Health of Patients' Eyes in Glaucoma Clinics: HOPE Glaucoma

ISRCTN	ISRCTN41306818
DOI	https://doi.org/10.1186/ISRCTN41306818
Secondary identifying numbers	14767

Submission date: 22/08/2013
Registration date: 22/08/2013
Last edited: 07/02/2017

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

Not provided at time of registration

Contact information

Ms Helen Fairlamb
Scientific

Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom

Email	helen.fairlamb@ncuh.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Health of Patients' Eyes in Glaucoma Clinics: HOPE Glaucoma
Study acronym	HOPE Glaucoma
Study objectives	Glaucoma involves progressive optic nerve fibre loss, subsequently leading to irreversible and disabling visual field defects. In the UK alone, more than 200,000 patients have this condition. Glaucoma patients need to be followed-up periodically, which means it is a large financial and resource burden to the NHS. Glaucoma has a history of poor therapy adherence and lack of patient knowledge of their condition if frequently cited as a cause (Grey et al. 2010). In this study the aim is to assess whether providing patients with a client-held eye health summary (a personal record of their condition) improves patients' knowledge about their disorder and subsequently has a beneficial impact on the rate of deterioration of their eye(s). The hypothesis is that improved disease knowledge, through the introduction of a fairly simple and cheap patient-held tool, improves awareness and contributes to positive behavioral change in patients.
Ethics approval(s)	First MREC approval date 28/09/2012, ref: 12/YH/0471
Health condition(s) or problem(s) studied	Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Glaucoma
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	10/06/2013
Completion date	10/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 122; UK Sample Size: 122
Key inclusion criteria	1. Adult (age > 18 years) 2. Patients diagnosed with glaucoma, to include the following three diseases: 2.1. Ocular Hypertension (OHT): Intra ocular pressures raised above the normal range (more than or equal to 21 mmHg), but no signs of optic nerve fibre loss or visual field loss 2.2. Suspected glaucoma (SG): Optic nerve fibre loss or visual field loss of both in presence of normal intraocular pressures 2.3. Chronic Open Angle Glaucoma (COAG): Any combination of raised intraocular pressures, optic nerve fibre loss and/or visual field loss Target Gender: Male & Female; Upper Age Limit 100 years ; Lower Age Limit 18 years
Key exclusion criteria	1. Under age (< 18 years) 2. Mental incapacity through inability to read, co-morbidities (e.g. severe stroke, advanced dementia) or any other contributing factor 3. Inability to provide informed written consent 4. Unable to speak or understand English since interpreter is not available throughout the course of the study
Date of first enrolment	10/06/2013
Date of final enrolment	10/06/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cumberland Infirmary

Carlisle
CA2 7HY
United Kingdom

Sponsor information

North Cumbria University Hospitals NHS Trust (UK)
Hospital/treatment centre

West Cumberland Hospital
Hensingham Whitehaven
Cumbria
CA28 8JG
England
United Kingdom

Funders

Funder type

Charity

International Glaucoma Association (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/08/2015		Yes	No
Results article	results	30/08/2017		Yes	No

Editorial Notes

07/02/2017: Publication reference added.
05/05/2016: Publication reference added.