Amieva 2016.
Methods | Multicentre RCT. | |
Participants | 653 community‐dwelling people who attended day centres or memory clinics in France, diagnosed with AD, 16‐26 on MMSE, 2‐5 on GDS, and with an identified family carer. 326 participants were in groups relevant to this review. Mean age: 78.75 years |
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Interventions | Intervention 1: group RT. Control: treatment as usual. Intervention 2: cognitive training (not included in the current review). Intervention 3: individual cognitive rehabilitation (not included in the current review). |
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Outcomes | Quality of life: QoL‐AD. Cognitive: MMSE, ADAS‐Cog. Behavioural: DAD, AGGIR. Mood‐related outcomes: Apathy Inventory, MADRS. Carer outcomes: ZBI. |
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Length and frequency of intervention | 1 × 90‐minute session per week for the first 3 months, and once every 6 weeks for next 21 months. | |
Time points measured | Baseline, 3 months' postbaseline (i.e. after the weekly sessions) and 24 months' postbaseline (i.e. after 6 weekly sessions). (MMSE and GDS measures only taken/reported at 24 months). |
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Number of participants who did not complete study | 56/326 (17.18%). | |
Notes | Primary outcome was rate of participants alive and without moderately severe to severe dementia at 2 years. The NPI was also used. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The list of randomization was prepared by a statistician using permuted blocks, stratified by site." |
Allocation concealment (selection bias) | Low risk | Participants randomised through an independent and remote telephone randomisation service provided by the clinical trial unit. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All assessment interviews done by physicians and psychologists blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 33 dropouts from RT and 23 from control group. Paper distinguished between participants who died and participants who withdrew, though specific reasons for these withdrawals were not reported. Results from a 'Missing Equals Failure' analysis was carried out. |
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 | All therapists received a 3‐day training session where the therapy programmes were thoroughly presented. Therapists were given contact details for the researchers who designed the programmes so they could contact them if necessary. |
Availability of manual or protocol for intervention All outcomes | Low risk | "Each therapy program was developed according to current scientific data, standardized by a leader known to have scientific and clinical expertise in the field. To guarantee homogeneity in the way interventions were applied, a standardized procedure was followed." Therapists were given a manual detailing the intervention. |