A feasibility study to inform the design of a national multi-centre RCT to evaluate if reducing serum phosphate to normal levels improves clinical outcomes including mortality, cardiovascular events, bone pain or fracture in patients on dialysis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: 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: This is a questionnaire which is administered every 4 weeks in the study to encourage adherence Oral phosphate binders: These are Lanthanum and Sevelamer. They are normally used as part of routine clinical care in dialysis patients. PDSI: Pittsborough Dialysis Symptom Index ‐ This is a symptom score which is administered at 3 time points in the study. CONDITION: Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal ; Urological and Genital Diseases PRIMARY OUTCOME: Feasibility; Timepoint(s): End of the study ‐ Is a large national multi‐centre RCT feasible? SECONDARY OUTCOME: 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 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
Epistemonikos ID: 9abeb09c2072d9036199506162422260f14dd836
First added on: Aug 23, 2024