Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.
Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis.



The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points.



We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community support. The outcomes associated with this study are significant in terms of enhancing an at-risk population's psychosocial health and reducing treatment-related costs and associated pressures on the healthcare system.



ANZCTR no. 12615000810516 . Registered on 5 August 2015.
Department of Psychology, Swinburne University, Melbourne, VIC, 3122, Australia.|Department of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.|Mental Health Service, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Simon R
SR
Knowles
Department of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia. Chantal.Ski@acu.edu.au.|Mental Health Service, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia. Chantal.Ski@acu.edu.au.|Centre for the Heart and Mind, Australian Catholic University, Melbourne, VIC, 3000, Australia. Chantal.Ski@acu.edu.au.
Chantal F
CF
Ski
Department of Neurology, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Robyn
R
Langham
Department of Neurology, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Emmet
E
O'Flaherty
Department of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.|Centre for the Heart and Mind, Australian Catholic University, Melbourne, VIC, 3000, Australia.
David R
DR
Thompson
Department of Psychology, Swinburne University, Melbourne, VIC, 3122, Australia.|Mental Health Service, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Susan L
SL
Rossell
Department of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.|Mental Health Service, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Gaye
G
Moore
Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, 3010, Australia.
Ya-Seng Arthur
YS
Hsueh
Department of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.|Mental Health Service, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.|Centre for the Heart and Mind, Australian Catholic University, Melbourne, VIC, 3000, Australia.
David J
DJ
Castle
D000223:Adaptation, Psychological; D002985:Clinical Protocols; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D008603:Mental Health; D010353:Patient Education as Topic; D018802:Patient-Centered Care / Q000191:economics / Q000379:methods*; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000191:economics; D015397:Program Evaluation; D011446:Prospective Studies; D011788:Quality of Life; D006435:Renal Dialysis / Q000009:adverse effects / Q000191:economics; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D020377:Self Efficacy; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
Chronic kidney disease; Collaborative therapy; Dialysis; End-stage kidney disease; Psychosocial health; Randomised controlled trial