Adherence to therapy for patients with glaucoma or ocular hypertension
ISRCTN | ISRCTN13706134 |
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DOI | https://doi.org/10.1186/ISRCTN13706134 |
Secondary identifying numbers | N0453168857 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 11/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David B Henson
Scientific
Scientific
REH Central Manchester & Manchester Children's University Hospitals
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom
Phone | +44 0161 276 5507 |
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david.henson@manchester.ac.uk |
Study information
Study design | Two-arm pilot randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
Scientific title | Adherence to therapy for patients with glaucoma or ocular hypertension |
Study objectives | Current hypothesis as of 03/04/2008: An individualised programme of care can improve adherence to therapy in newly treated cases of glaucoma or ocular hypertension Previous hypothesis: To establish the effect of enhanced nursing input to the persistency of therapy in newly treated cases of glaucoma and ocular hypertension. Please note that the trial title was "The impact of enhanced nursing input on persistency of therapy in newly treated cases of glaucoma and ocular hypertension" until April 2008. |
Ethics approval(s) | Central Manchester Local Research Ethics Committee, 20/12/2004, amendment approved on 15/06/2005 |
Health condition(s) or problem(s) studied | Eye Diseases: Glaucoma |
Intervention | Added April 2008: This pilot study has three parts. Part 1: A Cochrane Systematic Review entitled, Interventions for improving adherence to ocular hypotensive therapy. Protocol for the Cochrane review published on: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006132/pdf_fs.html Part 2: A cross-sectional study to collect baseline data entitled, Factors associated with poor adherence to ocular hypotensive therapy. Data will be collected via observation and interview from the outpatient clinic of the host organisation for patients diagnosed with glaucoma or ocular hypertension. This will include: 2.1 Observation of clinical practice in relation to verbal and written information regarding the use of eye drops and follow-up care, adherence to therapy advice and eye drop training. 2.2 Face to face interviews with patients to establish their knowledge of glaucoma, daily eye care management and problems associated with managing eye drops. Adherence to therapy will also be measured. Part 3: A two-arm randomised controlled trial entitled the impact of an individualised programme of care on persistence of and adherence to therapy in newly treated cases of glaucoma or ocular hypertension. Stratification will take place on the basis of the type of clinic patients attend. In arm 1 (non-intervention arm) patients will continue to receive the information, advice and training they would normally be given at the host organisation. In arm 2 (intervention arm), patients will, in addition, undergo an assessment by a research nurse that takes into account factors such as other medical conditions, additional medications, independence with daily living activities, potential problems managing an eye drop regime and beliefs about medications etc. Patients will receive a detailed explanation of the importance of therapy adherence, training on eye-drop instillation techniques and handouts giving further information about glaucoma or ocular hypertension. An individualised programme of care will be developed for each patient; this will include a series of follow-up contacts to ensure that the patient is managing their eye-drops and that any issues regarding adherence are dealt with promptly. All included patients will continue to follow the normal treatment protocols of the host organisation. |
Intervention type | Other |
Primary outcome measure | Persistency of treatment during the first year of therapy will be the main outcome measure. Persistency will be measured by comparing the number of doses dispensed and the number prescribed, taking into account that UK prescriptions are valid for 28 days. |
Secondary outcome measures | Added April 2008: Adherence to therapy, illness perceptions, beliefs about medicines and patient enablement. Secondary outcomes will be measured via validated questionnaires during patient interviews at the end of the study. |
Overall study start date | 21/04/2005 |
Completion date | 31/07/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 120 - 60 patients in each arm. |
Key inclusion criteria | Added April 2008: Patients newly prescribed ocular hypotensive eye drops with a diagnosis of open angle glaucoma, normal tension glaucoma, pseudo-exfoliation glaucoma, pigment dispersion glaucoma or ocular hypertension. |
Key exclusion criteria | Added April 2008: Patients unable to give informed consent or patients already prescribed a complicated drop regime for another eye condition. |
Date of first enrolment | 21/04/2005 |
Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
REH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WH
United Kingdom
M13 9WH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
11/04/2017: No publications found in PubMed, verifying study status with principal investigator