Condition category
Musculoskeletal Diseases
Date applied
18/11/2010
Date assigned
29/06/2011
Last edited
21/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stanton Newman

ORCID ID

Contact details

Health Services Research
School of Community and Health Sciences
City University
College Building
Room A224
St John Street
London
EC1V 4PB
United Kingdom

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 measures

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

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

http://www.ucl.ac.uk/joint-rd-unit/

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26290587

Publication citations

Additional files

Editorial Notes