Contact information
Type
Scientific
Primary contact
Ms Helen Fairlamb
ORCID ID
Contact details
Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
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helen.fairlamb@ncuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14767
Study information
Scientific title
Health of Patients' Eyes in Glaucoma Clinics: HOPE Glaucoma
Acronym
HOPE Glaucoma
Study hypothesis
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 patientsÂ’' 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
First MREC approval date 28/09/2012, ref: 12/YH/0471
Study design
Randomised; Interventional; Design type: Not specified
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 to request a patient information sheet
Condition
Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Glaucoma
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/06/2013
Overall trial end date
10/06/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 122; UK Sample Size: 122
Participant 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
Recruitment start date
10/06/2013
Recruitment end date
10/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cumberland Infirmary
Carlisle
CA2 7HY
United Kingdom
Funders
Funder type
Charity
Funder name
International Glaucoma Association (UK)
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 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26248726
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28165608