Clemson 2004.
Study characteristics | ||
Methods | RCT. Randomised in blocks of 4 stratified by sex and number of falls in previous 12 months | |
Participants | Setting: Sydney, Australia N = 310 Sample: volunteer community‐dwelling men and women recruited by various strategies (74% women) Age (years): mean 78 (SD 5) Inclusion criteria: aged ≥ 70; community‐dwelling; fallen in past year or felt themselves to be at risk of falling. Exclusion criteria: dementia (> 3 errors on Short Portable Mental Status Questionnaire); homebound; unable to independently leave home; unable to speak English | |
Interventions | Both groups received baseline assessment at home before randomisation 1. Stepping On programme. Multifaceted small‐group (N = 12) learning environment to encourage self efficacy, behaviour change, and reduce falls using decision‐making theory and a variety of learning strategies. Facilitated by OT. 2 hours per wk, for 7 wks; taught exercises and practised in classes. OT home visit within 6 wks of final programme session; booster session 3 months after final session. 2. Control: at least 2 social visits from student OT with no discussion of falls or fall prevention |
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Outcomes | 1. Rate of falls 2. Number of people falling | |
Duration of the study | 14 months | |
Notes | Details of programme in Appendix A of Clemson 2004: risk appraisal, exercise, moving safely, home hazards, community safety, footwear, vision and falls, vitamin D, hip protectors, medication management, mobility mastery, review and plan | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomised by researcher not involved in subject screening or assessment". Method not described. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Study participants and personnel not blinded, but staff visiting control group instructed not to discuss falls or fall prevention |
Blinding of outcome assessment (detection bias) Falls and fallers | Unclear risk | All participants used monthly calendar; telephone contact if not returned in 2 weeks. Blinding of study personnel recording data from the calendars not described. |
Incomplete outcome data (attrition bias) Falls | Unclear risk | SeeAppendix 3 for method of assessment. Insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) Fallers | Low risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | Low risk | Prospective. Monthly falls postcard calendar. |