Helping adherence with glaucoma treatment: a randomised trial

ISRCTN	ISRCTN89683704
DOI	https://doi.org/10.1186/ISRCTN89683704
Protocol serial number	6798
Sponsor	Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 26/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Heidi Cate
Scientific

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

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Adherence study
Study objectives	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(s)	MREC approved on the 19th February 2008 (ref: 08/H0310/11)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	22/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	23/11/2009
Date of final enrolment	22/11/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Norfolk and Norwich University Hospital NHS Trust

Norwich
NR4 7UY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/03/2014		Yes	No
Protocol article	protocol	22/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes