Inflammatory rheumatological disorders: rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), polymyalgia rheumatica (PMR) or giant cell arteritis (GCA) Musculoskeletal Diseases
Conditions
Interventions
Participating GP practices are randomly allocated to one of two groups:
1. Intervention practices: in addition to best current standard care, participants are offered a 30-minute nurse-led integrated
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. GP Read code for any of the following conditions - rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), polymyalgia rheumatica (PMR) or giant cell arteritis (GCA) 3. Registered with a participating GP practice 4. Ability to understand and capable of giving written informed consent in English
Exclusion criteria
Exclusion criteria: 1. Vulnerable patients (e.g. patients on the practice register for severe enduring mental ill health (such as unstable schizophrenia / bipolar disorder), significant cognitive impairment (such as dementia) and/or terminal illness 2. Those that reside in a nursing home (as care pathways are different)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of recruitment, retention and acceptability of the INCLUDE intervention To help identify the most appropriate measure for a main trial, this pilot will use the three measures below to assess the feasibility and acceptability of the INCLUDE intervention: 1. Patient Activation Measure (Hibberd at al, 2005) via postal questionnaires at 0 and 6 months 2. Bristol Multi-morbidity Treatment Burden Questionnaire (Salisbury & Duncan, 2017) via postal questionnaires at 0, 3 and 6 months 3. Treatment Acceptability and Credibility (Borkovec & Nau, 1972) via postal questionnaire at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be assessed for their feasibility: 1. Response rate of general practices to participate in the trial 2. Proportion of patients with a code for one of the five conditions who are eligible for inclusion into the trial 3. Overall recruitment to the trial 4. Follow-up rates at 6 months, overall and per arm 5. Completion rates of the INCLUDE computer template and the self-reported outcome measures* 6. Acceptability of the integrated care review from the perspectives of practitioners and patients participating in review (qualitative study) *Self-report outcome measures are as follows: 1. Pain is measured using the Numerical Rating Scale (0-10) via postal questionnaires at 0, 3 and 6 months 2. Self efficacy is measured using the Self-Efficacy for Managing Chronic Disease measure via postal questionnaires at 0 and 6 months 3. GP practice service provision is measured using the General Practice Assessment Questionnaire (GPAQ, National Primary Care Research and Development Centre, University of Manchester and Safran/NEMCH) via postal questionnaire at 3 months 4. Quality of life is measured using EQ-5D-5L (Herdman et al., 2011) via postal questionnaires at 0, 3 and 6 months 5. Physical function is measured using the Modified Health Assessment Questionnaire MHAQ (Maska et al., 2011) via postal questionnaires at 0 and 6 months 6. Fatigue is measured using the Modified Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue (Cella et al., 2002) via postal questionnaires at 0 and 6 months 7. Anxiety is measured using the Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer et al., 2006) via postal questionnaires at 0 and 6 months 8. Depression is measured using the Modified Patient Health Questionnaire (PHQ-8) (Kroenke, 2001) via postal questionnaires at 0 and 6 months | — |
Countries
United Kingdom
Contacts
Public ContactKendra Cooke
Outcome results
None listed