Condition category
Eye Diseases
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
16/08/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/english/

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

  1. 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.

Additional files

Editorial Notes