Health of Patients' Eyes in Glaucoma Clinics: HOPE Glaucoma
| ISRCTN | ISRCTN41306818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41306818 |
| Protocol serial number | 14767 |
| Sponsor | North Cumbria University Hospitals NHS Trust (UK) |
| Funder | International Glaucoma Association (UK) |
- 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
Scientific
Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
| helen.fairlamb@ncuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Not specified |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 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(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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Cumberland Infirmary
Carlisle
CA2 7HY
United Kingdom
CA2 7HY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/08/2017 | Yes | No | |
| Protocol article | protocol | 07/08/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/02/2017: Publication reference added.
05/05/2016: Publication reference added.
