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

Czaja 2013.

Study characteristics
Methods Design: Parallel randomised study.
No. of participating centres: Recruitment from a variety of sources (memory disorder clinics, social service agencies, churches, community centres, newspaper advertisements, and community presentations).
Study dates: Not reported.
Participants Inclusion criteria: Caregivers 21 years or older, living or sharing cooking facilities with the patient, and having had provided care for a minimum of 4 hours/day for at least the past 6 months. Having a telephone, planning to remain in the area for at least 6 months, and competency in either English or Spanish. Dementia patients (physician diagnosis of AD or other dementia) with a MMSE score < 24 and presenting at least one limitation in activities of daily living, or two limitations in instrumental activities of daily living.
Exclusion criteria: Caregiver or patient presenting an illness or disability that would prohibit participation, or if the patient had an MMSE score of 0 and was bedridden.
No. of participants randomised to interventions:
‐ Technology‐based multi‐component psychosocial intervention (n = 38).
‐ Attention control (n = 36).
‐ information alone (n = 36)
Baseline characteristics:
Caregivers: Mean age for participants was 60.2 years (SD = 13.0). Most caregivers were females (84%), spouses, sons or daughter of patients (88.2%). On average caregivers had been providing care for 5.6 years (SD = 5.2).
Care recipients: Mean age for patients was 79.5 years (SD = 9.4). Patients had average scores of about 11.
Interventions Experimental: Technology‐based multi‐component standardised psychosocial intervention including six 1‐hour monthly sessions, two in‐home sessions, and four sessions delivered by videophone.
Control:
‐ Attention control condition: Participants received the same amount of contact as those in the intervention condition but the content was structured around nutrition and healthy eating.
‐ information alone: Participants received a packet of educational materials (basic information about dementia, caregiving, safety, and community resources) and a brief (< 15 minute) telephone "check‐in call" at 3 months post randomization.
Length of intervention: 5 months.
Outcomes Primary outcomes:
‐ Depression, assessed with CES‐D (score range 0 to 30, higher scores denote more depressive symptoms).
‐ Burden, assessed with the Revised Memory and Behavior Problems Checklist (RMBPC), (score range 0 to 96, higher scores represent higher perceived stress).
‐ Positive aspects of caregiving (9‐item instrument; score range 0 to 36, higher scores indicate more positive feelings about caregiving).
‐ Social support (10‐item instrument; responses scored on a 4‐point scale, 0 = never to 3 = very often).
Secondary outcomes: None stated.
Outcomes assessment: At 5‐month.
Notes Clinical trial registration code: Not reported.
Funding: Langeloth Foundation, Cisco Corp., AT&T, and the Administration on Aging.
Conflicts of interest: None declared.
Other: Results report combined data for both control groups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Study described as randomised, however no information on the randomization procedure is described.
Allocation concealment (selection bias) Unclear risk Comment: No information on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: Interventions cannot be blinded to participants.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "A certified assessor blind to group assignment administered the follow‐up assessment".
Comment: The information‐only control group presents components and procedures not comparable to the rest of trial arms. Unmasked study with participants not blind to interventions and subjective participant‐reported outcomes.
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: Differential drop out rates by treatment arms. Two participants of 38 (5.3%) dropped out from the intervention arm, 2 participants of 36 (5.5%) dropped out from the attention control arm, but 7 participants of 36 (19.4%) dropped out from the control intervention.
Selective reporting (reporting bias) Unclear risk Comment: There is not clinical trial registration and/or available protocol.
Other bias Low risk Comment: None detected.