Azcurra 2012.
Methods | RCT. | |
Participants | 135 participants from privately funded nursing homes in Argentina, with a diagnosis of AD according to DSM‐IV. 90 participants were in groups relevant to the current review. Mean age: 85 years. |
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Interventions | Intervention 1: group RT. Control: unstructured social contact. Intervention 2: counselling (not included in the current review). |
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Outcomes | Quality of life: SR‐QoL, WIB. Communication: SES. Behavioural: ADL scale. Carer: ZBI. |
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Length and frequency of intervention | 1 hour twice per week for 12 weeks. | |
Time points measured | Paper stated, "The data were collected at baseline (T0), twelve weeks (T1), and six months post‐intervention (T2)." | |
Number of participants who did not complete study | 5/90 (5.56%). | |
Notes | Some participants were on psychotropic medication and physically restrained. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised block design. Participants meeting enrolment criteria were randomly allocated to 1 of 3 groups by the assignment of a unique kit number using a permuted block design at each investigational site (block size of 6) (stated by e‐mail). |
Allocation concealment (selection bias) | Low risk | Paper reported, "we used an appropriate method of randomisation with adequate concealment of the participant allocation to treatment groups." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Independent raters (social workers) completed outcome measures blinded to group allocation. The facilitators carrying out the intervention blinded to the outcome measures. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis. Missing data replaced with the mean value of the outcome variables for each group. Withdrawals due to death, moving and believing their allocated condition (control) was "useless." |
Selective reporting (reporting bias) | Low risk | All outcomes listed in the methods section were reported and there was no evidence of selective outcome reporting. |
Other bias | Low risk | n/a. |
Availability of training and supervision Objective outcome measures | Low risk | Team trained by principal investigator to deliver the corresponding sessions in a structured manner. Facilitators had 15 training sessions totalling 30.4 hours. |
Availability of manual or protocol for intervention All outcomes | Low risk | Clear protocols developed in the training sessions. |