Development of a complex intervention for the treatment of gout in primary care
| ISRCTN | ISRCTN26368503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26368503 |
| Secondary identifying numbers | 7525 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 22/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Helen Richardson
Scientific
Scientific
Nottingham City Hospital
Academic Rheumatology
Clinical Sciences Building
Nottingham
NG5 1PB
United Kingdom
Study information
| Study design | Non-randomised observational treatment and qualitative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development of a complex intervention for the treatment of gout in primary care: a non-randomised observational treatment and qualitative study |
| Study acronym | DCI-Gout |
| Study objectives | 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(s) | Nottingham Research Ethics Committee 2 approved on the 12th October 2009 (ref: 09/H0408/94) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2010 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Key inclusion criteria | 1. Confirmed diagnosis of gout 2. SUA greater than 360 umol 3. Male and female, lower age limit of 30 years |
| Key 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) |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK) (ref: 18827)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
