Design and protocol for the Dialysis Optimal Health Program DOHP randomised controlled trialReport as inadecuate




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Trials

, 17:447

Study protocols of trials in the Translating Research, Integrated Public Health Outcomes and Delivery TRIPOD project

Abstract

BackgroundChronic 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.

MethodsThe 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.

DiscussionWe 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.

Trial registrationANZCTR no. 12615000810516. Registered on 5 August 2015.

KeywordsDialysis Chronic kidney disease Collaborative therapy End-stage kidney disease Psychosocial health Randomised controlled trial AbbreviationsAQoL-6DAssessment of Quality of Life-6 dimensions

Brief-IPQBrief Illness Perception Questionnaire

Brief COPEabbreviated version of the COPE Inventory

CEQCredibility-Expectancy Questionnaire

CKDchronic kidney disease

CTFcollaborative therapy framework

DOHPDialysis Optimal Health Program

EMexpectation-maximization

EQ-5D-3LEuropean Quality of Life-5 dimensions-3 levels

ESKDend-stage kidney disease

GSEGeneral Self-efficacy Scale

HADSHospital Anxiety and Depression Scale

HCUQHealth Care Utilisation Questionnaire

KDQoLKidney Disease Quality of Life

MINIMini-International Neuropsychiatric Interview

MMRMmixed-effects model, repeated measures

OHPOptimal Health Program

QALYquality-adjusted life year

RCTrandomised controlled trial

TEI-SFTreatment Evaluation Inventory-Short Form

TIPITen-Item Personality Inventory

TRIPODTranslating Research, Integrated Public Health Outcomes and Delivery

WSASWork and Social Adjustment Scale

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1558-z contains supplementary material, which is available to authorized users.





Author: Simon R. Knowles - Chantal F. Ski - Robyn Langham - Emmet O’Flaherty - David R. Thompson - Susan L. Rossell - Gaye Mo

Source: https://link.springer.com/







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