Novelli 2018.
| Study characteristics | ||
| Methods | Randomised controlled pilot study, not registered Duration of follow‐up: 4 months Recruitment period: 2013 to 2014, no further information about the complete study period reported |
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| Participants | Country: Brazil Participants were recruited through media announcements in the city of Santos, a large seaside city in the Southeast of Brazil. Interested caregivers contacted the research team by phone and were screened for eligibility. Inclusion criteria: participants with dementia: age 60 years or older, diagnosis of dementia according to National Institute on Aging‐Alzheimerʼs Association criteria, able to perform at least 2 basic activities of daily living (e.g. bathing, grooming, and dressing), presence of ≥ 2 behavioural and psychological symptoms of dementia in the last 30 days, being under stable pharmacological treatment for at least 3 months. Caregivers: age 18 years or older, provide at least 4 hours of daily care, willing to learn to use activities during care. Exclusion criteria: person with dementia was non‐responsive to short commands, confined to bed, terminally ill (e.g. advanced cancer), had more than 2 hospitalisations in the last year, was involved in other intervention studies, or if caregiver was seeking nursing home placement within the study period Number of participants completing the study: n = 30 (intervention group n = 15, control group n = 15) Age (mean ± SD) years: participants with dementia: intervention group 79.4 ± 7.72, control group 83.49 ± 7.13; caregivers: intervention group 64.33 ± 6.76, control group 68.16 ± 12.61 Gender, female: participants with dementia: intervention group 46.66%, control group 53.33%; caregivers: intervention group 93.33%, control group 73.33% Cognitive status MMSE (mean ± SD): participants with dementia: intervention group 19.0 ± 5.9, control group 23.82 ± 6.73 Relationship to the participant (spouse): intervention group 53.4%, control group 53.32% |
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| Interventions | Intervention: Tailored Activity Program – Brazilian version (TAP‐BR) Control: waiting‐list control group with usual care |
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| Outcomes | Primary: behavioural symptoms Secondary: quality of life of participants with dementia, caregivers' quality of life, caregiver burden, caregiver distress |
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| Funding | São Paulo Research Foundation, grant number 2013/02489‐7 | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The 30 dyads were randomized to an EG and a CG, by randomization in blocks of 4 generated by a computer, performed by a blinded research assistant." |
| Allocation concealment (selection bias) | Low risk | "The 30 dyads were randomized to an EG and a CG, by randomization in blocks of 4 generated by a computer, performed by a blinded research assistant." |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not blinded to group allocation (not possible) "To strengthen treatment fidelity, the occupational therapy interventionists (n=7) received 24 hours of training. The training involved lectures and role‐play sessions by a master trainer certified in the TAP program. Interventionists were closely supervised by the study coordinator and participated in biweekly meetings to review cases and troubleshoot implementation challenges." Insufficient information to permit judgement of ‘low risk’ or ‘high risk' |
| Blinding of outcome assessment (detection bias) Subjective outcomes (participant‐rated) | High risk | Participants and family caregivers (caregiver outcomes) were not blinded to group allocation. |
| Blinding of outcome assessment (detection bias) Subjective outcomes (proxy‐rated) | High risk | Subjective outcomes, and assessors (family caregivers) were not blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "With regard to the total sample, there was a 2‐dyad sample loss at the start of the TAP‐BR application, because of subject desistance, and 2 new dyads were included in this group; hence, the final sample was of 15 dyads in each group. There was no loss in the CG because retention strategies were applied. The dyads were contacted bimonthly and inquired about their general well‐being. There was no sample loss in the postintervention evaluation." |
| Selective reporting (reporting bias) | Unclear risk | Trial was not registered, and no study protocol is available. |
| Other bias | Unclear risk | Comment: pronounced baseline differences between groups for several outcomes. These differences might have occurred due to selection bias or by chance due to the small sample size. |
MMSE: Mini‐Mental State Examination SD: standard deviation TAP: Tailored Activity Program