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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN38137821 |
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Date of registration:
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12/09/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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Date of first enrolment:
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04/11/2002 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN38137821 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dawn
Yokum |
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Address:
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Department of Nutrition & Dietetics
59 Philpot Street
The Royal London Hospital
Whitechapel
E1 1BB
London
United Kingdom |
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Telephone:
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+44 020 7377 7735 |
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Email:
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dawn.yokum@bartsandthelondon.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Urological and Genital Diseases: Haemodialysis
Urological and Genital Diseases
Haemodialysis
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Intervention(s)
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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.
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Primary Outcome(s)
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Group 1 (both interventions): results for phosphate knowledge and serum phosphate control should be the best out of all the groups
Groups 2 + 3 (each had one intervention only, group teaching session and intensive clinic respectively): results for phosphate knowledge and serum phosphate control should improve versus baseline
Group 4 (control): results for phosphate knowledge and serum phosphate control should be similar to baseline
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0205118456
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Source(s) of Monetary Support
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Barts and The London NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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