Huang 2003.
Methods | Randomised controlled trial, Pilot study. Study duration: 12 weeks. | |
Participants | 48 patients with dementia and their family caregiver (CG). Care recipients (CR) had to be aged 65 or over and score 50 or above on the CMAI. CRs were predominantly female with a mean age of 75.8 years. Twenty had a CDR rating of mild, 17 moderate, 10 severe and 1 very severe, with an average MMSE score of 13.1. CGs were predominantly female, with a mean age of 55.6. | |
Interventions | A home‐based Caregiver Training Programme Control (written materials only) Primary aim of intervention: To improve CG self efficacy and decrease CR problem behaviours. (See Table 2) |
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Outcomes | Chinese version of Cohen Mansfield Agitation Inventory (CMAI) (CR Frequency of problem behaviours & CG Self efficacy). | |
Notes | Country of origin: Northern Taiwan. 2 week in home training programme, plus telephone consultations every two weeks.The control group received educational materials and social telephone follow‐ups every two weeks. At the third week and third month assessments were conducted. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 'Randomly assigned to intervention or control group' |
Allocation concealment (selection bias) | Unclear risk | Randomised by patient registration number, odd registration numbers to intervention, even to control. The paper does not report who performed randomisation, |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'Although caregivers knew they were in a study, they did not know whether they were in the experimental or control group'. A manual was developed by the research team as a guide for the training program. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Investigator ran the intervention, unclear as to level of blinding and who conducted assessments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported (11 participants were lost to follow‐up because either the caregiver was unwilling to continue, the patient was hospitalised or the address was changed). |
Selective reporting (reporting bias) | Low risk | All results reported. |
Other bias | Unclear risk | None determined. |