Self monitoring of methotrexate by patients with arthritis

ISRCTN ISRCTN21613721
DOI https://doi.org/10.1186/ISRCTN21613721
Protocol serial number N/A
Sponsor Joint UCLH and UCL Biomedical Research Unit (United Kingdom)
Funder University College London Hospitals Charity (United Kingdom)
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

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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleSelf monitoring of treatment with methotrexate alone or in combination with anti-tumour necrosis factor alpha by patients with arthritis: a randomised controlled trial
Study objectivesTeaching 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) studiedRheumatoid and psoriatic arthritis
Intervention1. 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Methotrexate
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date01/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration150
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2010
Date of final enrolment01/06/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

City University London
London
EC1V 4PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

03/08/2020: Publication reference added.

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