Condition category
Musculoskeletal Diseases
Date applied
21/01/2011
Date assigned
21/01/2011
Last edited
22/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A research review about outcomes for patients with rheumatoid arthritis has questioned patient education and its effects, claiming that any benefits patients gain are small and short lived. This begs the question 'is time spent by health professionals giving patient education good value?' It has been suggested that one reason the research review found little evidence to support patient education is that patients and health professionals have different views about the kind of education that should be given and the best time to give/receive it. Another reason suggested for the lack of good outcomes is that the measurements used to test research outcomes have not been the best ones or the most appropriate to use. The ENAT questionnaire was developed for this reason. Our research looked at whether the patients who have education based on the ENAT patient-completed questionnaire received more suitable education by the Clinical Nurse Specialist, show better health outcomes, and have more long-term health benefits than those who did not use the ENAT.

Who can participate?
Patients aged 18 years or over diagnosed with rheumatoid arthritis.

What does the study involve?
Patients were randomly allocated into two groups. One group received and completed the ENAT and this was used as a guide by the Rheumatology Nurse to provide patient education in addition to the patients' usual care. The second group received usual care from the same nurse. Both groups completed three other validated and reliable health assessment questionnaires which were used to assess their outcomes. Sixteen patients from two hospitals and four nurses from three hospitals were invited to be interviewed to find out their view on using the ENAT.

What are the possible benefits and risks of participating?
We cannot promise that the study will benefit you. Future patients may benefit from the knowledge gained in this study. The use of an easily completed and quick to use questionnaire would benefit patients and practitioners. It would enable pracititioners to provide patients with the information that they need to self care effectively at the time they need it in a speedy and structured format.There are no identifiable risks or disadvantages in taking part in this study. The only minor burden may be for those participants who are chosen for the interviews will have to attend an extra hospital visit.

Where is the study run from?
Barnsley Hospital (UK).

When is the study starting and how long is it expected to run for?
June 2010 to March 2012.

Who is funding the study?
National Institute of Health Research (NIHR) (UK).

Who is the main contact?
Dr A Adebajo
aadebajo@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Adebajo

ORCID ID

Contact details

Pogmoor Road
Barnsley
S75 2EP
United Kingdom
-
aadebajo@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9230

Study information

Scientific title

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

Acronym

ENAT

Study hypothesis

The study hypothesis is that 'the use of the Educational Needs Assessment Tool (ENAT) to determine the educational needs of rheumatoid arthritis (RA) patients will lead to improved outcomes, and demonstrate long term benefits'. The study will look at whether the patients who are given education based on a patient-completed questionnaire called the ENAT, get more relevant education, show better health outcomes and have more long-term health benefits than those who do not use the ENAT. 130 RA patients will be randomised into an Experimental Group (EG) or Control Group (CG). The EG will complete the ENAT prior 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.

The primary patient outcome will be change in self efficacy. Secondary measures comprise physical function, psychological status, pain, social interaction and knowledge of disease. To determine the ENAT's usability within the practice setting, semi-structured qualitative interviews will take place with the practitioners and a purposive sample of patients. They will be selected to represent a range of age, gender, disease activity, disease duration and level of general education. Randomisation will be completed by a Research Associate who will have the randomisation codes. The Project Coordinator will be blinded as to who receives the ENAT. Randomisation to take place in the Rheumatology Outpatients Departments at two sites: Barnsley Hospital NHS Foundation Trust and Rotherham Hospital NHS Foundation Trust.

Ethics approval

South Yorkshire REC, 03/03/2010, ref: 10/H1310/8

Study design

Multicentre randomised controlled interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To evaluate the effectiveness of ENAT-focused patient education on the health outcomes of RA patients, measured at baseline, 16 weeks and 32 weeks.

Secondary outcome measures

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.

Overall trial start date

01/06/2010

Overall trial end date

01/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 130; UK sample size: 130

Participant exclusion criteria

Patients with a history of severe mental health problems which would impair their ability to provide informed consent should be excluded

Recruitment start date

01/06/2010

Recruitment end date

01/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barnsley Hospital NHS Foundation Trust
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Barnsley Hospital NHS Foundation Trust (UK)

Sponsor details

Research & Development Department
Pogmoor Road
Barnsley
S75 2EP
United Kingdom

Sponsor type

Government

Website

http://www.barnsleyhospital.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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/26162769
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25422168

Publication citations

Additional files

Editorial Notes