Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001761853
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
23/12/2021
Date last updated
23/12/2021
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Online support group for haemodialysis patients: a pre post study.
Scientific title
What is the effect of an online support group intervention on quality of life and anxiety and depression in haemodialysis patients?
Secondary ID [1] 305938 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 324534 0
Condition category
Condition code
Renal and Urogenital 322001 322001 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will use their own equipment (Phone/Tablet/Computer) to join a weekly online support group. Using input and engagement from patients and hospital staff a four-week support group will be conducted online using the online TEAMs platform. The online TEAMs support group sessions will run weekly for approximately 1 hour once per week for 4 weeks. This will be a new intervention implemented and different to conventional face to face support groups. Face to face support groups are the usual medium for patients choosing to attend a support group. The online support group will be conducted on TEAMS and moderated by Queensland Health healthcare professionals. Moderation of the online support group will be done by the research team. Allied health staff for example the renal social worker, renal psychologist, renal dietitian and renal pharmacist will be invited to join and contribute to the sessions as required and based on patient need determined through engagement with the participants during the sessions. The content of the sessions will be informal conversations. Patients will be encouraged to share experience and provide each other emotional and moral support. Support groups are an opportunity for patients to form friendships to feel less isolated. Patients will be encouraged to talk freely about their condition and share tips they have used to manage their condition.
Intervention code [1] 322330 0
Lifestyle
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329756 0
Anxiety and Depression assessed as a composite outcome using Hospital Anxiety and Depression Scale.
Timepoint [1] 329756 0
4 Weeks after commencement of group (At completion of final session).
Primary outcome [2] 329757 0
KD Quality of Life Short SF
Timepoint [2] 329757 0
4 Weeks after commencement of group (At completion of final session).
Secondary outcome [1] 403671 0
Nil
Timepoint [1] 403671 0
Nil

Eligibility
Key inclusion criteria
Patients must be on a haemodialysis treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include patients who do not wish to be included in the trial. Patients who do not have the necessary equipment and an internet connection.

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)
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This will be a very small sample sized study. The potential participant pool for the study will be 100 patients. The actual participant pool is unknown as the program will be voluntary and not all participants may choose to participate. The small sample size of the study reduces the statistical power of the study. For this reason the analysis will include paired t-tests and analysis of variance in outcome measures for individual patients and a cluster analysis to determine overall trends.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310277 0
Hospital
Name [1] 310277 0
Logan Renal Dialysis Unit
Country [1] 310277 0
Australia
Primary sponsor type
Hospital
Name
Logan Renal Dialysis Unit
Address
Cnr Loganlea and Armstrong Roads, Meadowbrook QLD 4131
Country
Australia
Secondary sponsor category [1] 311384 0
None
Name [1] 311384 0
None
Address [1] 311384 0
None
Country [1] 311384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309948 0
Metro South HREC
Ethics committee address [1] 309948 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 309948 0
Australia
Date submitted for ethics approval [1] 309948 0
02/11/2021
Approval date [1] 309948 0
29/11/2021
Ethics approval number [1] 309948 0
HREC/2021/QMS/78180

Summary
Brief summary
The intervention will be a support group conducted on TEAMs and will be a patient led group moderated by senior nursing staff. Allied health will be invited to contribute to the sessions as required and the content included in the sessions will be ascertained by engaging with patients to keep the initiative very patient focused.

The sessions will be run weekly for approximately 1 hour over the course of 4 weeks. It will be an opportunity for patients to engage with and support each other as well as a chance to engage with relevant healthcare professionals who will provide relevant support and education.

Two validated tools will used pre intervention to assess the participants anxiety and depression and quality of life. The same tools will then be used again after the 4-week intervention to reassess and provide quantitative data for the study.

The online support group will be a patient centred approach to providing self-management support. This study will look at quality of life and anxiety and depression outcomes associated with the online education and support group intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115950 0
Ms Karina Murphy
Address 115950 0
Renal Dialysis Unit, Logan Hospital, Cnr Loganlea and Armstrong Roads, Meadowbrook QLD 4131
Country 115950 0
Australia
Phone 115950 0
+61 0459899417
Fax 115950 0
+61 7 3089 2042
Email 115950 0
karina.murphy@health.qld.gov.au
Contact person for public queries
Name 115951 0
Ms Karina Murphy
Address 115951 0
Renal Dialysis Unit, Logan Hospital. Cnr Loganlea and Armstrong Roads, Meadowbrook QLD 4131
Country 115951 0
Australia
Phone 115951 0
+61 0459899417
Fax 115951 0
+61 7 3089 2042
Email 115951 0
karina.murphy@health.qld.gov.au
Contact person for scientific queries
Name 115952 0
Ms Karina Murphy
Address 115952 0
Renal Dialysis Unit, Logan Hospital. Cnr Loganlea and Armstrong Roads, Meadowbrook QLD 4131
Country 115952 0
Australia
Phone 115952 0
+61 0459899417
Fax 115952 0
+61 7 3089 2042
Email 115952 0
karina.murphy@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification; individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication for 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator. karina.murphy@health.qld.gov.au


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.