Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
22/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Christina Karamanidou

ORCID ID

Contact details

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
+44 (0)20 7188 7188

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes