Long term and clinical impact of the Lifestyle Management for Arthritis Programme (LMAP) for people with inflammatory arthritis
| ISRCTN | ISRCTN61657013 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61657013 |
| Secondary identifying numbers | 4572 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 26/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alison Hammond
Scientific
Scientific
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom
Study information
| Study design | Interventional and observational single-centre treatment cohort 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 contact details to request a participant information sheet |
| Scientific title | Long term and clinical impact of the Lifestyle Management for Arthritis Programme (LMAP) for people with inflammatory arthritis |
| Study acronym | Impact of the LMAP |
| Study objectives | There have been few long-term evaluations of health profession-led arthritis education programmes' (AEPs) impact on the health status of people with inflammatory arthritis. A randomised controlled trial (n = 167) of a modular group programme (the Lifestyle Management for Arthritis Programme [LMAP]) versus an information-based group AEP similar to typical UK practice identified, at 12-month follow-up, that the LMAP was significantly more effective in reducing pain and improving self-efficacy. The LMAP continues to run as part of our service delivery. We aim to investigate, using postal questionnaires: 1. The longer-term (6 year) effects of the LMAP and typical AEP on health status by following up trial participants 2. Investigate LMAP effectiveness in an uncontrolled setting in a 6 and 12 month observational study (n = 126) 3. Investigate participants' views of the LMAP using individual semi-structured interviews Results will be analysed to evaluate effects on adherence with health behaviours, pain, self-efficacy and functional, physical, psychological and disease status. |
| Ethics approval(s) | First MREC approval date 01/02/2008, ref: 08/H0402/4 |
| Health condition(s) or problem(s) studied | Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Intervention | Study 1: a long-term (6y) follow up of a previous clinical trial. Patients were randomised to receive the LMAP education programme or a standard arthritis education programme. The LMAP consists of 9 x 2.5 h group meetings: a first module of 4 meetings, a second module of 4 meetings approx. 3 months later and a final review or "booster meeting" 2 - 3 months later. Module 1 "Looking After Your Joints"consists of: information about arthritis and potential consequences, ergonomic approaches. Follow Up Length: 12 month(s) Study Entry: Registration only |
| Intervention type | Behavioural |
| Primary outcome measure | Pain using a 10 cm visual analgue scale (0 = no pain; 10 = pain as bad as it can be). Study 1: 6 years |
| Secondary outcome measures | Study 1: All measurements at 6 year follow-up Study 2: all measurements at 0, 6 and 12 months |
| Overall study start date | 17/03/2008 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 293; UK Sample Size: 293 |
| Key inclusion criteria | Study 1: Past participants of RCT evaluating the LMAP. Study 2: 1. Patients aged over 18 years 2. Diagnosis of either rheumatoid arthritis, inflammatory arthritis or psoriatic arthritis, confirmed by a consultant rheumatologist 3. Referred by a member of the rheumatology multi-disciplinary team as suitable for the education programme |
| Key exclusion criteria | Study 1: Past participants considered no longer well enough to participate by their Consultant. Study 2: Does not meet inclusion criteria |
| Date of first enrolment | 17/03/2008 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Rehabilitation and Human Performance Research
Salford
M6 6PU
United Kingdom
M6 6PU
United Kingdom
Sponsor information
Royal Derby Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Website | http://www.derbyhospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/005r9p256 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK)
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 |
Editorial Notes
26/07/2016: No publications found, verifying study status with principal investigator.
