Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013146110
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Urological and Genital Diseases: Renal disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2003
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
90
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2003
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's & St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18302808
Publication citations
-
Results
Karamanidou C, Weinman J, Horne R, Improving haemodialysis patients' understanding of phosphate-binding medication: a pilot study of a psycho-educational intervention designed to change patients' perceptions of the problem and treatment., Br J Health Psychol, 2008, 13, Pt 2, 205-214, doi: 10.1348/135910708X288792.