Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000187741
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
15/02/2013
Date last updated
15/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth Remote Monitoring for People with Multiple Chronic Conditions
Scientific title
Utilising Telehealth Remote Monitoring for individuals with multiple chronic illnesses to reduce hospital admissions and improve self-management behaviours.
Secondary ID [1] 281824 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 288345 0
Asthma 288346 0
Chronic Heart Failure 288347 0
Diabetes 288348 0
Hypertension 288349 0
Condition category
Condition code
Respiratory 288698 288698 0 0
Chronic obstructive pulmonary disease
Cardiovascular 288699 288699 0 0
Coronary heart disease
Respiratory 288700 288700 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomised controlled trial of telehealth remote monitoring of people who have two or more chronic conditions, including; diabetes, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), hypertension and asthma.
Once an individual has consented to take part in the research and been allocated to the telehealth group, the nurse will collect baseline information and assist the participant to complete the research tools. At this time the telehealth nurse will also provide the participant with a calendar and instructions on how to record any health service contact that they have during the data collection period.
The telehealth nurse will then develop an action management plan with the client designed specifically for their chronic diseases and together they will identify the vital signs and relevant health outcomes that will be monitored.

The Telehealth nurse will liaise with the participant’s GP to provide information about the research and provide them with a password to log-in to the monitoring website should they like to review their patient’s daily readings.
The telehealth device will then be programmed to reflect the requirements for each individual participant. Following programming of the device, the telehealth nurse will visit the participant again to install the telehealth equipment and train the participant in its use, as well as the correct use of peripheral devices such as blood pressure monitor, thermometer, blood glucose monitor and pulse oximeter. Depending on individual requirements, participants will measure the following daily:
blood glucose
blood pressure
weight
heart rate
oxygen saturation levels
Questions relating to their general state of health and other symptoms depending on individual requirements

The values for each measure being monitored will be transmitted automatically via the internet to a secure website that can be accessed only by the telehealth nurse and the participants GP. Each participant’s data will be monitored daily by the telehealth nurse and any change in the vital signs indicating deterioration in health will be managed using established care pathways based on the evidence based guidelines for best practice in the management of their particular chronic illnesses. Participants will monitor their vital signs for a duration of 12 months.
Intervention code [1] 286500 0
Early detection / Screening
Intervention code [2] 286501 0
Behaviour
Intervention code [3] 286542 0
Prevention
Comparator / control treatment
Participants randomised to the control group will have the same data collected from them at baseline as the telehealth group. The telehealth nurse will provide participants in this group with a calendar to record health service contacts over the data collection period. This group will not recieve any other intervention and will continue to recieve their normal services from Silver Chain. (Whatever they were recieving before the trial commenced, eg Home Help, Personal Care with showering etc.)

The telehealth nurse will then develop an action management plan with the client designed specifically for their chronic diseases but does not include Telehealth monitoring.

They will also be given a telephone number to ring should they have any queries about their self monitoring over the data collection period which will last for a total duration of 12 months.
Control group
Active

Outcomes
Primary outcome [1] 288844 0
Reduction in ED Presentations, hospitalisations and length of stay.
Timepoint [1] 288844 0
Hospital Admissions, Emergency Department presentations and length of stay will be recorded by participants in a monthly calendar at the time they occur. Each participant will be telephoned monthly by the research assistant to collect this information to add to the health service use database. This information will then be used to analyse all participants health service use after their completion of 12 months on the project.

Additionally, the hospitalisations and emergency presentations of participants for the two years prior to the study will be sort from the Western Australian Linked Data System to determine the impact of the chronic disease on the health service use of the individual participants leading up to the study period.
Secondary outcome [1] 301124 0
Improved quality of life for those in the intervention group compared to the control group.
Timepoint [1] 301124 0
This will be measured at baseline, 6 months and 12 months using the SF-36 QOL tool.
Secondary outcome [2] 301136 0
Improved self-management behaviours.
Timepoint [2] 301136 0
Paticipants will complete the Stanford self-efficacy for managing chronic disease 6-item scale at baseline, 6 months and 12 months. The 6-item scale covers several domains that are common across many chronic diseases including symptom control, role function, emotional functioning and communicating with physicians.
Participants will also be surveyed at the completion of the study(12 months) to collect information on changes in specific behaviours or ways in which they manage their chronic illnesses as a result of recieivng the telehealth monitoring.
Secondary outcome [3] 301137 0
Perceptions on using telehealth technology, benefits and challenges as percieved by participants, their GP's and staff administering the project.
Timepoint [3] 301137 0
Surveys and interviews with staff at the completion on the project (12 months).

Eligibility
Key inclusion criteria
Potential participants will need to meet the following criteria:

Have a diagnosis of two or more chronic conditions (diabetes, COPD, CHF, hypertension and asthma.)
Have been hospitalised at least once in the last 12 months due to their chronic disease or related complications.
Live in the community (Not residential care facilities)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those that have a diagnosis of dementia
Those that are recieving palliative care services
Those that are not physically able to use the telehealth equipment.

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)
Silver Chain clients meeting the selection criteria will be identified using Silver Chain's client information system and will be invited to participate in the research by letter. The letter will include an information statement and explain that they will be contacted by a research nurse within a few days. If when telephoned the client says they are interested in participating in the research, the telehealth nurse will visit them in their own home to further explain the project and answer any questions the individual may have. When all questions have been answered to the client's satisfaction and the nurse has confirmed that the individual meets the selection criteria, the client will be asked to sign the consent form and the nurse will open the study envelope containing group assignment. (Process described under sequence generation section.) The nurse will then inform the participant which group they are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to the commencement of recruitment, 120 study numbers will have been randomly allocated to the intervention or control group (60 in each group), by the Research Officer responsible for the trial. This allocation will be undertaken using the random number generator in the statistical software package, STATA. Envelopes will then be made up which have the study number written on the outside and contain a slip of paper with the group assignment for that number. An electronic master list of the study numbers and group allocation will be kept on a password protected computer and will not be accessible to the nurse who will be recruiting participants.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286738 0
Charities/Societies/Foundations
Name [1] 286738 0
Illawarra Retirement Trust (IRT) Research Foundation
Country [1] 286738 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Silver Chain
Address
6 Sundercombe St, Osborne Park 6017, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 285515 0
None
Name [1] 285515 0
Address [1] 285515 0
Country [1] 285515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288791 0
Silver Chain Human Research Ethics Committee
Ethics committee address [1] 288791 0
Ethics committee country [1] 288791 0
Australia
Date submitted for ethics approval [1] 288791 0
Approval date [1] 288791 0
21/12/2012
Ethics approval number [1] 288791 0
082

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

Contacts
Principal investigator
Name 37266 0
Prof Gill Lewin
Address 37266 0
6 Sundercombe St, Osborne Park 6017, Perth, WA.
Country 37266 0
Australia
Phone 37266 0
+61 8 92016722
Fax 37266 0
Email 37266 0
glewin@silverchain.org.au
Contact person for public queries
Name 37267 0
Kristen De San Miguel
Address 37267 0
6 Sundercombe St, Osborne Park 6017, Perth, WA.
Country 37267 0
Australia
Phone 37267 0
+61 8 92016757
Fax 37267 0
Email 37267 0
kdesanmiguel@silverchain.org.au
Contact person for scientific queries
Name 37268 0
Kristen De San Miguel
Address 37268 0
6 Sundercombe St, Osborne Park 6017, Perth, WA.
Country 37268 0
Australia
Phone 37268 0
+61 8 92016757
Fax 37268 0
Email 37268 0
kdesanmiguel@silverchain.org.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.