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Testing a new stepwise strategy for the management of renal anaemia

Testing a new stepwise strategy for the management of renal anaemia in primary care: an exploratory cluster randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72491207
Enrollment
24
Registered
2015-01-29
Start date
2014-09-01
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care

Interventions

1. Phase 1: Systematic review. Focus Group discussions: 1.1. Practitioners groups 1.2. Patients groups Test data extraction tools & methods 2. Phase 2: Cluster randomised trial of step-wise anaemia in

Sponsors

Guildford and Waverley CCG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Phase 1: In-depth discussion Practitioners and patients from four GP practices will be invited to take part in the in-depth discussions. These four GP practices will be purposefully selected on the following criteria: 1. Achievement of Quality Outcome Framework (QOF) points for CKD 2. At least the national average of people aged over 65 years (as CKD particularly affects older people) Phase 2: Clustered Randomised Trial Practice level: 1. GP Practices should be computerised and have had the same computer system for at least 3 years; they should have had laboratory-links (ensuring completeness of pathology results) for this period; and a practice computer system using 5-byte Read codes (commonest used in UK), or Clinical Terms Version 3 (CTv3). 2. Practices have space for the review clinic and consent to participate. Patient level: 1. Adult patients registered with participating practices with CKD (stage 3 and 4) and anaemia (Hb=11g/dl), who are not under the care of a renal physician, and without an obvious other cause for their anaemia (i.e. overt cause of blood loss)

Exclusion criteria

Exclusion criteria: Practice level: 1. Practices with plans to change computer systems during the proposed 3-year study 2. Practices involved in the in-depth group discussions at Phase 1 will be excluded from taking part in Phase 2. Patient level: 1. Patient under 18 years of age 2. Those unable to consent 3. Those receiving dialysis or who have had a renal transplant 4. Those with previous adverse reaction to iron 5. Those currently or previously treated with erythropoietin 6. Those who have expressed a wish to opt out of sharing electronic records to their GP (identifiable by the present of an 'Optout Read codes’: 93C1, or 'Refused consent for upload to local shared electronic record': 9Nd1 in the GP information systems).

Design outcomes

Primary

MeasureTime frame
The proportion of people with CKD who remain anaemic one year after entry into the study

Secondary

MeasureTime frame
Feasible and acceptable step-wise model of interventions for Phase 2

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026