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ISRCTN
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ISRCTN35452453
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ClinicalTrials.gov identifier
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Public title
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Exploring end stage renal disease patients' beliefs about phosphate binding medication and intervening to improve their adherence.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013146110
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Study hypothesis
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Initially, a small pilot study of qualitative design will be carried out. The aim of this first part of the study will be to explore renal patients' concept of the mechanisms by which phosphate binding medication works and how this type of medication should be used. During the second stage, an intervention targeting patients' non-adherence with phosphate binding medication undergoing renal replacement therapy will be implemented. The intervention will be psycho educational and have as an aim to assist patients to change treatment related beliefs important in shaping medication adherence behaviour.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases: Renal disease
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Participants - inclusion criteria
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Approx. 90 (10 for the qualitative study and 80 for the intervention) patients will be recruited from the Renal Unit at Guy's Hospital. Patients asked to participate will be kidney failure patients on renal replacement therapy (haemodialysis). For patients to be included in the study, they have to be undergoing dialysis for at least six months and be on phosphate binding medication.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/12/2003
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Anticipated end date
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01/06/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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90
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Interventions
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An interview schedule will provide the framework for the semi-structured interviews conducted for the purpose of the first part of the study. The intervention will involve a demonstration of mixing a solution of phosphate binding medication in a phosphate solution with an accompanying explanation of how this treatment is beneficial to renal patients. A randomised controlled trial design will be followed with patients being allocated to receive either the intervention or treatment as usual. Phosphate levels will be obtained via the patients' notes, together with other outcome measures. These will be analysed and compared with the baseline measures previously recorded so that the effectiveness of the intervention in terms of improving adherence can be evaluated.
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Primary outcome measure(s)
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Laboratory blood measurements obtained from patient notes at baseline and at 3-month follow up will serve as outcome measures together with measures such as patients' satisfaction with information regarding this treatment and understanding of the nature of treatment.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK)
Own account
NHS R&D Support Funding
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18302808
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Contact name
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Miss
Christina
Karamanidou
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Address
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Guy's & St Thomas' NHS Foundation Trust
Psychology Unit
5th Floor, Thomas' Guy House
Guy's Campus, St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 7188
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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22/07/2009
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Date ISRCTN assigned
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30/09/2005
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