Clinical trial NCT00946062: Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision
Official title: The Impact of Orientation and Mobility Training on Mobility, Participation and Quality of Life in Older Adults With Visual Impairments: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Aged
Keywords: low vision
ophthalmology
randomised controlled trial
mobility
orientation
cane
aged
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2009-07-24
Enrollment: 190
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

1. to develop a standardised orientation and mobility training (O\&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
2. to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* Aged 55 years or over
* Low vision
* Living independently in the community or in a home for older people
* Able to see large obstacles and to go outside for a short walk or doing groceries
* One of the following:

  1. experiencing difficulties with safely crossing a street
  2. experiencing difficulties with recognising acquaintances outdoors
  3. willing to become recognisable as being partially sighted by using the identification cane
* Written informed consent
* Orientation and Mobility training (O\&M-training) in the use of an identification cane

Exclusion Criteria:

* Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
* Language or hearing problems that impede completing an interview by telephone
* Confinement to bed or possible nursing home admission that impede completion of the O\&M-training
* Permanent use of a walking aid incompatible with the use of an identification cane
* Having recently received an O\&M-training in the use of an identification cane and permanent use of this cane

Primary outcomes:
measure: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))
timeFrame: 5 and 17 weeks
measure: distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))
timeFrame: 5 and 17 weeks
Secondary outcomes:
measure: activities index (Frenchay Activities Index (FAI))
timeFrame: 5 and 17 weeks
measure: social support interactions (Social Support List (SSL 12-I))
timeFrame: 5 and 17 weeks
measure: health-related quality of life (EuroQol 5D (EQ5D))
timeFrame: 5 and 17 weeks
measure: mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))
timeFrame: 5 and 17 weeks
measure: feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))
timeFrame: 5 and 17 weeks
measure: symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))
timeFrame: 5 and 17 weeks
measure: concerns about falling (falls efficacy scale international (FES-I))
timeFrame: 5 and 17 weeks
Other outcomes:
Locations:
city: Grave
country: Netherlands
facility: Sensis
city: Huizen
country: Netherlands
facility: Royal Visio
city: Utrecht
country: Netherlands
facility: Bartimeus
Study officials:
affiliation: Maastricht University, CAPHRI School for Public Health and Primary Care
name: G.I.J.M. Kempen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballemans J, Zijlstra GA, van Rens GH, Schouten JS, Kempen GI. Usefulness and acceptability of a standardised orientation and mobility training for partially-sighted older adults using an identification cane. BMC Health Serv Res. 2012 Jun 8;12:141. doi: 10.1186/1472-6963-12-141.
citation: Zijlstra GA, van Rens GH, Scherder EJ, Brouwer DM, van der Velde J, Verstraten PF, Kempen GI. Effects and feasibility of a standardised orientation and mobility training in using an identification cane for older adults with low vision: design of a randomised controlled trial. BMC Health Serv Res. 2009 Aug 27;9:153. doi: 10.1186/1472-6963-9-153.