Kwok 2013.
Study characteristics | ||
Methods |
Design: Parallel group randomised study. No. of participant centres: One, Hong Kong, China. Study dates: Recruitment between February 2011 and March 2012. |
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Participants |
Inclusion criteria: Caregivers of care recipients having clinical diagnosis of dementia of any stage, and being the primary caregivers. Exclusion criteria: Caregivers under the age of 18 years and those exhibiting intellectual impairment. No. of participants randomised to interventions: ‐ Telephone‐delivered psychoeducation group (n = 20). ‐ Control group (n = 22). Baseline characteristics: Caregivers: Most caregivers were female (71%), and spouse or child of patients (89%), 60% of caregivers presented an age between 31 and 50 years. Care recipients: Most patients were female (74%). |
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Interventions |
Experimental: A 12‐session psychoeducation program delivered by registered social workers over the telephone (approximately 30 minutes per session, one session per week). Control: DVD with educational information about dementia caregiving. Lenght of intervention: 12 weeks. |
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Outcomes |
Primary outcomes: ‐ Caregiver burden, measured by the Zarit Burden Interview (ZBI), (score range 0 to 88, higher scores indicate greater burden). ‐ Caregiver self‐efficacy, measured by the Revised Scale for Caregiving Self‐efficacy, (continuous scale from 0% to 100%, higher scores indicated greater sense of self‐efficacy). Secondary outcomes: ‐ Care recipients stage of dementia, indexed by the Global Deterioration Scale, (7 stages from 1 = no cognitive decline, to 7 = severe dementia). ‐ Care recipients cognitive functioning, assessed by the Abbreviated Mental Test. ‐ Behavioral problems of care recipients, measured by the participants using the Cohen–Mansfeld Agitation Inventory (scores range 29 to 203, higher scores indicate greater agitated behaviours). Outcomes assessment: At 12 weeks. |
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Notes |
Clinical trial registration code: Not reported. Funding: None declared. 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: "The participants were randomly assigned to either a psychoeducation group (intervention group) or a control group using a computerized randomization program." |
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: Interventions were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Pretests were carried out by a research assistant or by self‐administration of the caregivers. Post‐tests were administered to the participants approximately 3 months after pretest by a research assistant blind to the group assignment of the participants." Comment: Intervention components and procedures were not comparable throughout the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Ther is a low and non differential attrition: two participants of 20 (10%) dropped out from the intervention group, 2 participants of 22 (9.1%) dropped out from the control group. |
Selective reporting (reporting bias) | Unclear risk | Comment: There is no trial registration and/or available protocol. |
Other bias | Low risk | Comment: None detected. |