Randomised Controlled Trial of Low Vision Rehabilitation Services.
| ISRCTN | ISRCTN08985063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08985063 |
| Secondary identifying numbers | RHC18039 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/12/2009
- 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
Dr Robert Harper
Scientific
Scientific
Central Manchester Healthcare NHS Trust
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom
| Phone | +44 (0)161 276 5508 |
|---|---|
| robert.harper@man.ac.uk |
Study information
| Study design | Three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The proposed study is a 3-arm randomised controlled trial, comparing the effectiveness of a conventional hospital based optometric low vision service and an integrated low vision service for patients with age related macular degeneration (ARMD). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye diseases: age-related macular degeneration |
| Intervention | Plan of Investigation ARM 1 : Patients will receive conventional optometric low vision care in Hospital Eye Service. ARM 2 : Patients will receive integrated low vision care. In addition to conventional optometric management, these patients will be seen three times by a trained low vision rehabilitation officer. The officer will give specific rehabilitation training. ARM 3 : Patients in arm 3 will receive conventional optometric management and will be seen three times by a community care worker - specific rehabilitation training will not be given by the community care worker (age concern). |
| Intervention type | Other |
| Primary outcome measure | Primary outcome measures include: Low vision specific and generic health status questionnaires, and measures of vional function. In addition, the study aims to estimate and compare the costs of these models of low vision care. Main study outcomes include : Visual Functions - near and distance logMAR visual acuity, contrast sensitivity, reading speed. Low vision symptoms - MREH low vision questionnaire. Quality of Life - SF36 questionnaire, Nottingham Adjustment Scale. Health and Welfare Service usage - including hospital visits, contacts with GP's, other members of the Primary Care Team, Social Services and voluntary organisations. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1997 |
| Completion date | 01/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 225 |
| Key inclusion criteria | We propose to recruit 225 new patients (75 in each group) on the basis of a recent audit of the low vision service at MREH. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1997 |
| Date of final enrolment | 01/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Central Manchester Healthcare NHS Trust
Manchester
M13 9WH
United Kingdom
M13 9WH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2001 | Yes | No | |
| Results article | results | 01/11/2004 | Yes | No |
