Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
North West London Research Ethics Committee 1, 23/12/2009, ref: 09/H0722/91
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/02/2010
Overall trial end date
01/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/02/2010
Recruitment end date
01/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City University London
London
EC1V 4PB
United Kingdom
Sponsor information
Organisation
Joint UCLH and UCL Biomedical Research Unit (United Kingdom)
Sponsor details
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
Sponsor type
Not defined
Website
Funders
Funder type
University/education
Funder name
University College London Hospitals Charity (United Kingdom)
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26290587