Condition category
Haematological Disorders
Date applied
28/01/2015
Date assigned
29/01/2015
Last edited
29/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anaemia is a condition where a lack of iron in the body results in a lower than usual number of red blood cells. This means that there isn't as much oxygen being delivered to the organs and tissues. This can cause a number of problems, including tiredness, breathlessness, heart palpitations and even heart failure. Anaemia is common in people with chronic kidney disease (CKD) and is associated with poor health outcomes. This study aims to develop and test a step-wise model of intervention for treating anaemia in people with CKD in primary care. It is hoped that this treatment model will improve the health of people with CKD and anaemia.

Who can participate?
General practitioners (GP) and also adult CKD patients with anaemia.

What does the study involve?
The study has two phases.
In phase 1, GPs and patients are invited to take part in group discussions in order to explore what difficulties there are in managing anaemia in CKD patients and how best to run phase 2.
In phase 2, GP practices are randomly allocated into one of two groups. Those in group 1 (usual practice), treat their patients as usual. Those in group 2 (intervention) treat their patients according to the step-wise model of intervention. This includes confirming diagnosis, taking simple steps to improve the patients’ condition (such as stopping medications that may cause bleeding), giving patients iron tablets and, if their condition warrants it, intravenous iron or erythropoiesis-stimulating agents (medication that stimulates the production of red blood cells). Health outcomes for all participants are measured at the start of the study, 6 months later and then after a year.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
GP practices in the UK

When is the study starting and how long is it expected to run for?
September 2014 to February 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Tom Chan

Trial website

http://www.clininf.eu/projects/renal-anaemia.html

Contact information

Type

Scientific

Primary contact

Dr Tom Chan

ORCID ID

Contact details

University of Surrey
School of Management
Guilford
GU2 7XH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17012

Study information

Scientific title

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

Acronym

Study hypothesis

This study aims to develop and evaluate a step-wise model of intervention for treating anaemia in people with chronic renal disease (CKD) in primary care.

Ethics approval

First MREC approval date 18/07/2014, ref: 14/LO/1185

Study design

Randomised; Interventional and Observational; Design type: Process of Care, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Primary Care; Subtopic: Other Primary Care; Disease: All Diseases

Intervention

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 interventions in CKD

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/09/2014

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 24; UK Sample Size: 24; Description: The study will recruit 4 GP practices for diagnostic analysis in Phase 1 and 20 GP practices the cluster randomised trial in Phase 2 (a total of 24 GP practices).

Participant 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).

Recruitment start date

01/09/2014

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
School of Management
Guilford
GU2 7XH
United Kingdom

Sponsor information

Organisation

Guildford and Waverley CCG

Sponsor details

Dominion House
Woodbridge Road
Guildford
GU1 4PU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes