Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000407493
Ethics application status
Approved
Date submitted
1/02/2016
Date registered
30/03/2016
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coping intervention for home haemodialysis
Scientific title
Staying Home: A brief psychological intervention enhancing the coping skills of home haemodialysis patients to sustain the home treatment modality.
Secondary ID [1] 288456 0
None
Universal Trial Number (UTN)
U1111-1179-0698
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
home haemodialysis 297482 0
Condition category
Condition code
Renal and Urogenital 297669 297669 0 0
Kidney disease
Mental Health 298189 298189 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psycho-education intervention to teach coping skills
The Coping Skills Intervention is an education program on applying problem solving skills to everyday problems, based on Problem Solving Therapy techniques. It teaches the use of the Stop Slow Down Think and Act (SSTA) approach for coping with stress.
Topics covered include:
* Stress, kidney failure and coping
* Effective problems solving,
* The SSTA method
* Problem solving styles
* Stress and your body
* Stress and your brain,
* Reactions to stress
* Strategies to slow down eg. distraction, mindfulness, relaxation
* The ABC approach to healthy thinking
* Problem solving step by step approach
* Review problem solving outcomes,
* Coping skills resources
Education will take place over 6 sessions during normal dialysis treatment (ie. during nurse supervised dialysis in the home dialysis education unit), one session per week for 6 weeks.
It will be provided as a one-to-one teaching session, following a manualised program.
A Psychology Intern (Provisional Registration with AHPRA) under supervision of Psychologist, will present the program to the participant.
Participant will be given their education booklet for each of the six sessions, to work on during session and to take home to continue with home practice.
Each education session will last approximately one hour.
Each session will be video recorded for review with supervising Psychologist, to ensure consistency of content and format.
Intervention code [1] 293783 0
Behaviour
Comparator / control treatment
Control arm is randomisation to waitlist for participants.
In this period, all participants will receive standard care. After approximately 12 months, waitlisted participants will be offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 297209 0
Time using home haemodialysis (ie. days elapsed since commenced use of dialysis at home), will be recorded by the treating team as part of routine care. This data will be collected as an outcome measure.
Timepoint [1] 297209 0
12 months after enrolment in study.
Secondary outcome [1] 320356 0
Change in psychological distress, pre and post intervention, measured by Kessler Psychological Distress Scale. This instrument has been validated for use in the Australian general population and is available in the public domain. It was used in the Australian Survey of Mental Health and Well-being (1997).
Timepoint [1] 320356 0
Baseline and 6 months after enrolment.
Secondary outcome [2] 320357 0
Change in reported use of adaptive coping strategies as measured by self-report scale, namely Brief COPE. This scale has been validated for use in general populations and is available in public domain. It is not specific to this study. For information on the scale, see journal article: Carver, C. S. (1997). You want to measure coping but your protocol’s too long: Consider the Brief COPE, .International Journal of Behavioral Medicine, 4, 92-100
Timepoint [2] 320357 0
Baseline and 6 months after enrolment.

Eligibility
Key inclusion criteria
Dialysis dependent patients attending home training unit;
Aged 18 or above;
Able to give consent;
Able to use spoken English;
Have a viable vascular access that can be cannulated by patient or their carer/dialysis supporter;
Have expressed intention to use home haemodialysis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No intention to use home haemodialysis;
Within the first 2 weeks of dialysis and potentially affected by uraemia;
Unable to give consent;
Unable to use written English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
10/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292798 0
Hospital
Name [1] 292798 0
Princess Alexandra Hospital
Country [1] 292798 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd, Woolloongabba Queensland 4102
Country
Australia
Secondary sponsor category [1] 291537 0
None
Name [1] 291537 0
Address [1] 291537 0
Country [1] 291537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294300 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 294300 0
Ethics committee country [1] 294300 0
Australia
Date submitted for ethics approval [1] 294300 0
12/05/2015
Approval date [1] 294300 0
28/07/2015
Ethics approval number [1] 294300 0
HREC/15/QPAH/291

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

Contacts
Principal investigator
Name 63218 0
Ms Jane Nearhos
Address 63218 0
Princess Alexandra Hospital
Home Haemodialysis
Burke St Centre 2nd Floor
199 Ipswich Rd
Woolloongabba QLD 4102
Country 63218 0
Australia
Phone 63218 0
+61 7 31761120
Fax 63218 0
Email 63218 0
[email protected]
Contact person for public queries
Name 63219 0
Jane Nearhos
Address 63219 0
Princess Alexandra Hospital
Home Haemodialysis
Burke St Centre 2nd Floor
199 Ipswich Rd
Woolloongabba QLD 4102
Country 63219 0
Australia
Phone 63219 0
+61 7 31761120
Fax 63219 0
Email 63219 0
[email protected]
Contact person for scientific queries
Name 63220 0
Jane Nearhos
Address 63220 0
Princess Alexandra Hospital
Home Haemodialysis
Burke St Centre 2nd Floor
199 Ipswich Rd
Woolloongabba QLD 4102
Country 63220 0
Australia
Phone 63220 0
+61 7 31761120
Fax 63220 0
Email 63220 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
Trial ceased before recruitment.


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.