Self monitoring of methotrexate by patients with arthritis
| ISRCTN | ISRCTN21613721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21613721 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/11/2010
- Registration date
- 29/06/2011
- Last edited
- 03/08/2020
- 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
Prof Stanton Newman
Scientific
Scientific
Health Services Research
School of Community and Health Sciences
City University
College Building
Room A224
St John Street
London
EC1V 4PB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| 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 | Self monitoring of treatment with methotrexate alone or in combination with anti-tumour necrosis factor alpha by patients with arthritis: a randomised controlled trial |
| Study objectives | Teaching patients with arthritis how to interpret their own blood test results and appropriately initiate outpatient appointments will lead to changes in patient awareness of the role they play in their own condition compared to usual care |
| Ethics approval(s) | North West London Research Ethics Committee 1, 23/12/2009, ref: 09/H0722/91 |
| Health condition(s) or problem(s) studied | Rheumatoid and psoriatic arthritis |
| Intervention | 1. Demorgaphics (age, gender, living status, ethnicity) and clinical data (date of diagnosis, methotrexate start date, number of previous disease modifying anti-rheumatic drugs) will be collected at baseline 2. Participants will be randomised to one of two groups: 2.1. Intervention group: 2.1.1. The 2 hour self-monitoring training session will present the rationale of self-monitoring, an overview of the blood tests, physical symptoms and side-effects requiring monitoring for people taking methotrexate and a self-injected anti-TNF agent, training in how to identify normal or 'safe' ranges of blood levels, side effects and symptoms and decide, if any action is necessary 2.1.2. Intervention participants will monitor 6 consecutive blood tests which include markers of inflammation - C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), plus haemoglobin (Hb), white cell count (WCC) and liver function tests (ALP and ALT) 2.1.3. The first 3 blood tests will be monitored in collaboration with a member of the research team and the subsequent 3 independently 2.1.4. The information obtained will be used to initiate outpatient's appointments with a Rheumatology Nurse Specialist 2.2. Control group - usual care |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | The self management role and responsibility subscale of the Medication Education Impact Questionnaire, measured at baseline and again after the 3rd and 6th blood tests. |
| Secondary outcome measures | 1. Impact of Methotrexate assessed by Medication Impact Questionnaire at baseline and after 3rd and 6th blood test 2. Knowledge about Methotrexate assessed by Methotrexate in Rheumatoid Arthritis Knowledge at baseline and after 3rd and 6th blood test 3. Impact of arthritis assessed by Health Education Impact Questionnaire at baseline and after 3rd and 6th blood test 4. Mood, anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) at baseline and after 3rd and 6th blood test 5. Beliefs about arthritis assessed by Illness Perceptions Questionnaire Revised at baseline and after 3rd and 6th blood test 6. Social support at baseline and after 3rd and 6th blood test 7. Generalised Self Efficacy at baseline and after 3rd and 6th blood test 8. Beliefs about Methotrexate assessed by Beliefs about Medication Questionnaire at baseline and after 3rd and 6th blood test 9. Healthcare utilisation assessed by Treatment Burden (1-item measure) at baseline and after 3rd and 6th blood test 10. Self-reported adherence to Methotrexate Medication Adherence Report Scale at baseline and after 3rd and 6th blood test 11. Functional disability assessed by Health Assessment Questionnaire-II at baseline and after 3rd and 6th blood test 12. Pain in last 2 weeks assessed by Pain Visual Analogue Scale (VAS) (0-10) at baseline and after 3rd and 6th blood test 13. Fatigue in last 2 weeks assessed by Fatigue VAS (0-10) at baseline and after 3rd and 6th blood test 14. Disease activity (RA & PsA) assessed by Disease Acitivity Score in Rheumatoid Arthirtis-28 & Psoriatic Arthritis Response Criteria at baseline and after 6th blood test |
| Overall study start date | 01/02/2010 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. All patients with a diagnosis of Rheumatoid or Psoriatic arthritis 2. Aged 18 years or over 3. Fluency in written and spoken English 4. Patients whose treatment is classified as stable defined as those who have had disease management with methotrexate for at least 6 months, plus a further 6 months if the patient is receiving a self-injected anti-TNF agent (Adaliumab or Etanercept) |
| Key exclusion criteria | 1. Identifiable psychosis or dementia 2. Significant co-morbidity (i.e. their predominant treatment is for another illness) 3. Those whose blood tests are being monitored by their GP |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
City University London
London
EC1V 4PB
United Kingdom
EC1V 4PB
United Kingdom
Sponsor information
Joint UCLH and UCL Biomedical Research Unit (United Kingdom)
Not defined
Not defined
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
| Website | http://www.ucl.ac.uk/joint-rd-unit/ |
|---|---|
"ROR" |
https://ror.org/03r9qc142 |
Funders
Funder type
University/education
University College London Hospitals Charity (United Kingdom)
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 | 01/07/2016 | Yes | No | |
| Results article | cost-effectiveness results | 05/01/2021 | 03/08/2020 | Yes | No |
Editorial Notes
03/08/2020: Publication reference added.
