Travers 2017.
Study characteristics | ||
Methods |
Study design: randomised controlled trial (ACTRN12613000296730) Duration of follow‐up: 8 weeks Study period: not reported |
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Participants |
Country: Australia Setting: four nursing homes, southern suburbs of Brisbane, Queensland, 48 to 126 beds. All catered for residents with high and low care needs and all were accredited with the National Accreditation Agency (Aged Care Standards and Accreditation Agency Ltd). The facilities were managed by religious (two), independent not‐for‐profit (one) and private (one) organisations and all facilities employed activities staff and provided a variety of organised activities for residents. Participants
Baseline characteristics
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Interventions |
Intervention: BE‐ACTIV Control: walking and talking intervention |
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Outcomes |
Primary (defined in the trial registration):
Secondary: agitation (CMAI ‐ short form) |
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Funding | Funded by the JO & JR Wicking trust | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The Project Coordinator assigned participants a unique study identification number and randomly allocated them to either the BE‐ACTIV or the Walking and Talking intervention using the SPSS randomization function." |
Allocation concealment (selection bias) | High risk | "The Project Coordinator assigned participants a unique study identification number and randomly allocated them to either the BE‐ACTIV or the Walking and Talking intervention using the SPSS randomization function." Not concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "In the first instance, facility staff (activities staff in particular) and volunteers were invited to attend two 90‐min depression training sessions that were conducted at the commencement of the study in each facility (...) An overview of the project including its rationale and methods was also provided." The therapist and the nursing staff was aware of the group allocation; no information about the blinding of the participants was reported. Since the same nurses cared for participants in both study groups there is a risk of contamination. We judged risk of performance bias to be high. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "The measures of QOL (QOL‐AD‐NH), and depression (GDS‐12R) were re‐administered following completion of the interventions by the Project Coordinator only, who was not blinded regarding participant’s group allocation." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Ten participants were allocated to the BE‐ACTIV intervention and nine to the Walking and Talking intervention. One resident who had been allocated to the Walking and Talking intervention, however, died prior to commencement of the intervention and his data were excluded from all analyses. All remaining participants completed the eight‐week interventions." |
Selective reporting (reporting bias) | Unclear risk | Only the primary outcomes defined in the trial register were reported. |
Other bias | Low risk | ‐ |