Kajiyama 2013.
Study characteristics | ||
Methods |
Design: Parallel group randomised study. No. of participant centres: One, in Stanford; USA. Study dates:From May 2011 to January 2012. |
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Participants |
Inclusion criteria: Caregivers at least 21 years of age or older; caring for an individual with a clinical diagnosis of dementia; and with access to the Internet on any type of computer or had access to a DVD player. Exclusion criteria: Caregivers that scored > 30 on the CES‐D scale; and if they were engaged in caregiving activities for less than an average of 8 hours/week. No. of participants randomised to interventions: ‐ iCare protocol (ICC) (n = 75). ‐ Education/Information‐Only Condition (EOC) (n = 75). Baseline characteristics: Caregivers: Mean age for participants was 56.1 years (SD = 11.4). Most were female (83%) , spouse, partner or child of the patient (89%). The mean number of hours of care was 66.9 hours per week (SD = 40.6). The mean score for CES‐D was 15.9 (SD = 8.0). Care recipients: Mean age for patients was 77.8 years (SD = 9,9). |
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Interventions |
Experimental: iCare Condition (ICC), online iCare Stress Management e‐Training Program developed from the "Coping with Caregiving" program. Control: Education/Information‐Only Condition (EOC). Participants were exposed to a website containing similar navigational features, but with content focused on information about dementia. In addition, links to video‐taped information were provided. Written materials from various health agencies were also provided in a booklet format. Thus, extensive information using ‘state‐of‐the‐art’ media strategies was made available to these participants, but without a format designed to enhance the development of specific skills to deal with stress from caregiving. Lenght of intervention: 3 months. |
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Outcomes |
Primary outcomes: ‐ Caregiver stress, assessed by the 10‐item Perceived Stress Scale (PSS) (range scores 0 to 40, higher scores denote more perceived stress. Secondary outcomes: ‐ Caregiver level of bother due to disruptive behaviours, assessed by the Revised Memory and Behavior Problems Checklist (RMBPC) (range scores 0 to 96, higher scores denote more perceived stress). ‐ Caregiver level of depression, assessed by the Center for Epidemiologic Studies Depression Scale (CES‐D) (range scores 0 to 30, higher scores denote more depressive symptoms). ‐ Quality of life, assessed by the Perceived quality of life (PQoL). Outcomes assessment: At 3 months. |
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Notes |
Clinical trial registration code: NCT01378195. Funding: National Institute on Aging (Award No. R44AG032762). 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 there is no 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: Intervention cannot be blinded to participants and/or personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: Outcome assessment was done by self‐report questionnaires, but Intervention components and procedures were not comparable. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: High level of attrition and also differential. 29 participants of 75 randomised to intervention (38.7%) were lost to follow up, 18 participants of 75 randomised to control intervention (24%) were lost to follow up. |
Selective reporting (reporting bias) | Low risk | Comment: This is a registered trial (NCT01378195). Article include the outcomes recorded in the trial registration. |
Other bias | Low risk | Comment: None detected. |