Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 5, 2022
Date Accepted: Jun 28, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of the SUCCESS health literacy app for Australian adults with chronic kidney disease: Study protocol for a pragmatic randomised controlled trial
ABSTRACT
Background:
We developed a smartphone app (the SUCCESS app) to support Australian adults with kidney failure undertaking dialysis to actively participate in self-management and decision making. The content of the SUCCESS app was informed by a theoretical model of health literacy which recognizes the importance of reducing the complexity of health information as well as providing skills necessary to access, understand and act on this information.
Objective:
The purpose of this study is to investigate the efficacy of the SUCCESS app intervention.
Methods:
We designed a multi-centre pragmatic randomised control trial to compare the SUCCESS app plus usual care (intervention) to usual care alone. 384 participants receiving in-centre or home-based haemodialysis or peritoneal dialysis will be recruited from six Local Health Districts in the Greater Sydney region, New South Wales, Australia. To avoid intervention contamination, a pragmatic randomisation approach will be used for those dialysing in-centre, in which randomization will be based on the days of receiving haemodialysis and by centre (Mon-Wed-Fri or Tues-Thurs-Sat). Home-based participants will be individually randomised centrally using simple randomization and two stratification factors: language spoken at home and research site. Consenting participants will be invited to use the SUCCESS app for 12 months. The primary endpoints - assessed after 3, 6, 12 months of app usage - are health literacy skills (evaluated using the Health Literacy Questionnaire), decision self-efficacy (Decision Self-Efficacy Scale), and rates of unscheduled health encounters. Secondary outcomes include patient reported (quality of life [EQ-5D-5L], knowledge, confidence, health behaviour and self-management) and clinical outcomes (symptom burden [POS-Renal], nutritional status [Patient Generated Subjective Global Assessment] and intradialytic weight gain). App engagement will be determined via app analytics. All analyses will be undertaken using an intention-to-treat approach comparing the intervention and usual care arms.
Results:
The study has been approved by Nepean Blue Mountains Human Research Ethics Committee (2020/ETH00910) and recruitment has begun at nine sites. We expect to finalize data gathering by 2023 and publish the manuscript by 2024.
Conclusions:
Enhancing health literacy skills for haemodialysis patients is an important endeavour given the association between poor health literacy and poor health outcomes, especially among culturally-diverse groups. The findings from this trial will be published in peer-reviewed journals and disseminated through conferences and updates with partners including participating local health districts, Kidney Health Australia and consumers. The SUCCESS app will continue to be available to all participants following trial completion. Clinical Trial: ACTRN 12621000235808
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.