Evidence map›Paper›PMID 27612446›Full record

Trial reportTrials2016

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

Simon R Knowles, Chantal F Ski, Robyn Langham, Emmet O'Flaherty, David R Thompson, Susan L Rossell, Gaye Moore, Ya-Seng Arthur Hsueh, David J Castle

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05757128 (Optimizing Mental Health for Young People at Clinical High Risk for Psychosis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05757128 nacompletednot on this mapstarted 2023, after this paper: background citation

Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

TypeinterventionalSponsorCentre for Addiction and Mental HealthRan2023 to 2024Enrolled30ConditionsPsychosis, Psychosocial FunctioningArmsOptimal Health Program
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Simon R KnowlesDepartment of Psychology, Swinburne University, Melbourne, VIC, 3122, Australia.
Chantal F SkiDepartment of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia. Chantal.Ski@acu.edu.au.
Robyn LanghamDepartment of Neurology, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
Emmet O'FlahertyDepartment of Neurology, St. Vincent's Hospital, Melbourne, VIC, 3065, Australia.
David R ThompsonDepartment of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.
Susan L RossellDepartment of Psychology, Swinburne University, Melbourne, VIC, 3122, Australia.
Gaye MooreDepartment of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.
Ya-Seng Arthur HsuehMelbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, 3010, Australia.
David J CastleDepartment of Psychiatry, The University of Melbourne, Melbourne, VIC, 3010, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: 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.

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

Indexed as

Mental HealthPeritoneal DialysisRenal DialysisAdaptation, PsychologicalClinical ProtocolsCost-Benefit AnalysisCost of IllnessHealth Care CostsHealth Knowledge, Attitudes, PracticeHumansKidney Failure, ChronicPatient-Centered CarePatient Education as TopicProgram EvaluationProspective StudiesQuality of LifeChronic kidney diseaseCollaborative therapyDialysisEnd-stage kidney diseasePsychosocial healthRandomised controlled trial

Identifiers

PMID27612446
PMCPMC5018180

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.