Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000235808
Ethics application status
Approved
Date submitted
19/10/2020
Date registered
5/03/2021
Date last updated
5/03/2021
Date data sharing statement initially provided
5/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting Adults with Chronic Kidney Disease to engage in shared decision making successfully (SUCCESS): A Pragmatic randomised controlled trial of the SUCCESS intervention.
Scientific title
Supporting Adults with Chronic Kidney Disease to engage in shared decision making successfully (SUCCESS): A Pragmatic randomised controlled trial of the SUCCESS intervention.
Secondary ID [1] 302544 0
None
Universal Trial Number (UTN)
Trial acronym
SUCCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 319413 0
Condition category
Condition code
Renal and Urogenital 317387 317387 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: This is a multi-centre pragmatic randomized controlled trial with 0, 3, 6 and 12 month data collection points; both quantitative and qualitative methods will be used.

Population: The study population consists of adults with Stage 5 chronic kidney disease who are currently receiving in-centre or home-based haemodialysis or peritoneal dialysis.

Intervention: Participants who are randomized to the intervention will be invited to use the SUCCESS app for a maximum of 12 months. The SUCCESS app was designed to include informational content, covering diet, fluids, medicine, physical activity, emotional wellbeing and supportive care. Furthermore, the SUCCESS app includes features to improve the communicative and critical health literacy skills of patients across four domains: skills to a) access, b) understand, c) appraise and d) use/act on health information to make health decisions and be involved in self-management. Participants will be instructed to engage with the SUCCESS app as often as they would like. App analytics will be used the monitor the usage patterns of the app.
Intervention code [1] 318831 0
Treatment: Other
Comparator / control treatment
The control group will be people with chronic kidney disease receiving standard care. That is patient currently receiving haemodialysis at an in-patient or outpatient dialysis centre, home-based haemodialysis or peritoneal dialysis.
Control group
Active

Outcomes
Primary outcome [1] 325424 0
Shared decision making assessed using the Decision Self Efficacy Scale
Timepoint [1] 325424 0
At 0, 3, 6 (primary endpoint) and 12 months of app usage
Primary outcome [2] 325773 0
Health Literacy assessed using Health Literacy Questionnaire 0, 3, 6 (primary endpoint) and 12 months.
Timepoint [2] 325773 0
At 0, 3, 6 (primary endpoint) and 12 months of app usage
Primary outcome [3] 326003 0
Rate of unscheduled health encounters reported by participants at follow up visits..
Timepoint [3] 326003 0
At 3, 6 (primary endpoint) and 12 months of app usage.
Secondary outcome [1] 387903 0
Quality of Life assessed using the EQ5D-5L (Primary Outcome)
Timepoint [1] 387903 0
At 3, 6 (Primary endpoint) and 12 months of app usage.
Secondary outcome [2] 389831 0
Changes in symptom burden assessed using the Palliative care Outcome Scale (Renal) (Primary Outcome)
Timepoint [2] 389831 0
At 3, 6 (Primary Endpoint) and 12 months of app usage.
Secondary outcome [3] 389832 0
Knowledge assessed using a a Knowledge questionnaire purpose-designed
Timepoint [3] 389832 0
At 3, 6 and 12 months of app usage.
Secondary outcome [4] 391418 0
Confidence assessed using a purpose-designed questionnaire
Timepoint [4] 391418 0
At 3, 6, and 12 months of app usage.
Secondary outcome [5] 391419 0
Averaged interdialytic weight change assessed using digital scales
Timepoint [5] 391419 0
At 3, 6, and 12 months of app usage.
Secondary outcome [6] 391420 0
Behaviour and behavioural intentions assessed by theory-informed behaviour and intentions questions.
Timepoint [6] 391420 0
At 3, 6 and 12 months of app usage.
Secondary outcome [7] 391421 0
Health service utilisation assessed by self-report at follow up visits.
Timepoint [7] 391421 0
At 3, 6 and 12 months of app usage.

Eligibility
Key inclusion criteria
1. Stage 5 chronic kidney disease
2. Currently receiving haemodialysis at an in-patient or outpatient renal dialysis centre, home-based haemodialysis or peritoneal dialysis
3. Ability to read and speak English sufficiently well to respond to written questions without assistance
4 Ability to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent
2. Under 18 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants dialysis at home will be randomised centrally using simple randomisation. t is not feasible to randomise patients individually when attending in-centre dialysis given likely intervention contamination (where the intervention is experienced by controls as well as those allocated the intervention) when control and intervention participants dialyse in the same room three times each week for several hours. However, in-centre patients always attend on the same days; patients either dialyse on Monday, Wednesday and Friday (MWF) or Tuesday, Thursday and Saturday (TTS). We will therefore use a pragmatic approach by randomising the pattern of attendance, not the patient; by centre, all participants attending MWF would be randomly assigned to the SUCCESS intervention, or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An interactive Voice Response System will be used for randomization.. Participants will be randomized using minimization and 2 stratification factors, including: language spoken at home and research site.
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
All analyses will be by intention-to-treat comparing the intervention and usual-care arms. For continuous and binary outcomes, linear and logistic regression models will be used respectively, with the study arm as a covariate. All models will also be adjusted for centre using a random effect and both type of patient (home-based or in-centre), and dialysis-schedule will be adjusted for using fixed effects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/12/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
384
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17823 0
Westmead Hospital - Westmead
Recruitment hospital [2] 17824 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [3] 17826 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 17827 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 17828 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 17829 0
Concord Repatriation Hospital - Concord
Recruitment hospital [7] 17830 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 17831 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 31679 0
2145 - Westmead
Recruitment postcode(s) [2] 31680 0
2144 - Auburn
Recruitment postcode(s) [3] 31682 0
2148 - Blacktown
Recruitment postcode(s) [4] 31683 0
2747 - Kingswood
Recruitment postcode(s) [5] 31684 0
2065 - St Leonards
Recruitment postcode(s) [6] 31685 0
2139 - Concord
Recruitment postcode(s) [7] 31686 0
2170 - Liverpool
Recruitment postcode(s) [8] 31687 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 306980 0
Government body
Name [1] 306980 0
NSW Ministry of Health
Country [1] 306980 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Public Health, Edward Ford Building, A27 Fisher Rd, University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 307545 0
None
Name [1] 307545 0
None
Address [1] 307545 0
Country [1] 307545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307112 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 307112 0
2-6 Station Street, Penrith NSW 2750, Australia
Ethics committee country [1] 307112 0
Australia
Date submitted for ethics approval [1] 307112 0
17/04/2020
Approval date [1] 307112 0
22/06/2020
Ethics approval number [1] 307112 0

Summary
Brief summary
We have developed a smartphone App to support participation in decision-making for adults with stage 5 chronic kidney disease who are currently receiving haemodialysis. The App is called the SUCCESS App. It includes information about:
• Diet
• Fluids
• Physical activity
• Medicines
• Emotional wellbeing
• Supportive care
• Health literacy skills
The purpose of this study is to investigate whether the SUCCESS App supports adults with chronic kidney disease to make decisions about their health, and helps increase knowledge, skills and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106074 0
Dr Danielle Muscat
Address 106074 0
The University of Sydney - School of Public Health
Edward Ford Building, A27 Fisher Road, University of Sydney, NSW 2006
Country 106074 0
Australia
Phone 106074 0
+61 2 9351 7819
Fax 106074 0
Email 106074 0
[email protected]
Contact person for public queries
Name 106075 0
Mrs Jennifer Isautier
Address 106075 0
Edward Ford Building, A27 Fisher Road, University of Sydney, NSW 2006
Country 106075 0
Australia
Phone 106075 0
+61291142199
Fax 106075 0
Email 106075 0
[email protected]
Contact person for scientific queries
Name 106076 0
Dr Danielle Muscat
Address 106076 0
The University of Sydney - School of Public Health
Edward Ford Building, A27 Fisher Road, University of Sydney, NSW 2006
Country 106076 0
Australia
Phone 106076 0
+61 2 9351 7819
Fax 106076 0
Email 106076 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
This is being discussed by the Clinical Trial steering committee and investigators, we are currently discussing the feasibility for data sharing.


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.