|- candidate number||2684|
|- NTR Number||NTR1031|
|- Date ISRCTN created||5-sep-2007|
|- date ISRCTN requested||31-aug-2007|
|- Date Registered NTR||30-jul-2007|
|- Secondary IDs||94305005 |
|- Public Title||Counselling, prescribing and instruction-effects of closed circuit television systems in rehabilitation of visually impaired adults. |
|- Scientific Title||Counselling, prescribing and instruction-effects of closed circuit television systems in rehabilitation of visually impaired adults. |
|- ACRONYM||Closed circuit television systems instruction-effects |
|- hypothesis||The most important objectives in this study are:
1. The actual process of counselling,
prescribing and delivering a CCTV to visually impaired adults;
2. Tthe development of a standardized 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 standardized 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.|
|- Healt Condition(s) or Problem(s) studied||Visual impairment, Eye conditions|
|- Inclusion criteria||1. Visually impaired according to the Dutch guidelines (De Boer et al., 2004)
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)
|- Exclusion criteria||Patient stays (or stayed before) in a psychogeriatric institution. |
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-dec-2007|
|- planned closingdate||1-okt-2009|
|- Target number of participants||120|
|- Interventions||The intervention will consist of the newly developed standardized training program in the use of the CCTV for those persons who were counselled for this use in the three national Dutch rehabilitation centres|
|- Primary outcome||1. 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:
a. To study the present process of counselling, prescribing and delivering a CCTV to visually impaired patients.
b. To develop a standardized method to instruct and train visually impaired patients in using a CCTV.
c. To study the effectiveness of this instruction and training program in the use of a CCTV.
d. To study the feasibility of this instruction and training program
|- Secondary outcome||1. Reading speed (LEO test)
2. Understanding of texts (Aarnoutse test)
3. Activity Inventory, Frequency, nature and time of the use of a CCTV
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. G.H.M.B. Rens, van |
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD student MC Burggraaff|
|- Sponsor/Initiator ||VU University Medical Center, Department of Ophthalmology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Burggraaff MC, Nispen RMA van, Boer MR de, Rens GHMB van (2006): Optometric and
multidisciplinary approaches in prescribing low vision aids-Revised. Visual impairment research. 2006; 8: 7-24.
Burggraaff MC, Nispen RMA van, Boer MR de, Rens GHMB van (2005): Optometric and
multidisciplinary approaches in prescribing low vision aids. Visual impairment research. 2005; 7: 71-78.
|- Brief summary||One of the major problems of visually impaired people is the inability to read. These reading problems are a major threat to the social functioning and independency. Important goals of rehabilitation processes are counselling, to prescribe reading aids and to give instructions how to use these aids. A closed-circuit television system (CCTV) offers the highest level of magnification of all low vision aids and is therefore prescribed to those patients who have profound or severe low vision. For many patients it takes effort to actually use the device and sometimes the prescribed CCTV will not be used at all. Studies on the process of counselling, prescribing CCTVs and on the effects of instructions on the use are scarce and standardized protocols are lacking. Also, those studies regarding the use of CCTVs performed in the past mainly focus on reading speed and are hard to compare. Other aspects of outcome such as the benefits and problems of CCTVs are virtually unknown. This study will examine the whole process of counselling and prescribing CCTVs and the outcomes of the use of CCTVs. |
|- Main changes (audit trail)|
|- RECORD||30-jul-2007 - 24-sep-2007|