name [4] 3384 0
Queen Elizabeth Hospital
Ethics committee address [4] 3384 0
Ethics committee country [4] 3384 0
Australia
Date submitted for ethics approval [4] 3384 0
Approval date [4] 3384 0
02/07/2007
Ethics approval number [4] 3384 0
2007015
Ethics committee name [5] 289751 0
Princess Alexandra Hospital
Ethics committee address [5] 289751 0
Ethics committee country [5] 289751 0
Australia
Date submitted for ethics approval [5] 289751 0
Approval date [5] 289751 0
16/04/2013
Ethics approval number [5] 289751 0
HREC/13/QPAH/104
Ethics committee name [6] 289752 0
Queen Elizabeth Hospital
Ethics committee address [6] 289752 0
Ethics committee country [6] 289752 0
Australia
Date submitted for ethics approval [6] 289752 0
Approval date [6] 289752 0
12/04/2013
Ethics approval number [6] 289752 0
HREC/13/TQEHLMH/3
Ethics committee name [7] 289753 0
St Vincent's Hospital
Ethics committee address [7] 289753 0
Ethics committee country [7] 289753 0
Australia
Date submitted for ethics approval [7] 289753 0
Approval date [7] 289753 0
09/04/2013
Ethics approval number [7] 289753 0
LNR/13/SVH/124

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

Contacts
Principal investigator
Name 27485 0
Prof Simon Stewart
Address 27485 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 27485 0
Australia
Phone 27485 0
+61399533677
Fax 27485 0
+61396635726
Email 27485 0
[email protected]
Contact person for public queries
Name 10740 0
Simon Stewart
Address 10740 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 10740 0
Australia
Phone 10740 0
+61399533677
Fax 10740 0
+61396635726
Email 10740 0
[email protected]
Contact person for scientific queries
Name 1668 0
Simon Stewart
Address 1668 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 1668 0
Australia
Phone 1668 0
+61399533677
Fax 1668 0
+61396635726
Email 1668 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 challenge of comorbidity in clinical trials for multiple sclerosis.2016https://dx.doi.org/10.1212/WNL.0000000000002471
N.B. These documents automatically identified may not have been verified by the study sponsor.