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. |
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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. |
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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. |
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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. |
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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. |
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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. |