A randomised controlled two part study to evaluate the effectiveness of different education methods to achieve serum phosphate levels set by the Renal Association for haemodialysis patients.
| ISRCTN | ISRCTN38137821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38137821 |
| Protocol serial number | N0205118456 |
| Sponsor | Department of Health (UK) |
| Funder | Barts and The London NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 29/04/2010
- 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 Dawn Yokum
Scientific
Scientific
Department of Nutrition & Dietetics
59 Philpot Street
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 020 7377 7735 |
|---|---|
| dawn.yokum@bartsandthelondon.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To achieve good serum phosphate control in haemodialysis patients compliance with a phosphate restricted diet and phosphate binder medication is important. The aim of this project is to evaluate the effectiveness of different education methods including group teaching sessions and intensive phosphate clinics. We hope to find the best methods of educating people to achieve the desired levels. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Haemodialysis |
| Intervention | 68 patients will be recruited and randomised into 4 groups. Baseline data on their phosphate knowledge and routine blood chemistry will be obtained. Two groups will attend group education sessions run by the renal dietician and the renal pharmacist. The other two groups will act as controls. At the end of this phase the phosphate questionnaire will be repeated and blood will be taken for analysis. The patients will then complete a 1 month wash-out phase. At the end of this they will repeat the questionnaire and have blood taken. Two groups will attend monthly intensive phosphate clinics for a 4 month period. The other two groups will act as controls. The questionnaire and blood test will be repeated at the end of this phase which is also the end of the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Group 1 (both interventions): results for phosphate knowledge and serum phosphate control should be the best out of all the groups |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 04/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 68 |
| Key inclusion criteria | Patients will be recruited from Barts and The London NHS Trust haemodialysis population. This includes hospital and satellite units. Inclusion criteria: 1. Serum phosphate: >1.7 mmol/l 2. Serum calcium: 2.2 - 2.6 mmol/l 3. Serum parathyroid hormone (PTH): 10-50 pmol. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/11/2002 |
| Date of final enrolment | 04/11/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Nutrition & Dietetics
London
E1 1BB
United Kingdom
E1 1BB
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 | 01/11/2008 | Yes | No |
