The most important objectives in this study are: (1) the development of a standardized method to instruct and train patients how to use a CCTV; (2) the effectiveness of this instruction and training program in the use of a CCTV and (3) theā¦
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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:
- To study the present process of counselling, prescribing and delivering a
CCTV to visually impaired patients.
- To develop a standardized method to instruct and train visually impaired
patients in using a CCTV.
- To study the effectiveness of this instruction and training program in the
use of a CCTV.
- To study the feasibility of this instruction and training program.
Secondary outcome
- Reading speed (LEO test)
- Understanding of texts (Aarnoutse test)
- Activity Inventory
- Frequency, nature and time of the use of a CCTV
Special attention will be given to several other aspects which can interfere
with the study:
- Visual acuity
- Competence to use the CCTV (such as stroke and arthritis)
- Living alone or with a partner (care giver)
- Previous reading habits
- Previous use of other low vision aids and electronic devices (acceptance)
- Prevalence of co-morbidity (since this can have a negative effect on the
outcome)
Background 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.
Study objective
The most important objectives in this study are: (1) the development of a
standardized method to instruct and train patients how to use a CCTV; (2) the
effectiveness of this instruction and training program in the use of a CCTV and
(3) the feasibility of this instruction and training program.
Study design
The design of the study is a two group pragmatic randomised controlled trial.
One group will receive the CCTV as soon as possible after the prescription and
will receive only the usual delivery instructions by the distributor of the
aid; this group will serve as control group. The other group will follow our
newly developed and standardised training program on how to use the CCTV.
Before entering the randomisation process, the first measurements will be
performed (baseline); immediately after receiving the CCTV (before entering the
training program) and three months later when the program is finished data will
be collected during a home visit. To make objective measurements possible,
videotapes will be used. We will videotape the use of the CCTV in the
participants own house. These tapes will be rated by independent investigators,
who are not aware which patients received training, using a rating protocol. We
will investigate several outcomes. First, we will use reading speed of both a
standardised text and the participant*s own texts but we will also focus on the
participants usual reading activities and needs. To assess if the participant
understands the texts, Aarnoutse tests combined with quiz questions will be
used. Second, we will use several measures such as visual acuity, age, gender,
years of education, former reading activities and co-morbidity as co-variables.
Third, we will
ask participants to register the use of the CCTV and ask them in a
semi-structured way to the use as well. Finally, to study the feasibility, we
will discus the effects of the process of counselling, prescribing the CCTV and
delivery instructions and training with both patients and rehabilitation
workers. After finishing the study we will inform rehabilitation workers in the
field of low vision on the outcomes of our study.
Intervention
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.
Study burden and risks
To minimize the respondent burden, the baseline questionnaires will be taken
during the client intake at the MRCs. Participants will receive the delivery
instructions or the training program on the use of CCTVs in their own
environment so there will not be the extra effort of an other visit to the
MRCs. In the data collection phase of the study, participants will be
videotaped during two home visits, to register the use of the CCTV. The
videotapes will only be viewed by the investigators and will be kept safe. This
will take roughly one hour, in which they will perform all the tests and
questionnaires needed. We realize this is an extra effort for the participants.
Though, we feel that the relevance of the study indicates this can be asked of
them. The voluntary nature of participation will be emphasized on every
occasion. Moreover, in former research by de Boer et al. (2005) with visually
impaired elderly, we have experienced that many participants were enthusiastic
about participating in scientific research. A possibility in this study is the
harm we do to the control group by abstaining them from the training program,
therefore the training program will be offered to this group after the study as
well.
Boelelaan 1117
1007 MB Amsterdam
Nederland
Boelelaan 1117
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Visually impaired according to the Dutch guidelines
Acceptance of the conditions of the study (informed consent)
Above age of 18 years
Sufficient understanding of the Dutch language
Competence to understand the questions of the questionnaires
Exclusion criteria
Patient stays (or stayed before) in a psychogeriatric institution.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ISRCTN | ISRCTN80599264 |
CCMO | NL19092.029.07 |