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

Hayden 2012.

Study characteristics
Methods Design: Randomised parallel trial.
No. of participating centres: One.
Study dates: 8/2007 to 6/2012.
Participants Inclusion criteria: Patient with a diagnosis of Alzheimer's disease under current treatment, living in community and ambulatory, with age 50‐95 years. Caregiver age 18‐90 years; patient and caregiver residing within 2 hours of Los Angeles; home Internet access.
Exclusion criteria: Patient living in residential setting; acute illness or chronic disease in patient or caregiver; patient or caregiver plans to leave area within the year.
No. of participants randomised to interventions:
‐ Caregiver website support (n = 29).
‐ Caregiver brief supportive phone calls (n = 24).
Baseline characteristics:
Caregivers: Mean age for participants was 67.4 years (SD = 11.6). Most caregivers were females (81%), partners or spouses of AD patients (60%).
Care recipients: Mean age was 81.1 years (SD = 7.4).
Interventions Experimental: Caregiver website support (customary care plus access to an intensive, interactive online education and support website information for 6 months).
Control: Caregiver brief supportive phone calls (customary care plus monthly brief telephone calls with project staff).
Length of intervention: 6 months.
Outcomes Primary outcomes:
‐ Caregiver burden assessed with the 12‐item Zarit Short Burden Scale. Range of scores from 12 to 60; higher scores mean greater caregiver burden.
‐ Patient problematic behavioral patterns assessed with the 24‐item Revised Memory and Behavior Problem Checklist (RMPBPC). Range of scores from 0 to 96; higher scores mean greater frequency of problematic behaviours.
‐ Caregiver negative reactions to problematic behavioral patterns assessed with the Negative Reactions Scale from the RMBPC. Range of scores from 0 to 96; higher scores mean greater degree of distress.
‐ Caregiver depression assessed with the 21‐item Beck Depression Inventory. Range of scores from 0 to 63; higher scores mean increased endorsement of depressive symptoms.
Secondary outcomes:
‐ Patient medication adherence.
‐ Number of participants placed in assisted living or nursing homes 12 months from baseline.
Outcomes assessment: At 6‐ and 12‐month post‐randomisation.
Notes Clinical trial registration code: NCT00416078.
Funding: Veteran's Affairs Health Services Research and Development (Grant IIR 05‐107).
Conflicts of interest: None declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Study described as randomised but without information on the randomization procedure.
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 cannot be blinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: There is no information on outcome assessment, but intervention components and procedures are not comparable with subjective participant‐reported outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: There is a high attrition rate but similar between arms. 11 of 29 participants (38%) dropped out from the experimental arm, 8 of 24 participants (33%) dropped out from the control arm.
Selective reporting (reporting bias) Low risk Comment: Trial registered at ClinicalTrials.gov (NCT00416078).
Other bias Low risk Comment: None detected.