| Methods |
An RCT comparing LSS delivered through telecommunication technology vs the same training delivered face to face and with unstructured cognitive treatment in persons with early AD |
| Participants |
27 participants residing in daycare centres for the elderly in Venice, Italy, with a diagnosis of probable AD, according to NINCDS‐ADRDA, who were not on anti‐dementia drug therapy. Mean age of participants was 83.7, and they had received a minimum of 6 years of formal education. Twenty‐one were female and 6 were male. Participants are presumed to be community‐dwelling persons |
| Interventions |
Participants in the LSS‐direct intervention condition (n = 10) received face‐to‐face training on lexical tasks that aimed to enhance semantic verbal processing
Participants in the LSS‐telecondition (n = 7) received the LSS intervention through telecommunication
Participants in the control condition (n = 10) completed face‐to‐face exercises, such as practising manual skills or reading the newspaper and engaging in discussion
The same therapist delivered all interventions, which lasted for 3 months and included two 1‐hour small‐group sessions per week. Between sessions, caregivers were encouraged to deliver non‐specific cognitive reinforcement |
| Outcomes |
Primary outcomes were global cognitive performance, lexical‐semantic abilities, and episodic verbal memory
Secondary outcomes were changes in attention, working memory, executive functions, and visual‐spatial abilities
These domains were assessed by a neuropsychologist at baseline and after 3 months of treatment |
| Country |
Italy |
| Registration status |
No information provided; presumed to be unregistered |
| Conflict of Interests |
No |
| Notes |
We tried to contact study authors to ask for mean, SD, and sample size for Trail Making Test (A and B), NPI, and ROCF Copy Test at baseline and at post‐intervention assessment, but we received no reply |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
No information is provided regarding the method of randomisation. However, study authors state, "The unequal distribution among the three treatment groups was due to the preference of two patients, initially enrolled in the LSS‐tele group, to not be involved with computer technology and who were shifted into the other two treatment arms" |
| Allocation concealment (selection bias) |
High risk |
Two participants who were initially enrolled in the LSS‐tele group were then allocated to the other 2 conditions, with their preferences considered. For this reason, allocation concealment was not possible in these cases |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Study authors did not mention blinding of participants. They compared CT vs an active condition, so blinding may have been possible |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
All assessments were carried out by an experienced neuropsychologist who was blinded to the treatment group to which each participant was allocated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No outcome data were missing. No participants dropped out of the study; all were included in the analysis |
| Selective reporting (reporting bias) |
High risk |
Results of Trail Making Tests A and B (secondary outcome measures) were not reported |
| Other bias |
Low risk |
Study appears to be free of other sources of bias |
