Condition category
Eye Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
18/07/2014
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

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

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 randomised controlled trial - pilot study

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

Not Specified

Gender

Not Specified

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes