Hayden 2012.
| Study characteristics | ||
| Methods |
Design: Randomised parallel trial. No. of participating centres: One. Study dates: 8/2007 to 6/2012. |
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| 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). |
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| 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. |
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| 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. |
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| Notes |
Clinical trial registration code: NCT00416078. Funding: Veteran's Affairs Health Services Research and Development (Grant IIR 05‐107). Conflicts of interest: None declared. |
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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 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. |