Counselling, prescribing and instruction-effects of closed circuit television systems in rehabilitation of visually impaired adults

ISRCTN	ISRCTN80599264
DOI	https://doi.org/10.1186/ISRCTN80599264
Secondary identifying numbers	NTR1031; 94305005

Submission date: 05/09/2007
Registration date: 05/09/2007
Last edited: 16/08/2010

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof G.H.M.B. van Rens
Scientific

Vrije University Medical Centre
Department of Ophthalmology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 4795
Email	rens@vumc.nl

Study information

Study design	Multicentre single blinded randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study objectives	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(s)	Approved by the Medical Ethics Committee of the VU University Medical Center, Amsterdam
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2007
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120
Key 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)
Key exclusion criteria	Patient stays (or stayed before) in a psychogeriatric institution.
Date of first enrolment	01/12/2007
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre

Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Department of Ophthalmology
Amsterdam
1081 BT
Netherlands

Website	http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

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	10/03/2010		Yes	No