Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001007224
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
15/06/2018
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth for palliative care patients in metropolitan and rural settings.
Scientific title
A prospective randomised controlled study of telehealth specialist palliative care consultations in rural and metropolitan settings and the impact on patient and carer clinical outcomes and quality-of-life.
Secondary ID [1] 294999 0
HREC/18/MonH/348
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
ACTRN12618000950268
The linked registration was a pilot study.

Health condition
Health condition(s) or problem(s) studied:
cancer 308021 0
chronic disease 308022 0
Palliative Care 308023 0
Condition category
Condition code
Cancer 307057 307057 0 0
Any cancer
Cardiovascular 307058 307058 0 0
Coronary heart disease
Cardiovascular 307105 307105 0 0
Other cardiovascular diseases
Musculoskeletal 307106 307106 0 0
Osteoarthritis
Musculoskeletal 307107 307107 0 0
Osteoporosis
Musculoskeletal 307108 307108 0 0
Other muscular and skeletal disorders
Neurological 307109 307109 0 0
Other neurological disorders
Neurological 307110 307110 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telehealth: using a secure medical consultation dedicated teleconference system to enable in home consultation between a physician and patient in their home and addresses any issues raised by the general practitioner referral. A 45-minute specialist palliative care physician consultation via videoconference with nurse facilitation as would occur in any joint physician and nursing visit. A research assistant shall assist in the equipment setup and also helps in collecting data monthly. No training required for participants.
Initial consultations occur 2 weeks post randomisation and then as required without limitation for 3 months and consultations lasting as long as required.
Intervention code [1] 301340 0
Treatment: Other
Comparator / control treatment
Standard care: being all usual care provided included by community palliative care, other community services, hospital services, specialists and general practice.
Control group
Active

Outcomes
Primary outcome [1] 306029 0
Clinical symptoms: utilising the palliative care "symptom assessment scale", an 11-point numeric scale from 0 to 10 for appetite, sleep, nausea, pain, fatigue, breathing problems, bowel problems.
Timepoint [1] 306029 0
3 month post randomisation into study.
Initially at 2 weeks post randomisation then monthly
However towards the end of life will be collected at each clinical interaction which is dictated by need.
Primary outcome [2] 306030 0
Quality-of-life measures; McGulls Quality-of-Life Questionnaire
Timepoint [2] 306030 0
3 months post randomisation
Initially at 2 weeks post randomisation then monthly
However towards the end of life will be collected at each clinical interaction but shall only be a single item score.
Primary outcome [3] 306031 0
Performance Status as measured by the Australian-modified Karnofsky Performance Scale (AKPS)
Timepoint [3] 306031 0
3 months post randomisation.
Initially at 2 weeks post randomisation then monthly
However towards the end of life will be collected at each clinical interaction which is dictated by need.
Secondary outcome [1] 347386 0
Number of emergency department attendances
Data shall be collected from patient medical records and where possible health data linkage
Timepoint [1] 347386 0
over the 3 months post randomisation
Secondary outcome [2] 347460 0
Teleconsultation efficiency: time to set up equipment,
Research assistant attending consultation measures and records duration.
Timepoint [2] 347460 0
2 weeks post randomisation
Secondary outcome [3] 347461 0
User experience: a patient and carer feedback form - a 5 point scale from strongly disagree to strongly agree, including feedback on the telehealth consultation utility, process, equipment, communication quality and comparison to face-face consultation
This questionnaire has been specifically designed for this study.
Timepoint [3] 347461 0
After first consultation at 2 weeks post randomisation
Secondary outcome [4] 347927 0
Health professional rated score for symptom severity which is a 4 point scale for each of pain, other symptoms, psycho-spiritual distress and carer distress.
Timepoint [4] 347927 0
3 month post randomisation
Secondary outcome [5] 347928 0
Quality-of-Life in Life Threatening Illness (Family Version)
Timepoint [5] 347928 0
3 month post randomisation
Secondary outcome [6] 347929 0
Hospital Anxiety and Depression Scale
Timepoint [6] 347929 0
3 months post randomisation
Secondary outcome [7] 347930 0
Hospital admissions
Data shall be collected from patient medical records and where possible health data linkage
Timepoint [7] 347930 0
3 months post randomisation
Secondary outcome [8] 347931 0
Home visit duration
Timepoint [8] 347931 0
2 weeks post randomisation
Research assistant attending consultation measures and records duration.

Eligibility
Key inclusion criteria
Patients admitted to an associated community palliative care service, a Monash Health inpatient palliative care unit, be engaged with a Monash Health palliative care consult service or the Monash Health Oncology Supportive Care Outpatient Clinic.
Diagnosis of a life-limiting illness.
18 years or above
Able to complete informed consent
Able to complete study questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living in an area with inadequate internet connection to perform telehealth

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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be conducted by using STATA software. Data cleaning will be performed via statistical software. All statistical tests will be done two-tailed with 95% confidence intervals. For patients ‘lost to final follow-up’, data collected from consent to the time of the last contact will be included in analyses.

Descriptive statistics. Normally distributed quantitative data will be analyzed by mean and standard deviation. Data that are not normally distributed will be reported by median and inter-quartile range. Qualitative data will be reported by frequency distributions and percentages.

Multivariate analysis. Our primary objective is to detect differences in the quality-of-life and symptom and palliative care outcome scale scores between groups of patients with and without the telehealth service by the ANCOVA model. The result will be adjusted by baseline score to reduce the bias. Because the study design involves a pretest, repeated measures, data will be analyzed with Linear Mixed Models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2018
Actual
29/06/2018
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
140
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11009 0
West Gippsland Healthcare Group - Warragul
Recruitment hospital [2] 13563 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 13564 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 22792 0
3168 - Clayton
Recruitment postcode(s) [2] 22800 0
3820 - Warragul
Recruitment postcode(s) [3] 26208 0
3165 - East Bentleigh
Recruitment postcode(s) [4] 26209 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 299585 0
Government body
Name [1] 299585 0
Victorian Cancer Agency - Department of Health Vic
Country [1] 299585 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Health
264 Clayton Road
Clayton
VICTORIA 3168
Country
Australia
Secondary sponsor category [1] 298904 0
None
Name [1] 298904 0
Address [1] 298904 0
Country [1] 298904 0
Other collaborator category [1] 280130 0
Hospital
Name [1] 280130 0
West Gippsland Healthcare Group
Address [1] 280130 0
41 Landsborough Street
Warragul
Victoria 3820
Country [1] 280130 0
Australia
Other collaborator category [2] 280131 0
Government body
Name [2] 280131 0
Latrobe Community Health Services
Address [2] 280131 0
Latrobe Community Health Services
PO Box 1488
Traralgon
Victoria 3844
Country [2] 280131 0
Australia
Other collaborator category [3] 280132 0
Other
Name [3] 280132 0
Palliative Care South East
Address [3] 280132 0
Palliative Care South East
140-154 Sladen St,
Cranbourne
VIC 3977
Country [3] 280132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300487 0
Monash Health
Ethics committee address [1] 300487 0
Ethics committee country [1] 300487 0
Australia
Date submitted for ethics approval [1] 300487 0
20/04/2018
Approval date [1] 300487 0
29/05/2018
Ethics approval number [1] 300487 0
HREC/18/MonH/348

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

Contacts
Principal investigator
Name 83814 0
A/Prof Peter Poon
Address 83814 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83814 0
Australia
Phone 83814 0
+613 9594 5347
Fax 83814 0
+613 9594 6344
Email 83814 0
[email protected]
Contact person for public queries
Name 83815 0
Peter Poon
Address 83815 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83815 0
Australia
Phone 83815 0
+613 9594 5347
Fax 83815 0
+613 9594 6344
Email 83815 0
[email protected]
Contact person for scientific queries
Name 83816 0
Peter Poon
Address 83816 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83816 0
Australia
Phone 83816 0
+613 9594 5347
Fax 83816 0
+613 9594 6344
Email 83816 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
No IPD will be available.


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.