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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN51523281 |
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Date of registration:
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21/01/2011 |
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Primary sponsor: |
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Public title:
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A study evaluating the effect of Educational Needs Assessment Tool (ENAT) focused patient education, on health outcomes in patients with rheumatoid arthritis
The ENAT study |
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Scientific title:
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A multicentre randomised controlled interventional process of care study evaluating the effect of Educational Needs Assessment Tool (ENAT) focused patient education, on health outcomes in patients with rheumatoid arthritis |
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Date of first enrolment:
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Jun 1 2010 |
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Target sample size:
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Planned sample size: 130; UK sample size: 130 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN51523281 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised controlled interventional process of care trial
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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A
Adebajo |
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Address:
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Pogmoor Road
S75 2EP
Barnsley
United Kingdom |
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Telephone:
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Email:
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aadebajo@nhs.net |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Positive diagnosis of rheumatoid arthritis defined by the American Rheumatism Association (ARA) criteria
2. Aged 18 years or above, either sex
3. Ability to complete questionnaires unaided
Exclusion criteria: Patients with a history of severe mental health problems which would impair their ability to provide informed consent should be excluded
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
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Intervention(s)
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130 RA patients will be randomised into an Experimental Group (EG) or Control Group (CG).
The EG will complete the ENAT priot to seeing a Clinical Nurse Specialist (CNS) at weeks 0, 16 and 32. For the EG, the CNS will use the ENAT as a template to meet the patients perceived educational needs in addition to usual care. The CG will receive their usual care from the CNS without the aid of the ENAT.
Study entry: single randomisation only.
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Primary Outcome(s)
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To evaluate the effectiveness of ENAT focused patient education on health outcomes of RA patients, measured at baseline, 16 weeks and 32 weeks.
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Secondary Outcome(s)
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1. To establish whether the patients perceive they are getting an equally good or inadequate education
2. To evaluate the usability of the ENAT in a clinical setting
Measured at baseline, 16 weeks and 32 weeks.
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Source(s) of Monetary Support
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National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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