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 |
| Protocol serial number | N0013146110 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Guy's & St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
