Helping adherence with glaucoma treatment: a randomised trial
| ISRCTN | ISRCTN89683704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89683704 |
| Secondary identifying numbers | 6798 |
- 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
Scientific
Norfolk and Norwich University Hospital NHS Trust
Glaucoma Research Unit
Norwich
NR4 7UY
United Kingdom
Study information
| Study design | Single centre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 23/11/2009 |
| Completion date | 22/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 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
- England
- United Kingdom
Study participating centre
Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
| Website | http://www.nnuh.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/11/2012 | Yes | No | |
| Results article | results | 24/03/2014 | Yes | No |
