Methods |
Design: 2‐arm randomised controlled pilot trial with parallel‐group design
Recruitment period: not reported
No. of centres involved: 6
Unit of randomisation: individuals
No. randomised: 223
Number of arms considered in this review: 2
Maximum trial duration: 9 months
Funding by non‐profit organisation: CADENZA, a Jockey Club Initiative for Seniors
Funding by commercial organisation: none described
Publication status: full‐text report
|
Participants |
Type of MCI: not addressed
Patient flow: 111 randomised, 111 described at baseline in experimental group; 112 randomised, 112 described at baseline in control group
Number of females: 97 of 111 (87%) in experimental group; 93 of 112 (83%) in control group
Average age (SD): 75 (5.8) years in experimental group; 75 (5.8) years in control group
Average (SD) education: no formal education 6 (5.4%); below or at primary level 84 (75.7%); secondary or above 21 (18.9%) in experimental group; no formal education 14 (12.5%); below or at primary level 72 (64.3%); secondary or above 26 (23.2%) in control group
Baseline cognitive function: measured with CMSS and CMMSE
Selection criteria on cognition: subjective memory complaints: score ≥ 3 on Chinese Memory Symptoms Scale (mean 4.2, SD 0.8 in experimental group; mean 4.0, SD 0.8 in control group); no dementia: score ≥ 20 on Chinese version of Mini Mental State Examination (mean 25.6, SD 2.5 in experimental group; mean 25.7, SD 2.5 in control group)
Ethnicity: 111 Asian in experimental group; 112 Asian in control group
APOE: number of participants positive for APOE not reported
|
Interventions |
Type of experimental intervention: computerised CT, treatment duration 12 weeks; intervention provided as group training, under supervision
Details of experimental intervention: CCT based on ACTIVE trial protocol, with focus on attention, memory, and reasoning
Type of concomitant treatment provided: none
Session duration: 90 minutes in experimental group
Number of treatment sessions: 12 in experimental group
Treatment frequency: 1/week in experimental group
Maximum treatment duration: 12 weeks in experimental group
Type of control intervention: other; treatment duration 12 weeks; intervention provided as group training, under supervision
Details of control intervention: "series of health‐related educational lectures in small groups on prevention of mood disorder, heart diseases, diabetes, and stroke"
Session duration: 90 minutes in control group
Number of treatment sessions: 12 in control group
Treatment frequency: 1/week in control group
Maximum treatment duration: 12 weeks in control group
|
Outcomes |
-
Cognitive functioning outcome considered
Physical functioning outcome considered: none
Quality of life outcome considered: none
Depression outcome considered: none
Safety outcome considered: none
-
Available cognitive functioning outcomes not considered in this review
CDRS subscale: attention at 12 weeks and 9 months on a scale from 0 to 37 with higher values indicating benefit
CDRS subscale: initiation/perseveration at 12 weeks and 9 months on a scale from 0 to 37 with higher values indicating benefit
CDRS subscale: construction at 12 weeks and 9 months on a scale from 0 to 6 with higher values indicating benefit
CDRS subscale: conceptualisation at 12 weeks and 9 months on a scale from 0 to 39 with higher values indicating benefit
CDRS subscale: memory at 12 weeks and 9 months on a scale from 0 to 25 with higher values indicating benefit
|
Notes |
Although Kwok 2013a measured global cognitive function at 9 months of follow‐up, they did not report data for the entire study population |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Judgement: method of allocation not reported Quote(s): "single‐blind randomized placebo‐controlled trial" |
Allocation concealment (selection bias) |
Unclear risk |
Judgement: method of allocation concealment not reported Quote(s): none |
Blinding of participants (performance bias) |
High risk |
Judgement: blinding not feasible Quote(s): none |
Blinding of physicians / personnel |
High risk |
Judgement: blinding not feasible Quote(s): none |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Judgement: outcome assessor explicitly reported to be blind Quote(s): "trained research assistant who was blind to treatment assignment" |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Judgement: 103 out of 111 (93%) randomised in experimental group were analysed, and 103 out of 112 (92%) randomised in control group were analysed. Fraction with missing data below 10% Quote(s): none; "the authors did not mention analyses to be in line with intent‐to‐treat principles, neither did they report on imputation techniques" |
Selective reporting (reporting bias) |
High risk |
Judgement: incomplete reporting of non‐significant outcome data for the overall group. For example, outcome data for the CDRS total score were not abstractable for the overall group but were reported for subgroups with low, moderate, or high educational baseline values |
Other bias |
Low risk |
Judgement: none detected |