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. |
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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). |
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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. |
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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. |
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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. |
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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. |