Supporting Adults with Chronic Kidney Disease to engage in shared decision making successfully (SUCCESS)
The University of SydneyDataset description
This dataset will include up to 384 participants receiving in-center or home-based hemodialysis or peritoneal dialysis recruited from six local health districts in the Greater Sydney region, New South Wales, Australia. Baseline data will include demographics, dialysis history, cognitive status, health literacy and self-efficacy scores. Follow-up data will be collected at 3, 6 and 12 months and will include patient reported outcomes (quality of life, knowledge, confidence, health behaviour and self-management) and clinical outcomes (symptom burden (Palliative care Outcome Scale) and nutritional status (Patient-generated Subjective Global Assessment).Identifiers
Source Study
Trial name (public)
Supporting Adults with Chronic Kidney Disease to engage in shared decision making successfully (SUCCESS): A Pragmatic randomised controlled trial of the SUCCESS intervention.Trial acronym
SUCCESS
Trial ID
ACTRN12621000235808
Purpose
Educational / counselling / training
Phase
Not Applicable
Funding
Government body,NSW Ministry of Health
Scientific enquiries
Dr Danielle Muscat
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, an .... Read more
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.
Key Exclusion Criteria
1. Unable to provide informed consent 2. Under 18 years
Can healthy volunteers participate?
No
Population
Sample Size 384
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Chronic Kidney Disease
Condition code Renal and Urogenital
Intervention
Intervention code Treatment: Other
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 ap .... Read more
Comparison
Control group Active
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.
Outcomes
Outcome: Shared decision making assessed using the Decision Self Efficacy Scale Timepoint: At 0, 3, 6 (primary endpoint) and 12 months of app usage
Outcome: Health Literacy assessed using Health Literacy Questionnaire 0, 3, 6 (primary endpoint) and 12 months. Timepoint: At 0, 3, 6 (primary endpoint) and 12 months of app usage
Outcome: Rate of unscheduled health encounters reported by participants at follow up visits.. Timepoint: At 3, 6 (primary endpoint) and 12 months of app usage.