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Trial registered on ANZCTR


Registration number
ACTRN12614000916640
Ethics application status
Approved
Date submitted
18/08/2014
Date registered
27/08/2014
Date last updated
24/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does technology improve the compliance of daily weight monitoring in community dwelling people who have chronic heart failure.
Scientific title
In community dwelling people who have chronic heart failure, do the use of scales with memory versus scales with memory and enhanced remote access, improve daily weight monitoring compliance.
Secondary ID [1] 284954 0
Nil
Universal Trial Number (UTN)
U1111-1159-0902
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 292440 0
Condition category
Condition code
Cardiovascular 292750 292750 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who consent to participate in the trial will be randomised to one of two groups:

(a) Usual Care Group
(b) Enhanced Care Group

(a) Usual Care Group
Participants in the Usual Care Group will receive the usual standard-of-care as provided by their GP and Cardiologists. Usual care advice and treatment for people with CHF typically involves patient education (eg, importance of daily weight monitoring, fluid restriction monitoring), daily monitoring of body weight, and visits to their GP or other health care providers according to their self-assessment. As per the usual standard-of-care, patients in the Usual Care Group will be required to monitor their weight on a daily basis and record their weight measurements in a weight diary. The study team will provide the Usual Care Group with an electronic weight scale with memory for self-monitoring. The data gathered in the weight scale will be stored in the scale’s memory and extracted at regular intervals by the research team over a 12 month period.

(b) Enhanced Care Group
Participants in the Enhanced Care Group will receive a revised model of the usual standard care for chronic heart failure patients as provided by their GP and Cardiologist. As per the usual standard-of-care, patients in the Enhanced Care Group will be required to monitor their weight on a daily basis. The Enhanced Care Group will be provided with an electronic weight scale (with memory); however the weight measurements will be recorded in real time via remote monitoring over a 12 month period.

Participants in the both groups will also complete a series of assessments at baseline, 6-months and 12-months which will involve:

* Collection of demographic details
* Previous clinical history
* Risk factor assessment
* Quality of life assessment
* Functional or physical capacity
* Health behaviours
* Medication management
* Symptoms
* Participant usability evaluation questionnaire (at 12 months only)

Intervention code [1] 290011 0
Behaviour
Comparator / control treatment
As per the usual standard-of-care, patients in the Control Group will be required to monitor and log their weight on a daily basis over 12 months. To obtain an objective measure of the frequency of weight measurement in the trial patients, the study team will provide the Control Group with an electronic weight scale for self-monitoring. The data gathered in the weight scale will be stored in memory and downloaded at three monthly intervals by the research team.

The comparator being studied is the compliance rate of daily weight monitoring and recording of patients in the Control Group compared with the Intervention Group. The aim is to investigate if there is an improvement in daily weight compliance in the Intervention Group compared with the Control Group.
Control group
Active

Outcomes
Primary outcome [1] 292909 0
Primary Outcome 1: Compliance rate of daily weight monitoring in Enhanced Care Group versus Usual Care Group. The patient weight data will be collected from the electronic weight scale and downloaded at regular intervals by the research team. For the Control Group this will be done manually by the research team at three monthly intervals. For the Intervention Group this will be done automatically after each weight measurement by the remote monitoring system.
Timepoint [1] 292909 0
Timepoint: at one year after randomisation as assessed by daily weight measurements between the Enhanced Care Group and Usual Care Group.
Secondary outcome [1] 309907 0
Secondary Outcome 1: Hospital re-admission rate of patients as assessed by data linkage to medical records
Timepoint [1] 309907 0
Timepoint: at 6-12 months after randomisation.
Secondary outcome [2] 309908 0
Secondary Outcome 2: Mortality rate of patients as assessed by data linkage to medical records
Timepoint [2] 309908 0
Timepoint: at 6-12 months after randomisation.
Secondary outcome [3] 309909 0
Secondary Outcome 3: Risk factor management by patients as assessed by data linkage to medical records (eg. hospital admission rate and length of stay) and patient assessment tools including:
(1) Quality of Life Assessments: EQ-5D-5L Questionnaire and Cardiac Depression Scale.
(2) Self-Management Assessments: Heart Failure Compliance Questionnaire
(3) Physical Capacity Assessments: The Six Minute Walk Test and Clinical Frailty Scale
Timepoint [3] 309909 0
Timepoint: at 6-12 months after randomisation.
Secondary outcome [4] 309910 0
Secondary Outcome 4:
Symptoms management by patients as assessed by data linkage to medical records (eg. hospital admission rate and length of stay) and patient assessment tools.

1) Quality of Life Assessments:

a) EQ-5D-5L Health Questionnaire is a questionnaire which asks about health related quality of life. It asks about patient mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.



b) The Cardiac Depression Scale assesses depression in adult cardiac populations. It asks several questions about the sleep patterns and general mood of patients with cardiac problems.

2) Self-Management Assessments:

a) The Heart Failure Compliance Questionnaire asks for the patient’s view about how well they follow their medical treatments. This information helps keep track of how much difficulty a patient has with specific lifestyle behaviours, such as taking medications regularly.

3) Physical Capacity Assessments:

a) The Six Minute Walk Test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The test is used evaluate the functional capacity of patients with Chronic Heart Failure.


b) The Clinical Frailty Scale categorises frailty based on physical and functional indicators or health, such as mobility and function, with scores that range from 1 (very fit) to 9 (terminally ill).

Timepoint [4] 309910 0
Timepoint: at 6-12 months after randomisation.
Secondary outcome [5] 309911 0
Secondary Outcome 5: Medication compliance by patients as assessed by data linkage to medical records (eg. hospital admission rate and length of stay) and patient assessment tools.
a) The Heart Failure Compliance Questionnaire asks for the patient’s view about how well they follow their medical treatments. This information helps keep track of how much difficulty a patient has with specific lifestyle behaviours, such as taking medications regularly.

Timepoint [5] 309911 0
Timepoint: at 6-12 months after randomisation
Secondary outcome [6] 309912 0
Quality of life of patients as assessed by patient quality of life assessment tools, including:

a) EQ-5D-5L Health Questionnaire is a questionnaire which asks about health related quality of life. It asks about patient mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

b) The Cardiac Depression Scale assesses depression in adult cardiac populations. It asks several questions about the sleep patterns and general mood of patients with cardiac problems.
Timepoint [6] 309912 0
Timepoint: at 6-12 months after randomisation
Secondary outcome [7] 309913 0
Psychosocial status of patients as assessed by patient quality of life assessment tools, including:

a) EQ-5D-5L Health Questionnaire is a questionnaire which asks about health related quality of life. It asks about patient mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

b) The Cardiac Depression Scale assesses depression in adult cardiac populations. It asks several questions about the sleep patterns and general mood of patients with cardiac problems.

Timepoint [7] 309913 0
Timepoint: at 6-12 months after randomisation

Eligibility
Key inclusion criteria
Eligible participants will be patients diagnosed with chronic heart failure. Inclusion criteria are that the participants must:

1. Diagnosed as having chronic heart failure by a clinician
2. Be able to weigh themselves safely
3. At least 18 years of age
4. Have regular GP/agree to use GP designated by the patient
5. Have permanent residential address
6. Able to individually consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for participation in the project if they

1. Have life expectancy less than12 months
2. Have end stage renal failure on dialysis
3. Are long term nursing home resident
4. Have severe 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)
Once patients have signed the Consent Form, they will be provided with a blank envelope by the research nurse containing their designated trial group (Enhanced Care Group or Usual Care Group). The envelope contents will be pre-prepared by CSIRO’s Australian e-Health Research Centre.

The envelopes will be blank, to ensure that the allocation process is concealed from the person requesting consent (i.e. the research nurse). However, the patient will notify the research nurse which group they have been randomised to, in order to facilitate further care planning.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelope contents will be pre-prepared by CSIRO’s Australian e-Health Research Centre, using a permutated block randomisation system
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Objective: Evaluate the compliance rate in weight management (number of patients weighting themselves daily / number of patients incompliant with this requirement) between the Enhanced Care Group Group (A0) than Usual Care Group (A1) in the trial.

Allocation Ratio: 1:1 (RCT)

Null hypothesis (H0): the compliance rate in A0 is equal to the rate in A1

Setup variables:

Power (1- Beta): 80% (Type II error, false negative)

Statistical Significance Level (a): 5% (Type I error, false positive)

Assumption: Assume we know the following two variables from literature

1.Compliance rate in the Enhanced Care Group is 80%.
2.Compliance rate in the Usual Care Group is 64%.
3.Completion rate for analysis (some patients drop out or are discharged due to mortality) is 90%.

Results: The calculated sample size is 148 patients in each group.



A Chi-squared test will be used to analyse dichotomous data with large sizes, such as the compliance, and readmission. ANOVA will be applied to analyse continuous data such weight variations. A Fisher’s exact test will be employed, if data size of some measures is small. A Cox proportional hazards model will be performed to analyse the risk of mortality. The influence of risk factors such as aging will be considered in the analysis, and 95% confidence intervals will be estimated

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2844 0
Frankston Hospital - Frankston
Recruitment hospital [2] 2845 0
Rosebud Hospital - Rosebud
Recruitment hospital [3] 7373 0
St John of God Nepean Rehabilitation Hospital - Frankston
Recruitment hospital [4] 7374 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 7375 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 8532 0
3199 - Frankston
Recruitment postcode(s) [2] 8533 0
3939 - Rosebud
Recruitment postcode(s) [3] 15168 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 289769 0
Government body
Name [1] 289769 0
Department of State Development, Business and Innovation
Address [1] 289769 0
121 Exhibition Street, Melbourne, Vic, 3001
Country [1] 289769 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
PO Box 52
Frankston, VIC, 3199
Country
Australia
Secondary sponsor category [1] 288458 0
None
Name [1] 288458 0
Address [1] 288458 0
Country [1] 288458 0
Other collaborator category [1] 278083 0
Commercial sector/Industry
Name [1] 278083 0
Medtech Global
Address [1] 278083 0
Level 2
180 Albert Road
South Melbourne VIC 3205
Country [1] 278083 0
Australia
Other collaborator category [2] 278084 0
Government body
Name [2] 278084 0
CSIRO (The Australian e-Health Research Centre)
Address [2] 278084 0
Level 5, UQ Health Sciences Building
Bowen Bridge Rd
Royal Brisbane and Women's Hospital
Hertson QLD 4029
Country [2] 278084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291497 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 291497 0
PO Box 52
Frankston VIC 3199
Ethics committee country [1] 291497 0
Australia
Date submitted for ethics approval [1] 291497 0
25/08/2014
Approval date [1] 291497 0
18/11/2014
Ethics approval number [1] 291497 0
HREC14PH27
Ethics committee name [2] 296755 0
St John of God HREC
Ethics committee address [2] 296755 0
Level 3, St John of God House,
177-179 Cambridge St,
WEMBLEY WA 6014
Ethics committee country [2] 296755 0
Australia
Date submitted for ethics approval [2] 296755 0
Approval date [2] 296755 0
03/07/2015
Ethics approval number [2] 296755 0
HREC#779
Ethics committee name [3] 296756 0
Royal Perth Hospital HREC
Ethics committee address [3] 296756 0
Research Ethics and Governance
Level 3, Colonial House
Royal Perth Hospital
Wellington Street, PERTH WA 6000
Ethics committee country [3] 296756 0
Australia
Date submitted for ethics approval [3] 296756 0
Approval date [3] 296756 0
Ethics approval number [3] 296756 0
15-081

Summary
Brief summary
The objective of the clinical trial is to demonstrate that monitoring of weight improves the compliance rate of CHF patient’s to self-monitor their daily weight, as well as potentially improved quality of life, enhanced management of risk factors and medication, increased cost benefits and reduced hospital readmissions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49822 0
Mr Iain Edwards
Address 49822 0
Director, Integrated Care & Dental
Rosebud Community Health
38 Braidwood Avenue
ROSEBUD VIC 3939
Country 49822 0
Australia
Phone 49822 0
+61 3 5986 9265
Fax 49822 0
+61 3 5986 9251
Email 49822 0
iainedwards@phcn.vic.gov.au
Contact person for public queries
Name 49823 0
Mr Iain Edwards
Address 49823 0
Director, Integrated Care & Dental
Rosebud Community Health
38 Braidwood Avenue
ROSEBUD VIC 3939
Country 49823 0
Australia
Phone 49823 0
+61 3 5986 9265
Fax 49823 0
+61 3 5986 9251
Email 49823 0
iainedwards@phcn.vic.gov.au
Contact person for scientific queries
Name 49824 0
Dr Hang Ding
Address 49824 0
The Australian E-Health Research Centre (CSIRO)
Level 5, UQ Health Sciences Building 901/16
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital
Brisbane QLD 4029
Country 49824 0
Australia
Phone 49824 0
+61 7 3253 3623
Fax 49824 0
Email 49824 0
hang.ding@csiro.au

No information has been provided regarding IPD availability
Summary results
No Results