Waterman 2016.
| Study characteristics | ||
| Methods | Study design: RCT Number randomized: 49 (16 in environmental group; 17 in environmental and behavior group, 16 in the control group) Number analyzed: 43 Number of centers: 1 Date of first enrollment: July 2011 Length of follow‐up: 6 months Sample size estimation: the author reported the intended sample size was 30 participants in each group (a simple randomization 1:1:1 ratio) allowing for 10% attrition rate. |
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| Participants | Country: UK Age: mean 81 years (SD: 8 years) Sex: 35% male, 65% female Key inclusion criteria: having a vision impairment (Binocular visual acuity >0.6 LogMAR, and/or moderate visual field loss defined as affecting more than 20% of the test locations used in a binocular Esterman test), living independently in community, being able to walk around own residence, cognitively able to participate and understand study requirements. Key exclusion criteria: receiving an OT or physiotherapist intervention or home safety assessment and modification or exercise intervention, including attendance at a Falls Clinic, not achieving between 7 and 10 on the Abbreviated Mental Test. Comparability of baseline characteristics: comparable |
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| Interventions |
Environmental intervention #1: participants received the Home Safety (HS) program implemented by an Occupational Therapist (OT). An experienced trained OT used an amended version of the Westmead Home Safety Assessment to discuss environmental hazards present in their homes with participants. This resulted in a jointly agreed action plan incorporating participant needs and views. The action plan focused on how the participant could alter their environment to reduce the likelihood of falls. Environmental and behavioral intervention #2: participants received the HS plus the home exercise programs both implemented by the OT and supported by a volunteer peer mentor. The HS was described above, the home exercise included the Otago Exercise Programme (OEP) for 6 months. The exercises, stressing both strength and balance, were individually prescribed, progress in difficulty, and were undertaken for 30 min at least three times per week. A walking plan was also agreed with all participants to be undertaken at least twice per week. Control intervention #3: usual care from the NHS, but in addition received three social visits and two telephone calls by lay visitors (volunteer student nurses, alumni and members of staff from the university) |
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| Outcomes | Primary outcome: number of falls at 6 months, number of injurious falls at 6 months. Secondary outcomes: (1) adherence rate, (2) self‐reported physical activity questionnaire (Phone‐FITT), (3) objective measures of physical activity (activPALTM activity monitor): daily step counts and walking time (minutes) (4) quality of life (12‐Item Short Form Health Survey), (5) visual disability (Vision‐Related Quality of Life), (6) attitudes to Falls‐Related Interventions Scale, (7) fear of falling (SFES‐I). |
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| Notes | Funding sources: National Institute for Health Research (NIHR) under the Research for Patient Benefit Programme (RfPB), reference number: PB‐PG‐0909‐20090. Statistical analyses: appropriate Subgroup analyses: not reported Registration: ISRCTN53433311 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were then independently randomized by the Clinical Trials Unit via a web‐based secure randomization service, which informed the Occupational Therapist or lay visitor coordinator of the group assignment |
| Allocation concealment (selection bias) | Low risk | Occupational Therapist and coordinator did not know the next assignment when implementing the randomization |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and the occupational therapist delivering the intervention, social visitors and peer mentors could not be blinded to group allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The research assistant and statistician were blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 43 of 49 (88%) participants completed 6‐month of follow‐up. Number of participants with follow‐up were equal between groups. No missing outcome data. Participants were phoned to ensure complete data set. |
| Selective reporting (reporting bias) | Low risk | Outcomes specified in the study protocol were reported |
| Other bias | Low risk | No other sources of bias identified |
FaME: Falls Management Exercise Phone‐FITT: Telephone questionnaire for self‐report of physical activity SFES‐I: Short Falls Efficacy Scale‐International EuroQoL: European Quality of Life PANAS: Positive and Negative Affect Scale GDS‐5: Geriatric Depression Scale‐5 Ashtanga‐based yoga therapy (AYT) OT: Occupational Therapist HS: Home Safety OEP: Otago Exercise Programme SF‐12: 12‐Item Short Form Health Survey