Zijlstra 2009.

Trial name or title	A parallel group randomised controlled trial developed to evaluate a standardised O&M training in the use of an identification cane (NCT00946062). The trial is conducted in collaboration with the two main organisations for low vision rehabilitation care in The Netherlands: Bartiméus and the VisioSensisDeBrink Group (as of January 2010: Royal Visio).
Methods	Cluster randomised trial. In 18 local centres, which are scattered over The Netherlands, O&M training is provided to older persons with visual impairment. The centres were randomly allocated to the control group or intervention group stratified by organisation (at that time: Bartiméus – four local centres, Sensis – four local centres, and Visio – 10 local centres). Due to the nature of the trial and the information provided to clients before the start of the trial (required by the Medical Ethical Committee), mobility trainers, researchers and participants are not masked to intervention status. Participants are, however, not informed about their intervention status until the start of the O&M training. Trained outcome assessors who perform the interviews by telephone are masked to intervention status. Data for the effect evaluation are collected at baseline, and at five and 17 weeks after the start of the O&M training during 40 minute interviews by telephone. Trained interviewers, who are masked to group allocation, perform the interviews. In addition, a 25 minute interview by telephone is performed at eight weeks after the start of the O&M training to obtain data for the process evaluation from participants in the intervention group as well as the control group. Pre‐structured questionnaires on process aspects are used to gather data from the mobility trainers per participant. Trainers receive this questionnaire before the first session of the participant's O&M training. As recommended by Hollis 1999, non‐compliant participants are approached for all follow‐up assessments.
Participants	Community‐dwelling older people who ask for support at a rehabilitation centre for people with visual impairment and who are likely to receive an O&M training in using the identification cane are included in the trial (N = 190).
Interventions	The standardised O&M training aims to facilitate safe and independent participation in the community by optimal use of one's abilities, and to facilitate uptake of old or new activities. To achieve these aims several strategies were added to the regular O&M training, that is: prioritising the client's needs, cognitive restructuring, action planning, contracting, providing direct feedback and stimulating individual problem solving, and finding personal, realistic solutions. The standardised O&M training consists of two face‐to‐face sessions and one telephone session. Compared to the regular O&M training, the standardised O&M training is well structured, yet still tailor made as clients are actively involved in their rehabilitation with respect to mobility. For example, they are encouraged to individualise their training by means of formulating personal goals regarding activities in the community. Trainers were instructed to provide additional O&M training sessions to the clients if needed. Trainers providing care according to the standardised O&M training needed to complete both the two face‐to‐face sessions and the one telephone session before conducting extra training sessions on O&M. Trainers who would provide the standardised O&M training to the intervention group received a two hour instruction by the researcher (GZ). To prepare for the instruction, trainers read the manual of the standardised O&M training. To monitor whether participants received sufficient care, trainers answered two questions as part of the process evaluation. These questions included to what extent the O&M training met the participant's need for mobility support according to the perception of the trainer and whether additional training sessions in the use of the identification cane were needed.
Outcomes	ADL self care and visual functioning with respect to distance activities and mobility. Secondary outcomes include quality of life, feelings of anxiety, symptoms of depression, fear of falling, and falls history. Data for the effect evaluation are collected by means of telephone interviews at baseline, and at five and 17 weeks after the start of the O&M training. In addition to an effect evaluation, a process evaluation to study the feasibility of the O&M training is carried out.
Starting date	November 2007. Preliminary findings regarding the evaluation are expected in the course of 2010.
Contact information	GAR Zijlstra ‐ R.Zijlstra@zw.unimaas.nl; Maastricht University, Faculty of Health, Medicine and Life Sciences, Department of Health Care and Nursing Science, Maastricht, the Netherlands; CAPHRI School for Public Health and Primary Care, P.O. Box 616, 6200 MD Maastricht, the Netherlands
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