| Methods |
Design: 2‐arm RCT with factorial design
Recruitment period: not reported
No. of centres involved: 1
Unit of randomisation: individuals
No. randomised: 155
Number of arms considered in this review: 2
Maximum trial duration: 3 months
Funding by non‐profit organisation: none reported
Funding by commercial organisation: NexSig Cognifit
Publication status: full‐text report
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| Participants |
Patient flow: 84 randomised, 84 described at baseline in experimental group; 71 randomized, 71 described at baseline in control group
Number of females: 56 of 84 (67%) in experimental group 1; 40 of 71 (56%) in control group 1
Average age (SD): 68 (8.3) years in experimental group 1; 67 (7.2) years in control group 1
Average (SD) education: 14.6 (2.8) years in experimental group; 15.1 (3.6) years in control group
Baseline cognitive function: MMSE 29.0 (SD 1.2)
Selection criteria on cognition overall: healthy
Ethnicity: not reported
APOE: number of participants positive for APOE not reported
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| Interventions |
Type of experimental intervention: computerised CT, individualised; treatment duration of 12 weeks; intervention provided as individual training, without supervision
Details of experimental intervention: the personalised cognitive training programme selected for this study was the CogniFit Personal Coach. This programme’s training regimen is based on the results of a baseline cognitive evaluation called the Neuropsychological Examination–CogniFit Personal Coach
Session duration: 20 to 30 minutes in experimental group
Number of treatment sessions: 36 in experimental group
Treatment frequency: 3/week in experimental group
Maximum treatment duration in weeks: 12 in experimental group
Type of control intervention: active computer; treatment duration of 12 weeks; intervention provided as individual training, without supervision
Details of control intervention: "twelve classic computer games that significantly engage cognitive processing were selected to create the computer games program. This program shared several features with the personalized cognitive training program, including the baseline cognitive evaluation, a total of 24 sessions comprising 3 different tasks, and a similar graphic design (Appendix 2). However, it did not have the adaptive training features of the personalized cognitive training program"
Session duration: 25 minutes in control group
Number of treatment sessions: 36 in control group
Treatment frequency: 3/week in control group
Maximum treatment duration in weeks: 12 in control group
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| Outcomes |
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Cognitive functioning outcomes considered
Global cognitive functioning measured with Overall score: NexAde battery at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Episodic memory measured with Memory recall at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Executive functioning measured with Executive functions at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Working memory measured with Visuospatial working memory at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Physical functioning outcome considered: none reported
Quality of life outcome considered: none reported
Safety outcome considered: none reported
Depression outcome considered: none reported
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Other outcome data on cognitive functioning, not considered in our meta‐analyses
Episodic memory measured with Memory recognition at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Episodic memory measured with Visuospatial learning at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Executive functioning measured with Focused attention at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Executive functioning measured with Mental flexibility at 3 months, on a scale from not reported to not reported with higher values indicating benefit
Working memory measured with Sustained attention at 3 months, on a scale from not reported to not reported with higher values indicating benefit
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| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Judgement: adequate random sequence generation Quote(s): "random number generator" |
| Allocation concealment (selection bias) |
Low risk |
Judgement: adequate method of allocation concealment Quote(s): "encrypted codes" |
| Blinding of participants (performance bias) |
High risk |
Judgement: a large number of participants correctly identified their group assignment; this is assumed to be an indication of poor blinding of participants Quote(s): "..with investigators and participants being blind to group assignment. Participants received a CD containing either the cognitive training program or the computer games program. To preserve blindness, all CDs were labelled and packaged identically, and all graphics, fonts, opening screens, baseline evaluations and post‐training evaluations were identical on both CDs. Personnel were kept unaware of the participants’ group assignment, which was encrypted in the code number labels on the CDs"; ""Thirty‐six percent of the subjects correctly identified their group assignment (21% personalized cognitive training, 15% games)" |
| Blinding of personnel (performance bias) |
Low risk |
Judgement: adequate method of therapist blinding Quote(s): "..with investigators and participants being blind to group assignment. Participants received a CD containing either the cognitive training program or the computer games program. To preserve blindness, all CDs were labelled and packaged identically, and all graphics, fonts, opening screens, baseline evaluations and post‐training evaluations were identical on both CDs. Personnel were kept unaware of the participants’ group assignment, which was encrypted in the code number labels on the CDs" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Judgement: not clearly reported if outcome assessors were blinded, but all personnel were likely kept blinded to treatment assignment Quote(s): "personnel were kept unaware of the participants’ group assignment, which was encrypted in the code number labels on the CDs" |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Judgement: for the outcome episodic memory, 66 out of 84 (79%) randomised were analysed in experimental group, and 55 out of 71 (77%) randomised were analysed in control group. Statistical analyses were reported to be done according to the intent‐to‐treat principle. Although study authors state that they used an ITT, 18 participants in experimental group and 16 in control group did not complete the training and had no data available at baseline, follow‐up, or both Quote(s): "a total of 34 (22%) participants (18 in the cognitive training group and 16 in the computer games group) did not complete the training; the majority of those (n = 29) never began the home training" |
| Selective reporting (reporting bias) |
Low risk |
Judgement: all outcomes indicated in the methods section are reported in the results section |
| Other bias |
Low risk |
Judgement: no other apparent risks of bias |