Topic: Renal and Urogenital
Conditions
Interventions
Communicare: This is a self help computer package to encourage adherance to oral phosphate binders.
Dietician review: This is done in the washout period
Modified BAASIS
Sponsors
Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 30 years or above, on dialysis for at least 6 months, under the supervision of Central Manchester University Hospitals Foundation Trust (CMFT) or Salford Royal NHS Foundation Trust (SRFT) 2. Serum phosphate level of 1.8mmol/L or greater after washout (discontinuation) of previous phosphate binding medication 3. Able to achieve Renal Association standards for quality of dialysis 4. Able to communicate in English ('Communicare' package is available only in English) 5. Able to consent
Exclusion criteria
Exclusion criteria: 1. Living donor renal transplant planned in the next 12 months 2. Serum parathyroid hormone greater than 800 pg/ml (85 pmol/L)on 2 consecutive 3-monthly blood tests. Such patients probably have uncontrolled hyperparathyroidism which adversely influences serum phosphate levels, and needs treatment in its own right 3. Known intolerance of oral sevelamer and lanthanum carbonate 4. Medical history that might limit the individual's ability to take the trial treatments for the duration of the study (e.g. history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse) 5. Patients aged below 30 years have a low rate of vascular events and will not be recruited
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility; Timepoint(s): End of the study - Is a large national multi-centre RCT feasible? | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherance; Timepoint(s): End of the study 2. Consent; Timepoint(s): End of the study - Percentage Suitable Vs Percentage consented 3. Drop out rate; Timepoint(s): End of the study 4. Event rate; Timepoint(s): End of the study 5. Pill burden; Timepoint(s): End of the study 6. Renal physicians; Timepoint(s): End of the study - Percentage of renal physoicians willing to let their patients enroll 7. Suitability; Timepoint(s): Percentage of total dialysis population found suitable - End of the study 8. Target Phosphate; Timepoint(s): End of the study - Percentage who achieved target serum phosphate | — |
Countries
United Kingdom
Outcome results
None listed