Contact information
Type
Scientific
Primary contact
Prof David B Henson
ORCID ID
Contact details
REH Central Manchester & Manchester Children's University Hospitals
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom
+44 0161 276 5507
david.henson@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453168857
Study information
Scientific title
Adherence to therapy for patients with glaucoma or ocular hypertension
Acronym
Study hypothesis
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
Central Manchester Local Research Ethics Committee, 20/12/2004, amendment approved on 15/06/2005
Study design
Two-arm pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
21/04/2005
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 - 60 patients in each arm.
Participant exclusion criteria
Added April 2008:
Patients unable to give informed consent or patients already prescribed a complicated drop regime for another eye condition.
Recruitment start date
21/04/2005
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
REH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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