Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change from baseline caregiving demands at 4 and 10 months |
Measured by the Caregiver Burden Scale. This scale comprises 26 items on seven subscales measuring support for care recipient's activities of daily living, burden of behavioral and psychological symptoms, concern about future caregiving burden, lack of informal support, lack of formal support, caregiving interference with other roles, and financial burden of caregiving. Higher scores indicate worse outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Other |
Usability of the intervention |
Measured by 10 items. Scale scores range from 10 to 50, where higher scores indicate higher levels of perceived usability of the intervention (i.e., better outcome). |
Immediately after the intervention |
|
| Other |
Change from baseline care recipient's cognitive function at 3 and 6 months |
Measured by the Montreal Cognitive Assessment. This instrument is a cognitive screening test for the detection of mild cognitive impairment and Alzheimer's disease. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings. |
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up) |
|
| Other |
Change from baseline care recipient's depression at 3 and 6 months |
Measured by the Japanese version of the Geriatric Depression Scale Short Version. This scale comprises 15 items, ranging from 0 to 15. Higher scores indicate worse outcome. This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings. |
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up) |
|
| Other |
Change from baseline care recipient's psychological distress at 3 and 6 months |
Measured by the Stress Response Scale. This scale comprises 18 items on three subscales: depression/anxiety, irritability/anger, and helplessness. Scale scores range from 0 to 18 for each subscale. Higher scores indicate worse outcome. This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings. |
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up) |
|
| Other |
Baseline care recipient's cognitive function |
Measured by the Mini-Mental State Examination. This instrument is a cognitive screening test for the detection of dementia. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of a face-to-face setting. |
Baseline |
|
| Other |
Baseline care recipient's cognitive function |
Measured by the Hasegawa Dementia Scale-Revised. This instrument is a cognitive screening test for the detection of dementia. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of an online setting. |
Baseline |
|
| Primary |
Change from baseline depression and anxiety at 4 and 10 months |
Measured by the Hospital Anxiety and Depression Scale. This scale comprises two seven-item subscales: depression and anxiety. Scale scores range from 0 to 21 for each subscale, where higher scores indicate worse outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Primary |
Change from baseline quality of life (QOL) at 4 and 10 months |
Measured by the WHOQOL26. This scale comprises 26 items on four subscales: physical domain, psychological domain, social relationships, environment, and general health/QOL. Scale scores range from 7 to 35 for physical domain, 6 to 30 for psychological domain, 3 to 15 for social relationships, 8 to 40 for environment, and 2 to 10 for general health/QOL. Higher scores indicate better outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline subjective burden at 4 and 10 months |
Measured by the Zarit Burden Interview. This scale comprises 22 items, ranging from 0 to 88. Higher scores indicate worse outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline positive aspects of caregiving at 4 and 10 months |
Measured by the Cognitive Caregiving Appraisal Scale. This scale comprises 26 items on three negative appraisal subscales (feelings of restriction of social life, anxiety about continuing caregiving, and distress of the relationships with others) and three positive appraisal subscales (fulfillment of caregiving roles, affection toward the caretakers, and self-growth by caregiving). Positive appraisal subscales are used. Scale scores range from 6 to 24 for fulfillment of caregiving roles, 4 to 16 for affection toward the caretakers, and 3 to 12 for self-growth by caregiving. Higher scores indicate better outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline caregiving self-efficacy at 4 and 10 months |
Measured by the Revised Scale for Caregiving Self-efficacy. This scale comprises 15 items on three subscales: obtaining respite, responding to disruptive behaviors, and controlling upsetting thoughts. Scale scores range from 0 to 100 for each subscale, where higher scores indicate better outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline experiential avoidance in caregiving at 4 and 10 months |
Measured by the Experiential Avoidance in Caregiving Questionnaire. This scale comprises 15 items on three subscales: active avoidant behaviors, intolerance of negative thoughts and emotions, and apprehension concerning negative internal experiences related to caregiving. Scale scores range from 6 to 30 for active avoidant behaviors, 4 to 16 for intolerance of negative thoughts and emotions, and 5 to 25 for apprehension concerning negative internal experiences related to caregiving. Higher scores indicate worse outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline commitment to values at 4 and 10 months |
Measured by the Values Questionnaire. This scale comprises 10 items on two subscales: obstruction and progress. Scale scores range from 0 to 30 for each subscale. Higher scores for the obstruction indicate lower commitment (i.e., worse outcome), and higher scores for the progress indicate higher commitment (i.e., better outcome). |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
|
| Secondary |
Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months |
Measured by the Neuropsychiatric Inventory Questionnaire. This scale comprises 12 items measuring various BPSD. Participants (i.e., family caregivers) rated state of their care recipient. Scale scores range from 0 to 60, where higher scores indicate worse outcome. |
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) |
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