Condition category
Eye Diseases
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
26/09/2014
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

Ms Heidi Cate

ORCID ID

Contact details

Norfolk and Norwich University Hospital NHS Trust
Glaucoma Research Unit
Norwich
NR4 7UY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6798

Study information

Scientific title

A single centre randomised interventional trial of additional education and advice about glaucoma verus standard care in improving adherence with topical anti-glaucomatous therapy

Acronym

Adherence study

Study hypothesis

To determine whether additional education and advice about glaucoma and its management, over and above standard care, is beneficial and cost-effective in improving adherence with topical anti-glaucomatous therapy.

As of 22/12/2010 this record was extensively updated; all changes can be found in the relevant field with the above update date. At this time, the anticipated end date was extended from 22/11/2010 to 22/11/2011.

Ethics approval

MREC approved on the 19th February 2008 (ref: 08/H0310/11)

Study design

Single centre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

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, Primary Care Research Network for England; Subtopic: Not Assigned, Eye (all Subtopics); Disease: Ophthalmology, All Diseases

Intervention

The Education and Support intervention will be delivered by four GSAs using motivational interviewing techniques.

Added 22/12/2010:
Duration of follow-up is 8 months. Intervention not disclosed due to masking of physicians working within the department.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Percentage adherence rate compared between control and intervention group.

Added 22/12/2010:
Outcome measures are recorded at 2 months and 8 months post-randomisation.

Secondary outcome measures

1. Correlate the level of self-reported adherence with actual adherence and determine associative factors
2. Identify the demand for specific components of the glaucoma support intervention
3. Identify predictors of the level of adherence

Added 22/12/2010:
Outcome measures are recorded at 2 months and 8 months post-randomisation.

Overall trial start date

23/11/2009

Overall trial end date

22/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Added 22/12/2010:
1. Newly diagnosed or previously untreated glaucoma patients and ocular hypertension patients prescribed Travoprost
2. Over 18 years old, no upper age limit
3. Male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 200

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

23/11/2009

Recruitment end date

22/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Sponsor type

Government

Website

http://www.nnuh.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23171166
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24655814

Publication citations

  1. Protocol

    Cate H, Bhattacharya D, Clark A, Fordham R, Notley C, Broadway DC, Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management., BMC Ophthalmol, 2012, 12, 57, doi: 10.1186/1471-2415-12-57.

  2. Results

    Cate H, Bhattacharya D, Clark A, Fordham R, Holland R, Broadway DC, Improving adherence to glaucoma medication: a randomised controlled trial of a patient-centred intervention (The Norwich Adherence Glaucoma Study)., BMC Ophthalmol, 2014, 14, 32, doi: 10.1186/1471-2415-14-32.

Additional files

Editorial Notes