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
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
-
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.