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. 2021 Jan 4;2021(1):CD006440. doi: 10.1002/14651858.CD006440.pub3

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.
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%).
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.
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.
Notes Clinical trial registration code: Not reported.
Funding: None declared.
Conflicts of interest: None declared.
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.