Condition category
Musculoskeletal Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Helen Richardson

ORCID ID

Contact details

Nottingham City Hospital
Academic Rheumatology
Clinical Sciences Building
Nottingham
NG5 1PB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7525

Study information

Scientific title

Development of a complex intervention for the treatment of gout in primary care: a non-randomised observational treatment and qualitative study

Acronym

DCI-Gout

Study hypothesis

Phase 1 contains the development and feasibility work that is required prior to the community based RCT:
1. To develop a practical and acceptable nurse-led complex intervention for gout
2. To explore the potential barriers to such an intervention and adapt the intervention for optimial effectiveness
3. Address the following question: given optimal circumstances (i.e., a dedicated expert gout clinic), can application of the key component of the current management guidelines achieve the therapeutic target (serum uric acid [SUA] less than 360 umol/L)?

To identify possible barriers to the delivery of, and adherence to the intervention, indepth interviews will be arranged with 12 participants with gout, GPs and practices nurses. In addition, 6 GPs and 6 practice nurses will also be invited to participate in a focus group.

Ethics approval

Nottingham Research Ethics Committee 2 approved on the 12th October 2009 (ref: 09/H0408/94)

Study design

Non-randomised observational treatment and qualitative study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases

Intervention

Interventions will be based on the key elements of high quality gout management included in the EULAR and BSR guidelines. Following clinical assessment, study participants will be advised with respect to lifestyle modifications and, if relevant, will be prescribed licensed serum uric acid lowering medication (e.g., Allopurinol). The medication, dose and frequency will be dependent up on individual requirements. The number of attendances will also be based on the individual's clinical requirements.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Serum uric acid reduced to below 360 umol/L at 12 months

Secondary outcome measures

Clinical outcomes such as frequency of acute attacks and number and size of tophi will be recorded

Overall trial start date

01/02/2010

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of gout
2. SUA greater than 360 umol
3. Male and female, lower age limit of 30 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

Gout cases with a SUA less than 360 umol/L (GPs asked not to contact patients with terminal illness or severe mental illness and those unable to give informed consent)

Recruitment start date

01/02/2010

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (ARC) (UK) (ref: 18827)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22679303

Publication citations

  1. Results

    Rees F, Jenkins W, Doherty M, Patients with gout adhere to curative treatment if informed appropriately: proof-of-concept observational study., Ann. Rheum. Dis., 2013, 72, 6, 826-830, doi: 10.1136/annrheumdis-2012-201676.

Additional files

Editorial Notes