Gitlin 2008.
| Study characteristics | ||
| Methods | Randomised controlled pilot study, registration number: NCT00259467 (retrospectively registered) Duration of follow‐up: 4 months Recruitment period: 2005 to 2006 |
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| Participants | Country: USA Participants were recruited via media announcements and social service mailings. Interested caregivers contacted the research office, were explained study procedures, and administered a telephone eligibility screening test. Inclusion criteria (participants): English‐speaking, a physician diagnosis or MMSE score < 24, able to feed self and participate in at least 2 self‐care activities (e.g. bathing, dressing) Exclusion criteria (participants): schizophrenia, bipolar disorder, or dementia secondary to head trauma, MMSE score 0, bed‐bound (confined to bed or chair), or non‐responsive (unable to understand short commands) Inclusion criteria (caregiver): English‐speaking, age ≥ 21 years, living with the participant, provides 4 h of daily care, report participant’s boredom, sadness, anxiety, agitation, restlessness, or trouble focusing on a task Exclusion criteria (caregiver): involvement in other studies, seeking nursing home placement, terminally ill, in active cancer treatment, or with 3 or more hospitalisations in the past year Number of participants completing the study: n = 56 (intervention group n = 27, control group n = 29) Age (mean ± SD) years: people with dementia: intervention group: 78.0 ± 9.2, control group: 80.8 ± 9.5; caregivers: intervention group 62.8 ± 11.3, control group: 67.9 ± 10.6 Gender (female): people with dementia: intervention group: 50.0%, control group: 36.7%; caregivers: intervention group: 83.3%, control group: 93.3% Cognitive status, MMSE (mean ± SD): intervention group 11.0 ± 7.3, control group 12.2 ± 8.8 Care dependency: Activities of daily living functioning (mean ± SD) (range 0 to 7): intervention group 4.6 ± 2.3, control group 4.37 ± 2.1 Relationship to the participant (spouse): intervention group 53.3%; control group 70.0% |
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| Interventions | Intervention: TAP, selection of tailored activities, preparation of an activity plan, and caregiver training and support to deliver the planned activities Control: usual care |
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| Outcomes | Primary: frequency of behaviour occurrence Secondary: person with dementia: number of behaviours occurring, depression, activity engagement, quality of life; caregiver: subjective burden, depression, activity mastery, confidence using activities, skill enhancement |
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| Funding | National Institute of Mental Health (grant no. R21 MH069425) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "(...) dyads were randomized using random permuted blocks to control for possible changes in subject mix over time. The blocking number, developed by the project statistician, remained unknown to others." |
| Allocation concealment (selection bias) | Low risk | Not clearly stated. Information from study authors: allocation was performed by the project statistician and was concealed. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not blinded to group allocation (not possible). Insufficient information to permit judgement of ‘low risk’ or ‘high risk' |
| Blinding of outcome assessment (detection bias) Subjective outcomes (participant‐rated) | High risk | Caregiver outcomes: family caregivers 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 | "Of 60 dyads at baseline, four (7%) terminated because of patient death." |
| Selective reporting (reporting bias) | Unclear risk | All described outcomes reported, but the study was registered retrospectively, and no study protocol is available. |
| Other bias | Low risk | |