Contact information
Type
Scientific
Primary contact
Prof G.H.M.B. van Rens
ORCID ID
Contact details
Vrije University Medical Centre
Department of Ophthalmology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 4795
rens@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR1031; 94305005
Study information
Scientific title
Acronym
Study hypothesis
The most important objectives in this study are:
1. The actual process of counselling, prescribing and delivering a Closed Circuit Television (CCTV) to visually impaired adults
2. The development of a standardised method to instruct and train patients how to use a CCTV
3. The effectiveness of this instruction and training program in the use of a CCTV, and
4. The feasibility of this instruction and training program
It is to be expected that a standardised instruction program on how to use a CCTV will improve acceptance and that the frequency and time and number of tasks this aid is used by visually impaired people as well as reading speed, compared to those who only get the usual delivery instruction will be higher.
Ethics approval
Approved by the Medical Ethics Committee of the VU University Medical Center, Amsterdam
Study design
Multicentre single blinded randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Eye conditions, Visual impairment
Intervention
The intervention will consist of the newly developed standardised training program in the use of the CCTV for those persons who were counselled for this use in the three national Dutch rehabilitation centres.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The development of an optimal rehabilitation protocol for the instructions of the use of CCTVs for visually impaired adults. It will focus on several specific objectives:
1. To study the present process of counselling, prescribing and delivering a CCTV to visually impaired patients
2. To develop a standardized method to instruct and train visually impaired patients in using a CCTV
3. To study the effectiveness of this instruction and training program in the use of a CCTV
4. To study the feasibility of this instruction and training program
Secondary outcome measures
1. Reading speed (LEO test)
2. Understanding of texts (Aarnoutse test)
3. Activity inventory, frequency, nature and time of the use of a CCTV
Overall trial start date
01/12/2007
Overall trial end date
01/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Visually impaired according to the Dutch guidelines
2. Acceptance of the conditions of the study (informed consent)
3. Above age of 18 years
4. Sufficient understanding of the Dutch language (Cito-NT2 level higher than or equal to 3)
5. Competence to understand the questions of the questionnaires (adequate cognitive ability)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
Patient stays (or stayed before) in a psychogeriatric institution.
Recruitment start date
01/12/2007
Recruitment end date
01/10/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
Department of Ophthalmology
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20219120
Publication citations
-
Protocol
Burggraaff MC, van Nispen RM, Melis-Dankers BJ, van Rens GH, Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial., BMC Health Serv Res, 2010, 10, 62, doi: 10.1186/1472-6963-10-62.