Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001237673
Ethics application status
Approved
Date submitted
7/11/2014
Date registered
26/11/2014
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telemedicine in Kidney Disease Study
Scientific title
An interventional prospective cohort study with matched control group to compare a telemedicine model of care for prevalent renal transplant recipients and Chronic Kidney Disease patients with standard medical care to assess the feasibility of a telemedicine model of care
Secondary ID [1] 285608 0
Nil
Universal Trial Number (UTN)
U1111-1163-8075
Trial acronym
TIKED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 293456 0
Renal Transplant Recipient 293457 0
Condition category
Condition code
Renal and Urogenital 293737 293737 0 0
Kidney disease
Public Health 293832 293832 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who meet the inclusion criteria will be offered to have up to 75% of their clinic appointments by telemedicine.
The study intervention will be the use of intermittent telemedicine consultations to the patient in their own home (using the QLD Health approved Cisco Jabber Program) or at a nearby health facility (Gympie, Caloundra, Maleny), combined with some face to face consultations (at Nambour Hospital). The frequency of telemedicine consultations will be as deemed suitable by the medical staff but will not exceed 75% of consultations. The Duration of intervention will be 24 months.
Intervention code [1] 290562 0
Treatment: Devices
Comparator / control treatment
Standard face to face consultations with Nephrologist in Outpatient Department.
The matched control group will be asked to consent to compare with the telemedicine group. This group will not have been offered telemedicine (usually due to living near Nambour Hospital) but would be considered suitable by medical staff if they live further away. This group will be matched with the telemedicine group for transplant / CKD status, age, gender, and diabetic status.
Control group
Active

Outcomes
Primary outcome [1] 293536 0
Feasibility of a telemedicine model of care (>25% of consultations are conducted by telemedicine)
Timepoint [1] 293536 0
1 and 2 year
Secondary outcome [1] 311286 0
Compare change in quality of care indicators, these include blood pressure readings using automatic sphygmomanometer, serum creatinine assay, estimated Glomerulofiltration Rate assay, total cholesterol assay, HbA1c assay (if diabetic), weight, body mass index in the telemedicine group and matched cohort over a 2 year prospective period
Timepoint [1] 311286 0
At 6 month intervals up to 24 months
Secondary outcome [2] 311288 0
Compare travel distance to appointments using google maps distance calculator in both telemedicine and matched cohort over a 2 year prospective period
Timepoint [2] 311288 0
At 6 month intervals up to 24 months
Secondary outcome [3] 311289 0
Compare the uptake of telemedicine (percentage of all appointments) in the first 12 months with the second 12 month prospective period
Timepoint [3] 311289 0
1 and 2 years
Secondary outcome [4] 311599 0
record number of hospitilisations of each participant in both telemedicine and matched cohort
Timepoint [4] 311599 0
At 6 month intervals up to 24 months
Secondary outcome [5] 311600 0
Patient satisfaction as measured by a response to question "out of 10 (10 = Excellent and 0 = very bad), how would you rate your entire experience with all staff and services at the Sunshine Coast HHS Renal Unit?"in both telemedicine and matched cohort
Timepoint [5] 311600 0
At 6 month intervals up to 24 months

Eligibility
Key inclusion criteria
1.Age >=18 years and able to give informed consent
2.Patient living at least 15km from the specialist clinic or in an aged care facility
3.Deemed suitable for telemedicine care as determined by the medical team
4.Must be a patient attending the Sunshine Coast Hospital and Health Service, renal service with a functioning renal transplant or a diagnosis of Chronic Kidney Disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Poor compliance as determined by medical staff
2.Cognitive impairment
3.Life expectancy (<1 year)
4.Interpreter required
5.Inability to access (or use) a computer with webcam and “Cisco Jabber” software, or inability to attend a local health centre with telemedicine available
6.Unable to measure blood pressure prior to the appointment (at home, chemist, GP, local health centre, other)
7.Unable to weigh at home or the health centre that has a telemedicine clinic
8.Unable to perform pathology prior to the appointment
9.Participation in another research study
10.Pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who meet the inclusion criteria will be offered to have up to 75% of their clinic appointments by telemedicine.
The frequency of telemedicine consultations will be as deemed suitable by the medical staff but will not exceed 75% of consultations.
A matched control group will be asked to consent to compare with the telemedicine group. This group will not have been offered telemedicine (usually due to living near Nambour Hospital) but would be considered suitable by medical staff if they live further away.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is not a randomised study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients who are offered telemedicine, but decline to participate in telemedicine, will be asked to consent to complete a questionnaire about their demographics and reasons for declining telemedicine.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To ascertain differences between the two groups at baseline, demographic, comorbidity, and physiological data will be analysed using mean (standard deviation) or median (interquartile range) where appropriate. Differences in satisfaction will be examined in the same way.
Serial data including pathological and physiological, will be analysed using a linear and correlated regression model.
Time to event data (eg hospitalisation) will be analysed using a Cox type regression model.
For all analyses, the level of significance will be set at P < 0.05.
Data will be analysed using STATATM version 12.0.
There is no sample size calculation as this is a feasibility study and no data to base a power calculation on.
The number selected is based on current patient numbers and location of residence such that we believe there will be enough available to recruit.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/01/2015
Actual
19/05/2015
Date of last participant enrolment
Anticipated
26/12/2016
Actual
7/06/2016
Date of last data collection
Anticipated
7/06/2018
Actual
18/06/2018
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3127 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 8877 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 290202 0
Other Collaborative groups
Name [1] 290202 0
Sunshine Coast Private Practice Trust Fund
Country [1] 290202 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Nicholas Andrew Gray, Director of Renal Services at SCHHS - Nambour General Hospital
Address
Renal Department
Nambour General Hospital
Hospital Road
Nambour 4560
Queensland
Country
Australia
Secondary sponsor category [1] 288914 0
None
Name [1] 288914 0
Address [1] 288914 0
Country [1] 288914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291913 0
Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 291913 0
Ethics committee country [1] 291913 0
Australia
Date submitted for ethics approval [1] 291913 0
13/11/2014
Approval date [1] 291913 0
01/12/2014
Ethics approval number [1] 291913 0
HREC/14/QPCH/250

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

Contacts
Principal investigator
Name 52570 0
A/Prof Nicholas Andrew Gray
Address 52570 0
Nambour General Hospital
Hospital Road
Nambour 4560
Queensland
Country 52570 0
Australia
Phone 52570 0
61 7 5470 6504
Fax 52570 0
61 7 5470 6129
Email 52570 0
[email protected]
Contact person for public queries
Name 52571 0
Andrea Pollock
Address 52571 0
Clinical Trials Department
Sunshine Coast Academic and Research Center
5 Waterfall Road
Nambour
Queensland 4560
Country 52571 0
Australia
Phone 52571 0
61 7 5370 3514
Fax 52571 0
61 7 5470 5515
Email 52571 0
[email protected]
Contact person for scientific queries
Name 52572 0
Nicholas Gray
Address 52572 0
Nambour General Hospital
Hospital Road
Nambour 4560
Queensland
Country 52572 0
Australia
Phone 52572 0
61 7 5470 6504
Fax 52572 0
61 7 5470 6129
Email 52572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Do not have permission


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
EmbaseTelemedicine for Outpatient Care of Kidney Transplant and CKD Patients.2021https://dx.doi.org/10.1016/j.ekir.2021.02.016
N.B. These documents automatically identified may not have been verified by the study sponsor.