Exploring end stage renal disease patients' beliefs about phosphate binding medication and intervening to improve their adherence.

ISRCTN	ISRCTN35452453
DOI	https://doi.org/10.1186/ISRCTN35452453
Secondary identifying numbers	N0013146110

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 22/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Christina Karamanidou
Scientific

Guy's & St Thomas' NHS Foundation Trust
Psychology Unit
5th Floor, Thomas' Guy House
Guy's Campus, St Thomas' Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 7188

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2003
Completion date	01/06/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	90
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2003
Date of final enrolment	01/06/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's & St Thomas' NHS Foundation Trust

London
SE1 9RT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Guy's and St. Thomas' NHS Foundation Trust (UK)

No information available

Own account

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008		Yes	No