Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000950268
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
6/06/2018
Date last updated
6/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telehealth Impact in caring for community palliative care patients in a rural setting
Scientific title
A pilot prospective randomised controlled study of telehealth palliative care in rural community settings and the impact on patient and carer clinical outcomes and quality-of-life.
Secondary ID [1] 295014 0
nil known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 307899 0
chronic disease 307900 0
palliative care 307901 0
Condition category
Condition code
Cancer 306941 306941 0 0
Any cancer
Cardiovascular 307071 307071 0 0
Coronary heart disease
Cardiovascular 307072 307072 0 0
Other cardiovascular diseases
Musculoskeletal 307073 307073 0 0
Osteoarthritis
Musculoskeletal 307074 307074 0 0
Osteoporosis
Musculoskeletal 307075 307075 0 0
Other muscular and skeletal disorders
Neurological 307078 307078 0 0
Other neurological disorders
Neurological 307079 307079 0 0
Neurodegenerative diseases
Neurological 307080 307080 0 0
Dementias
Respiratory 307081 307081 0 0
Chronic obstructive pulmonary disease

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 physician and patient at their home. Approximately 45 minute specialist consultation with nurse facilitation home visit in line with a standard face to face patient specialist review to address the issues for which the referral was made by the GP. This process is assisted by a research assistant who also collects 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] 301249 0
Treatment: Other
Comparator / control treatment
standard care: being all usual care provided including by community palliative care, other community services, hospital services, specialists and general practice.
Control group
Active

Outcomes
Primary outcome [1] 305934 0
clinical symptoms: utilising the palliative care "symptom assessment scale": 11 point numeric scale from 0 to 10 for appetite, sleep, nausea, pain, fatigue, breathing problems, bowel problems.
Timepoint [1] 305934 0
3 month post randomisation into study.
Primary outcome [2] 305935 0
quality of life measures: McGills Quality of Life Questionnaire
Timepoint [2] 305935 0
3 months post randomisation
Primary outcome [3] 306124 0
Health professional rated score for symptom severity: 4 point scale for pain, other symptom, psycho-spiritual distress and carer distress.
Timepoint [3] 306124 0
3 months post randomisation
Secondary outcome [1] 347064 0
User experience; a patient and carer feedback form - Designed specifically for this study - 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.
Timepoint [1] 347064 0
After first consultation at 2 weeks post randomisation
Secondary outcome [2] 347416 0
Medical resource utility including emergency room attendances, hospital admission.
Data shall be collected from patient medical records and where possible health data linkage
Timepoint [2] 347416 0
3 months post randomisation
Secondary outcome [3] 347417 0
Teleconsultation efficiency: time to setup equipment
Timepoint [3] 347417 0
2 weeks post randomisation
Secondary outcome [4] 347629 0
consultation duration - this documented at each consultation by the research assistant who observes each consultation.
Timepoint [4] 347629 0
2 weeks post randomisation
Secondary outcome [5] 347630 0
home visit duration- this documented at each consultation by the research assistant who observes each consultation.
Timepoint [5] 347630 0
2 weeks post randomisation

Eligibility
Key inclusion criteria
diagnosis of 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 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)
random letter table created by STATA software
1:1 randomisation
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
Sample Size : Pilot study only

Statistical analyses will be conducted by using STATA 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. ANCOVA model. and Linear Mixed Models.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11002 0
West Gippsland Healthcare Group - Warragul
Recruitment postcode(s) [1] 22791 0
3820 - Warragul

Funding & Sponsors
Funding source category [1] 299517 0
Government body
Name [1] 299517 0
Victorian Cancer Agency - Department of Health Vic
Country [1] 299517 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Health
246 Clayton Road
Clayton
VICTORIA 3168
Country
Australia
Secondary sponsor category [1] 298814 0
None
Name [1] 298814 0
Address [1] 298814 0
Country [1] 298814 0
Other collaborator category [1] 280112 0
Hospital
Name [1] 280112 0
West Gippsland Health Group
Address [1] 280112 0
West Gippsland Health Group
41 Landsborough St
Warragul
Victoria 3820
Country [1] 280112 0
Australia
Other collaborator category [2] 280113 0
Government body
Name [2] 280113 0
Latrobe Community Health Services
Address [2] 280113 0
Latrobe Community Health Services
PO Box 1488
Traralgon
Victoria 3844
Country [2] 280113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300413 0
West Gippsland Health Group
Ethics committee address [1] 300413 0
Ethics committee country [1] 300413 0
Australia
Date submitted for ethics approval [1] 300413 0
01/07/2015
Approval date [1] 300413 0
31/08/2015
Ethics approval number [1] 300413 0

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

Contacts
Principal investigator
Name 83582 0
A/Prof Peter Poon
Address 83582 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83582 0
Australia
Phone 83582 0
+613 9594 5347
Fax 83582 0
+613 9594 6344
Email 83582 0
peter.poon@monashhealth.org
Contact person for public queries
Name 83583 0
Peter Poon
Address 83583 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83583 0
Australia
Phone 83583 0
+613 9594 5347
Fax 83583 0
+613 9594 6344
Email 83583 0
peter.poon@monashhealth.org
Contact person for scientific queries
Name 83584 0
Peter Poon
Address 83584 0
Monash Health Supportive and Palliative Care
246 Clayton Road,
Clayton Vic 3168
Country 83584 0
Australia
Phone 83584 0
+613 9594 5347
Fax 83584 0
+613 9594 6344
Email 83584 0
peter.poon@monashhealth.org

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.