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Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

Primary Purpose

Low Vision, Aged

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
orientation and mobility training
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Vision focused on measuring low vision, ophthalmology, randomised controlled trial, mobility, orientation, cane, aged

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sensis
  • Royal Visio
  • Bartimeus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

regular O&M-training

standardised O&M-training

Arm Description

orientation and mobility training in use of the identification cane as provided by mobility trainers

standardised orientation and mobility training in use of the identification cane as provided by mobility trainers who received instruction in using the standardised protocol

Outcomes

Primary Outcome Measures

activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))
distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))

Secondary Outcome Measures

activities index (Frenchay Activities Index (FAI))
social support interactions (Social Support List (SSL 12-I))
health-related quality of life (EuroQol 5D (EQ5D))
mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))
feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))
symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))
concerns about falling (falls efficacy scale international (FES-I))

Full Information

First Posted
July 23, 2009
Last Updated
November 14, 2013
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00946062
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is: 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; to evaluate this newly developed standardised O&M-training with respect to effectiveness and feasibility in a randomised controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision, Aged
Keywords
low vision, ophthalmology, randomised controlled trial, mobility, orientation, cane, aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
regular O&M-training
Arm Type
Active Comparator
Arm Description
orientation and mobility training in use of the identification cane as provided by mobility trainers
Arm Title
standardised O&M-training
Arm Type
Experimental
Arm Description
standardised orientation and mobility training in use of the identification cane as provided by mobility trainers who received instruction in using the standardised protocol
Intervention Type
Other
Intervention Name(s)
orientation and mobility training
Intervention Description
orientation and mobility training
Primary Outcome Measure Information:
Title
activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))
Time Frame
5 and 17 weeks
Title
distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))
Time Frame
5 and 17 weeks
Secondary Outcome Measure Information:
Title
activities index (Frenchay Activities Index (FAI))
Time Frame
5 and 17 weeks
Title
social support interactions (Social Support List (SSL 12-I))
Time Frame
5 and 17 weeks
Title
health-related quality of life (EuroQol 5D (EQ5D))
Time Frame
5 and 17 weeks
Title
mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))
Time Frame
5 and 17 weeks
Title
feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))
Time Frame
5 and 17 weeks
Title
symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))
Time Frame
5 and 17 weeks
Title
concerns about falling (falls efficacy scale international (FES-I))
Time Frame
5 and 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: experiencing difficulties with safely crossing a street experiencing difficulties with recognising acquaintances outdoors 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G.I.J.M. Kempen, PhD
Organizational Affiliation
Maastricht University, CAPHRI School for Public Health and Primary Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensis
City
Grave
Country
Netherlands
Facility Name
Royal Visio
City
Huizen
Country
Netherlands
Facility Name
Bartimeus
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22681932
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.
Results Reference
derived
PubMed Identifier
19712448
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.
Results Reference
derived

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Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

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