The objective of this study is to develop and test a DSL-protocol which will focus on proper use of hearing-aids, and will also provide patients (and their significant others) with specific skills to improve the use of the senses and communication.…
ID
Source
Brief title
Condition
- Hearing disorders
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes will be measurde by the effects of the intervention on:
hearing-aid use, hearing-aid satisfaction, skills, compliance and
communication. The change in these primary outcomes will be measured using
several questions and tasks; examples are:
1. Specific tasks that will show the ability of the person and/or proxy to use
and manage the hearing-aid will be tested. The
patient and/or proxy will be asked to show how to put the hearing-aid in the
ear and getting it out properly, how to make sure
that the working mechanisms function properly, how to control the volume, and
how to clean, manage and change batteries.
Each task that is completed successfully will be rated by the research
assistant.
2. Communication improvement will be measured with the Communication Strategies
scale [11]. This scale consists of
statements on the patients* attitudes towards communication (e.g. watching a
person*s face facilitates communication, I am
aware of the benefits of speech reading and significant others take my hearing
loss into account). The attitudes are rated on a
five-point scale. Some statements will be changed to *dual sensory loss*
instead of *hearing loss*.
3. Communication Strategies domain of the Dutch Communication Profile for the
Hearing Impaired (CPHI) [17] will be used to
assess change in outcomes. The Communication Strategies of the CPHI consist of
three scales: Maladaptive Behavior (9
items, e.g. dominate conversation, avoid social situations, avoid
conversations, pretend to understand); Verbal Strategies (8
items, e.g. ask for repeat twice, explain hearing loss, ask people to speak up)
and Nonverbal Strategies (8 items, e.g. position
myself to hear, stay in well-lit areas at parties, watch person*s face).
Secondary outcome
The secundary outcomes will be measured by the effects of the intervention on
coping, social participation and perceived quality of life.
Change in the secondary outcomes (coping, social participation and quality of
life) will be measured with four questionnaires:
1. The Personal Adjustment domain of the CPHI (Mokkink et al, 2009) will be
used to assess change in adjustment to hearing loss. The Personal Adjustment
domain of the CPHI consist of four scales: Self-Acceptance (8 items, e.g. get
upset when can*t follow conversation, feel foolish when misunderstand),
Acceptance of Loss (9 items, e.g. try to hide hearing problem, rather miss
conversation than admit hearing loss), Stress and Withdrawal (15 items, e.g.
feel threatened by communication situations, feeling tense and anxious when
can*t understand, feel left out of conversations, don*t enjoy going places with
friends).
2. The Dutch Activity Inventory which is based on Massof*s Activity Inventory
and was recently translated and validated (Massof et al, 2005 and Bruijning et
al 2009). The D-AI can be used to assess rehabilitation needs and outcomes in
the ICF-domains. In this study, two ICF domains of the D-AI will be assessed,
namely Interpersonal Interactions and Relationships (6 rehabilitation goal
items, e.g. recognition and communication, interaction with partner, family,
relatives and friends); Community, Social and Civil Life (14 rehabilitation
goal items, e.g. follow the news, having visitors, social events, attend
cultural events, dining out, creative activities). For every goal will be asked
how important and how difficult the goal is on a 4 point-scale (not important -
very important) and a 5-point scale respectively (not difficult - impossible to
do without assistance). Multiplying both scores will provide a priority list of
rehabilitation goals. After the intervention it is expected that priorities
have diminished, either because the rehabilitation goal became less important,
or the goal became less difficult because of the intervention.
3. The Low Vision Quality Of Life questionnaire (LVQOL) will be used to assess
the vision-related quality of life outcomes of patients (Wolffsohn and Cochrane
(2000) and Van Nispen et al, 2009). The LVQOL consists of four scales: Basic
Aspects of vision (5 items, e.g. problems watching television, glare),
vision-related Mobility (5 items, e.g. crossing a street with traffic, getting
around outdoors), Adjustment to vision loss (4 items, e.g. frustrated about not
being able to do tasks because of vision, not able to visit friends or family),
reading and fine work (7 items, e.g. reading labels on medicine bottles,
reading newspaper, finding out the time, writing).
4. The Reaction of Others scale of the Hearing Handicap and Disability
Inventory (HHDI) (van den Brink, 1995) will be used to measure attitudes of
significant others towards the impairment of their partner or family member
(Kramer et al, 2004). Examples of items are I leave the impaired person out of
conversation when he/she cannot understand what is being said, I avoid starting
conversations with my impaired partner, I have the patience to repeat every
word if necessary.
References:
Brink RHS van den. Attitude and illness behavior in hearing impaired elderly.
Thesis. Rijks University of Groningen. 1995,
the Netherlands, ISBN 90-9008014-7.
Bruijning JE, van Nispen RMA, Van Rens GHMB. Feasibility of the Dutch Activity
Inventory (D-AI): A pilot study., accepted pending revisions in Ophthalmic
Epidemiology, Dec 2009.
Kramer SE, Allessie GH, Dondorp AW, Zekveld AA, Kapteyn, TS. A home education
program for older adults with hearing
impairment and their significant others: a randomized trial evaluating short-
and long-term effects. Int J Audiol, 2005;44:255-64.
Massof RW, Hsu CT, Baker FH, Barnett GD, Park WL, Deremeik JT et al. Visual
disability variables. I: the importance and difficulty of activity goals for a
sample of low-vision patients. Arch Phys Med Rehabil 2005;86:946-53.
Mokkink LB, Knol DL, Zekveld AA, Goverts ST, Kramer SE. Factor structure and
reliability of the Dutch version of seven scales of the Communication Profile
for the Hearing Impaired (CPHI). J Speech Lang Hear Res, 2009;52:454-64.
Nispen RMA van, Knol DL, Neve JJ, van Rens GHMB. A multilevel item response
theory model was developed for
longitudinal vision-related quality-of-life data. J Clin Epidemiol, 2009, Sep
17. [Epub ahead of print].
Wolffsohn JS, Cochrane AL. Design of the Low Vision Quality Of Life
questionnaire (LVQOL) and measuring the outcome
of low-vision rehabilitation. Am J Ophthalmology, 2000;130:793-802.
Background summary
Recent studies have shown that relatively many older adults suffer from a dual
sensory impairment (5-9%), caused by
degenerative processes in the eye (e.g. macular degeneration) and inner-ear
(e.g. presbycusis). In a number of studies it has
been reported that a dual sensory impairment relates to great problems in
communication, health and social participation, but
also in the use of hearing aids. In the low vision rehabilitation centers, no
structural care is provided to detect hearing loss in
visually impaired patients. Occasionally the dual sensory impairment will be
addressed, but usually only when hearing loss is
obvious. Providing a structural and integrated approach to care for dual
sensory impairments is necessary from the perspective
that maximizing the use of remaining vision will become more effective if the
other senses are used to the maximum as well.
The development and evaluation of multidisciplinary interventions addressing
the bi-modal difficulties of older people has
recently been considered as one of the most urgent research needs.
Study objective
The objective of this study is to develop and test a DSL-protocol which will
focus on proper use of hearing-aids, and will also provide patients (and their
significant others) with specific skills to improve the use of the senses and
communication. Specific research questions are (a) What is the effect of using
a DSL-protocol in older adults with dual sensory impairment on the use of
hearing-aids, such as basic managing skills and compliance; and (b) on
communication, coping, social participation and quality of life?
Study design
In a multi-center international single blind randomized controlled trial, we
propose to develop and test a *Dual Sensory
Loss-protocol* (DSL-protocol) for older adults with dual sensory impairment who
are clients of multidisciplinary low vision rehabilitation
centers in the Netherlands and Belgium.
Intervention
Trained occupational therapists will administer the DSL-protocol to patients
and proxies in the intervention group. The intervention consists of a
training and exercises on (1) using and managing the hearing-aid; (2) making
maximum use of the senses; and (3) communication skills. Up to five
appointments will be made in the intervention group by the occupational
therapist at the multidisciplinary rehabilitation center or in the patients
home, depending on the performance by the patient and/or proxy.
Study burden and risks
The extent of burden associated with participation consists of two measurements
and an occupational therapy treatment. The measurements include an interview
(duration approximately 1,5 hours). In this interview, several questionnaires
will be assessed. The patient will also conduct a hearing test (speech-in-noise
test). In case the patient is randomized into the intervention group, he will
get the treatment which will consist of 3 to 5 session at the rehabilitation
center or at the patients home.
De Boelelaan 1117
1007 MB Amsterdam
NL
De Boelelaan 1117
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- At least 50 years of age
- Combined vision and hearing impairment
- Clients of low vision rehabilitation centers in the Netherlands (Bartiméus) or Belgium (Blindenzorg Licht en Liefde)
Exclusion criteria
- Cognitively impaired
- Not able to speak and/or understand Dutch
Design
Recruitment
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 |
---|---|
CCMO | NL36469.029.11 |
Other | TC = 2843 |