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. 2021 Jan 4;2021(1):CD006440. doi: 10.1002/14651858.CD006440.pub3

Nunez‐Naveira 2016.

Study characteristics
Methods Design: Multicentre, multinational parallel randomised study.
No. of participating centres: Several centres from Spain (n = 2), Denmark (n = 2), and Poland (n = 4).
Study dates: Not reported.
Participants Inclusion criteria: Taking care of a person diagnosed with dementia by a specialist or a neurologist according to standardised criteria (ICD‐10, DSM‐IV‐TR, NINCDS‐ADRDA), being the primary caregiver, and suffering burden according to the ZBI 22‐item scale (total score of 24 or more).
Exclusion criteria: To present conditions that might prevent the evaluation of the participant or the interaction with the platform: cognitive impairment, illiterate, severe hearing and visual or motoric problems.
No. of participants randomised to interventions:
‐ Application understAID (n = 36).
‐ Control (n = 41).
Baseline characteristics:
Caregivers: Mainly women (64%) with a mean ZBI score of 44.92 (SD = 11).
Care recipients: The most frequent GDS stages were GDS4 (31%) and GDS5 (36%), followed by GD6 (26.2%) whereas only 6.6% were severely demented (GDS7).
Interventions Experimental: The understAID application developed as an information and communication technology (ICT) and accessible through any device with Internet connection.
Control: Participants in the control group did not use the application and maintained their usual lifestyle.
Length of intervention: 3 months.
Outcomes Primary outcomes:
‐ Depressive symptoms, assessed by the CES‐D scale (score range 0 to 60, higher scores indicate more depressive symptoms).
‐ Sense of competence, assessed with the Caregiver Competence Scale (CCS), (maximum score of 16 points, higher scores indicate more feelings of competence).
‐ Caregiving satisfaction, assessed with the Revised Caregiving Satisfaction Scale (RCSS), (maximum score of 30 points, higher scores indicate more feelings of satisfaction).
Secondary outcomes: None stated.
Outcomes assessment: At 3 months.
Notes Clinical trial registration code: Not reported.
Funding: European Comission grant no. AAL‐2012‐5‐107, and national funding agencies from Spain, Denmark, and Poland.
Conflicts of interest: None declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were randomly assigned to the experimental or to the control group by using a computer‐based random number generator."
Allocation concealment (selection bias) Unclear risk Comment: There is no information on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: Participants and personnel were not blinded to interventions.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: Outcome assessors were not blind and intervention components and procedures are not comparable..
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: Differential attrition. Six participants of 36 (16.7%) dropped out from the experimental group, 10 participants of 41 (24.4%) dropped out from the control group.
Selective reporting (reporting bias) Unclear risk Comment: There is not clinical trial registration and/or available protocol.
Other bias Low risk Comment: None detected.