Condition category
Eye Diseases
Date applied
22/09/2017
Date assigned
21/11/2017
Last edited
21/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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. The aim of the study is to

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heather Waterman

ORCID ID

http://orcid.org/0000-0001-7052-2734

Contact details

School of Healthcare Sciences
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 2920 918872
watermanh1@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GTrain study

Study information

Scientific title

Group based patient education delivered by nurses to meet a clinical standard for glaucoma information provision: The G-TRAIN feasibility study

Acronym

GTrain study

Study hypothesis

The 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

North West Research Ethics committee, 08/06/2012, ref: 12/NW/0259

Study design

Quantitative and qualitative sequential design study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Glaucoma

Intervention

People 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 type

Behavioural

Phase

Drug names

Primary outcome measures

The 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 measures

There are no secondary outcome measures.

Overall trial start date

01/02/2011

Overall trial end date

16/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Diagnosis of angle closure glaucoma or diabetic retinopathy
2. Not prescribed ocular medication

Recruitment start date

31/12/2012

Recruitment end date

17/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Abergele Hospital
Llanfair Road
Abergele
LL22 8DP
United Kingdom

Sponsor information

Organisation

Univeirsty of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 6000
clifford.richardson@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

International Glaucoma Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. The article is under review at time of submission to the registry.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes