Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000082202
Ethics application status
Approved
Date submitted
18/09/2008
Date registered
4/02/2009
Date last updated
2/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A research study to evaluate the "current management" of patients with chronic heart failure with the "usual care" plus "additional" remote monitoring by study doctors and a research nurse
Scientific title
A prospective randomised controlled trial to evaluate the effects of remote physiological monitoring for chronic heart failure (CHF) on emergency department presentations and unplanned hospital admissions for chronic heart failure.
Secondary ID [1] 723 0
Nil
Universal Trial Number (UTN)
Trial acronym
WATCH Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 3710 0
Condition category
Condition code
Cardiovascular 3877 3877 0 0
Coronary heart disease
Cardiovascular 3878 3878 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 months daily home electronic measurements by patients of their physiological parameters - 1. Pulse rate & Electrocardiograph (ECG) by placing their hands on an "external monitoring plate" 2. Temperature & Oxygen Saturation by digital pulse oximetry 3. Blood pressure by automated cuff measurements 4. Weight by external scales. The above modules are attached to the remote monitoring system and measurements are transmitted via the patients telephone line to a central monitoring database and accessed by the study Doctor and Research Nurse to facilitate early medical intervention. 5. Daily Patient Health Diary entries will be recorded manually and entered electronically at a later time by trial staff. 6. Quality of Life Questionnaires will be recorded by trial staff addressing each question over the telephone with the patient. 7. Health Record review by trial staff on site will be manual and electronic. 8. General Practitioner visits and communication will be recorded manually by the patient in the daily Patient Health Diary. Actions/treatments initiated during patient General Practitioner visits will be clarified by trial staff with the relevant General Practitioner as necessary.
Intervention code [1] 3422 0
Early detection / Screening
Intervention code [2] 3423 0
Prevention
Intervention code [3] 3424 0
Treatment: Other
Comparator / control treatment
12 months usual medical management for chronic heart failure at Sir Charles Gairdner Hospital including written patient education and phone support. Management by the patients General Practitioner and Cardiologist scheduled reviews for the management of Chronic Heart Failure will continue.
Control group
Active

Outcomes
Primary outcome [1] 4780 0
Daily review of the transmitted parameters by research personnel. This includes the review of Patient Health Diary entries, Quality of Life Questionnaire completion, Health Record review and communication with the subjects General Practitioner (GP).
Timepoint [1] 4780 0
Daily for 12 months
Primary outcome [2] 4810 0
A reduction in Emergency Department presentations related to chronic heart failure measured by assessment/analysis of 'adverse event' entries in a Patient Health Diary and by Health Record review that will include review of hospital morbidity data only available retrospectively.
Timepoint [2] 4810 0
Daily for 12 months
Secondary outcome [1] 8116 0
A reduction in emergency admissions & unplanned hospital admissions related to chronic heart failure measured by assessment/analysis of 'adverse event' entries in a Patient Health Diary and by Health Record review that will include review of hospital morbidity data only available retrospectively.
Timepoint [1] 8116 0
Daily for 12 months
Secondary outcome [2] 8117 0
Economic (Cost Utility Analyses)
Timepoint [2] 8117 0
At 12 months
Secondary outcome [3] 8155 0
Quality of Life (Minnesota Living with Heart Failure Questionnaire and the Australian Quality of Life Questionnaire)
Timepoint [3] 8155 0
Baseline, 6-months and 12 months
Secondary outcome [4] 9020 0
Safety, a reduction in the patients chronic heart failure severity level by assessment of the stage of heart failure according to the New York Heart Association (NYHA) functional classification system.
Timepoint [4] 9020 0
Baseline, 6-months and 12 months

Eligibility
Key inclusion criteria
Age > 65 years, primary diagnosis of chronic heart failure, New York Heart Association (NYHA) > Grade 2, can give informed consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented cognitive deficit, non-english speaking or participation in another trial

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)
After a subject is deemed eligible for inclusion in the trial they will be invited to consider their participation in the study. All study personnel will be unaware to which group the subject will be allocated until after randomisation. The subject will attend an Informed Consent Visit and, if agreeable, they will be randomised to either the conservative or the technology based arm of the study. A password protected computer with a computer program designed to sequentially allocate the computer generated numbers will be used for randomisation. The computer generated numbers will be electronically allocated on request.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomised to one of two groups using a set of computer generated numbers matched to their Unit Record Number on a sequential basis
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3892 0
Government body
Name [1] 3892 0
Western Australia (WA) Department of Health
Country [1] 3892 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
1 Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 3494 0
Hospital
Name [1] 3494 0
Heart Research Institute
Address [1] 3494 0
Sir Charles Gairdner Hospital
Level 1, C Block
Hospital Avenue
Nedlands WA 6009
Country [1] 3494 0
Australia
Other collaborator category [1] 421 0
Commercial sector/Industry
Name [1] 421 0
TeleMedCare Pty Ltd
Address [1] 421 0
Suite 7
6-8 Crewe Place
Roseberry NSW 2018
Country [1] 421 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5943 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 5943 0
Level 1, E Block
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 5943 0
Australia
Date submitted for ethics approval [1] 5943 0
15/05/2008
Approval date [1] 5943 0
03/07/2008
Ethics approval number [1] 5943 0
2008-035

Summary
Brief summary
Physiological monitoring of community patients with at-risk chronic heart failure randomised into one of 2-groups. Group 1 -Current management by the Sir Charles Gairdner Hospital Heart Failure Clinic including written Patient Education + Phone Support compared with Group 2 - Home computer recording of physiological measurements by the patient and centrally evaluated by the Trial Nurse / Doctor. We hypothesise that daily review of physiological parameters will facilitate early medical intervention and thereby reduce emergency department presentations and unplanned hospital admissions for chronic heart failure.
Trial website
Not applicable
Trial related presentations / publications
Nil at present
Public notes

Contacts
Principal investigator
Name 28947 0
Address 28947 0
Country 28947 0
Phone 28947 0
Fax 28947 0
Email 28947 0
Contact person for public queries
Name 12104 0
Professor Peter Thompson
Address 12104 0
Heart Research Institute
Level 1, C Block
Sir Charles Gairdner Hospital
Western Australia 6009
Country 12104 0
Australia
Phone 12104 0
08 9346 3333
Fax 12104 0
08 9356 4537
Email 12104 0
[email protected]
Contact person for scientific queries
Name 3032 0
Professor Peter Thompson
Address 3032 0
Level 1, C Block
Sir Charles Gairdner Hospital
Nedlands WA 6009
Country 3032 0
Australia
Phone 3032 0
08 9346 3333
Fax 3032 0
08 9346 4537
Email 3032 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
No additional documents have been identified.