Providing glaucoma information as per clinical standard

ISRCTN ISRCTN91188805
DOI https://doi.org/10.1186/ISRCTN91188805
Secondary identifying numbers N/A
Submission date
22/09/2017
Registration date
21/11/2017
Last edited
11/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Glaucoma is an eye condition where the nerve that connects the eye to the brain is damaged, leading to vision loss. Once sight is lost through glaucoma it cannot be got back so stopping sight loss in patients with glaucoma is important. One way in which doctors, opticians and nurses can help patients is to teach them about their glaucoma so that patients know how and have the skills to look after their eyes in the best way possible. This study aims to find out how much information on glaucoma is given to patients in glaucoma clinics held by nurses and how nurses could best give information about taking care of their eyes.

Who can participate?
Adults aged 18 and older who have glaucoma

What does the study involve?
Participants attend two session education programmes on week apart. The educational sessions include how to best take care of their glaucoma. Participants are assessed for their knowledge of glaucoma and their adherence to treatment before and after the educational programmes.

What are the possible benefits and risks of participating?
Participants will benefit from having learnt more about glaucoma and what they can do to help themselves. Nurses will benefit as they will expand their range of patient teaching options. There are no risks of this study apart from the burden of time for the nurses in learning and giving the patient classes and to the patients in terms of finding the time to attend.

Where is the study run from?
1. Royal Liverpool University Hospital (UK)
2. New Cross Hospital (UK)
3. Abergele Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2011 to December 2014

Who is funding the study?
International Glaucoma Association (UK)

Who is the main contact?
Professor Heather Waterman
watermanh1@cardiff.ac.uk

Contact information

Prof Heather Waterman
Scientific

School of Healthcare Sciences
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom

ORCiD logoORCID ID 0000-0001-7052-2734
Phone +44 (0)2920 918872
Email watermanh1@cardiff.ac.uk

Study information

Study designQuantitative and qualitative sequential design study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleGroup based patient education delivered by nurses to meet a clinical standard for glaucoma information provision: the G-TRAIN feasibility study
Study acronymGTrain study
Study objectivesThe aim of this study is to understand current provision of information during routine nurse-led glaucoma consultations, to investigate if it is possible to deliver patient information in-line with a clinical standard by training nurses to deliver group based education in multiple hospital sites, and to explore the acceptability of group based education to nurses and patients compared with usual information provision in consultations.
Ethics approval(s)North West Research Ethics Committee, 08/06/2012, ref: 12/NW/0259
Health condition(s) or problem(s) studiedGlaucoma
InterventionPeople diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England are recruited. Participants receive a group based patient education called "GTrain" which has been developed to train healthcare professionals so that they can deliver group based education to patients about glaucoma which will help them to manage their condition appropriately. The programme is a two-session education programme is delivered one week apart. A combined adult learning and health needs approach to education is taken.

Registered nurses who had received training in the delivery of the intervention deliver the programme. The training consisted of a two day interactive workshop in which the structure and content of the ‘Get a grip on your glaucoma’ course was covered. Participants receive the programme face to face in a group. Participants have the opportunity to get individualised advice offered at the end of the group intervention. The intervention was delivered in a room on the hospital site of where the nurses worked.

Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health. Adherence was also measured objectively using a Medical Events Monitoring System device.
Intervention typeBehavioural
Primary outcome measureThe information provided to patients during routine nursing glaucoma appointments is measured using the Provision of Vision Information Measurement Too at baseline and after programme.
Secondary outcome measuresThere are no secondary outcome measures.
Overall study start date01/02/2011
Completion date16/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. Patients with chronic open angle glaucoma (COAG)
2. Ocular hypertension (OHT) or normal tension glaucoma
3. Prescribed ocular hypotensive eye drops
4. Aged over 18 years
5. Able to understand English to be able to give consent or have an interpreter
Key exclusion criteria1. Diagnosis of angle closure glaucoma or diabetic retinopathy
2. Not prescribed ocular medication
Date of first enrolment31/12/2012
Date of final enrolment17/10/2014

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Wales

Study participating centres

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom
Abergele Hospital
Llanfair Road
Abergele
LL22 8DP
United Kingdom

Sponsor information

University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone +44 (0)161 306 6000
Email clifford.richardson@manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Charity

International Glaucoma Association
Private sector organisation / Associations and societies (private and public)
Alternative name(s)
IGA
Location
United Kingdom

Results and Publications

Intention to publish date01/01/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal. The article is under review at time of submission to the registry.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/07/2018 Yes No

Editorial Notes

11/07/2018: PubMed address added.
09/07/2018: Publication reference added.