Adherence to therapy for patients with glaucoma or ocular hypertension

ISRCTN	ISRCTN13706134
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

REH Central Manchester & Manchester Children's University Hospitals
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom

Phone	+44 0161 276 5507
Email	david.henson@manchester.ac.uk

Study information

Study design	Two-arm pilot randomised controlled trial
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
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

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	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
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