Condition category
Eye Diseases
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Helen Fairlamb

ORCID ID

Contact details

Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
-
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 we aim 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, 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 below 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 21mmHg), 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 intra ocular pressures/
2.3. Chronic Open Angle Glaucoma (COAG): Any combination of raised intra ocular 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

Sponsor information

Organisation

North Cumbria University Hospitals NHS Trust (UK)

Sponsor details

West Cumberland Hospital
Hensingham Whitehaven
Cumbria
CA28 8JG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.