Condition category
Musculoskeletal Diseases
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
26/07/2016
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

Dr Alison Hammond

ORCID ID

Contact details

Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4572

Study information

Scientific title

Long term and clinical impact of the Lifestyle Management for Arthritis Programme (LMAP) for people with inflammatory arthritis

Acronym

Impact of the LMAP

Study hypothesis

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

First MREC approval date 01/02/2008, ref: 08/H0402/4

Study design

Interventional and observational single-centre treatment cohort 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 contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

17/03/2008

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 293; UK Sample Size: 293

Participant exclusion criteria

Study 1:
Past participants considered no longer well enough to participate by their Consultant.

Study 2:
Does not meet inclusion criteria

Recruitment start date

17/03/2008

Recruitment end date

28/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rehabilitation and Human Performance Research
Salford
M6 6PU
United Kingdom

Sponsor information

Organisation

Royal Derby Hospital (UK)

Sponsor details

Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.derbyhospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (ARC) (UK)

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

Publication citations

Additional files

Editorial Notes

26/07/2016: No publications found, verifying study status with principal investigator.