Early rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis, unspecified
Conditions
Interventions
Current intervention as of 04/02/2020:
The Pilot phase of the main trial will be conducted to identify whether enough eligible patients can be recruited and kept in the study then the
Sponsors
Glasgow Caledonian University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/02/2020: 1. Aged 18 years or over 2. Clinician diagnosis of RA with disease duration less than 2 years from diagnosis 3. History of disease-related foot impairments defined as at least one of: 3.1. Self-reported foot pain 3.2. Presence of foot and/or ankle joint synovitis/tenosynovitis on clinical examination since diagnosis of RA 4. Willing to participate and provide written informed consent to participate in the study 5. Sufficient English language abilities to participate in a dialogue-based intervention and undertake completion of written questionnaires. Previous inclusion criteria: 1. 18 years of age or over 2. Clinical diagnosis of RA (ACR 2010 criteria) with disease durations less than 2 years from diagnosis 3. Disease-related foot impairments defined as at least one of: self-reported foot pain, and/or the presence of foot and/or ankle joint synovitis/tenosynovitis detected during clinical examination by the rheumatologist or rheumatology nurse specialist 4. Willing to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Not able to undertake or complete the intervention (e.g. due to severe comorbid disease) identified by their consultant rheumatologist prior to screening, or the research nurse at screening 2. Unable or unwilling to provide informed consent 3. Currently taking part in other non-medical intervention studies where the goal of the intervention is to improve lower limb function and/or gait
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility phase: 1. The measurement properties (responsiveness, minimal important difference) of candidate outcome measures, to identify and select the most suitable primary outcome measure for the main trial. Measured using participant questionnaires and assessing walking capacity at 12 week follow up/visit 2 2. The acceptability of the new gait rehabilitation intervention, assessed by qualitative interviews with a subsample of participants and clinicians at 12 week follow up/visit 2 3. The safety of the new gait rehabilitation intervention, assessed by monitoring, recording and evaluating adverse effects/unintended outcomes using an adverse events reporting form as per the Glasgow CTU SOPs during each intervention session/unscheduled visit and week 12 visit 4. Participants' adherence to the new gait rehabilitation intervention and potential barriers/facilitators of adherence, assessed using Exercise Adherence Rating Scale (EARS) Questionnaire at unscheduled 12 week follow up/visit 2 5. Feasibility of participating physiotherapists and podiatrists delivering intervention as intended, assessed using semi-structured telephone-based interviews at end of feasibility phase 6. Review and refine if necessary the new gait rehabilitation intervention prior to final development of the new gait rehabilitation intervention manual and training programme for participating physiotherapists and podiatrists for the main trial. Internal pilot trial phase: 1. Sample size calculation for the main trial using the feasibility phase sample variance on the selected primary outcome 2. The feasibility of recruitment and retention of patients with early RA, including willingness to be randomised, assessed using data from pilot trial stage at the end of this phase Main trial phase:- 1. The clinical effectiveness of | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLisa Jolly
Outcome results
None listed