NCT Number: NCT07531082
Family caregivers of persons with dementia (PwD) are well known to be "invisible patients." Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. However, few interventions are available to enhance the SOC and thereby the emotional and psychological health of this population. While in-home social robots are viewed as a useful addition to caring for PwD, the use of social robots with family caregivers as the primary audience are vastly under-investigated. In response, the investigators have developed a strength-based, robot-assisted intervention based on Antonovsky's theory of saluotogenesis for family caregivers of PwD. The feasibility, acceptability, and preliminary effects of the robot on family caregivers of PwD have been confirmed, with recommendations for examining its applicability among this population in a full trial.
This study aims to examine the effects of a salutogenic strength-based, robot-assisted intervention on improving depressive symptoms in family caregivers of PwD. This is a mixed-methods study, including a prospective, single-blinded, two-arm parallel randomized controlled trial and semi-structured individual interviews. A group of 148 family caregivers of PwD will be randomized to the intervention group (IG) or the control group (CG), who will receive reading materials on dementia care weekly. Each IG participant will engage with a robot integrated with an AI-powered chatbot at home for 6 weeks. Individual interviews will be conducted at week-6. Purposive sampling will be used to ensure diversity among the participants. Descriptive statistics, t-test and/or Chi square test, generalized estimating equation (GEE), linear regression and thematic analysis will be used.
Primary hypothesis: Participants in the intervention group (IG) will report a greater improvement in depressive symptoms than the control group (CG) immediately postintervention at 6 weeks (T1), 1-month (T2) and 3-month (T3) after completing the intervention.
Secondary hypothesis: 1) Participants in the IG will report a greater improvement in SOC, perceived caregiving burden, coping, and caregiving self-efficacy than the CG at T1, T2, and T3; 2) The frequency of engaging with specific robot features is associated with improved depressive symptoms, SOC, caregiving burden, coping, and caregiving self-efficacy.
The findings may: 1) advance the understanding of the application of the salutogenesis theory to robotic technology, 2) boost the inner strength of family caregivers to maintain their emotional and psychological health in stressful situations, and provide a new paradigm to strengthen the informal care system.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A robot pre-set with a salutogenic strength-based intervention will be provided to participants. Each participant will receive a robot placed at home for 6 weeks, operating 24 hours a day and 7 days a week. Participants will be encouraged to engage with KaKa daily, for at least 90 minutes per week.
The group will be provided with reading materials on dementia caregiving weekly.
Time frame: From enrollment to 3-month (T3) after completing the intervention
will be assessed using the Chinese version of the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression. It scores each of the nine diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) for depression as "0" (not at all) to "3" (nearly every day) to assess depression and suicidal ideation in the past 2 weeks. The Chinese version of PHQ-9 has been validated in Hong Kong and was found to have a sensitivity of 80% and a specificity of 92% for diagnosing major depression (Yu et al., 2012).
Time frame: From enrollment to 3-month (T3) after completing the intervention.
will be measured using the Sense of Coherence Scale (Chinese version, C-SOC). It has 3 subscales measuring comprehensibility, manageability, and meaningfulness to an individual. A 1-7 Likert scale will be used, with higher scores indicating stronger SOC in each dimension. The Cronbach's alpha was 0.82, with good construct validity (Ding et al., 2012).
Time frame: From enrollment to 3-month (T3) after completing the intervention.
will be measured using the Simplified Coping Style Questionnaire.It measures on a 0-3 Likert scale the frequency with which positive (12 items) and negative (8 items) coping styles are used (Xie, 1989). A higher composite score represents more effective coping. The Cronbach's alpha was 0.90 and the 2-week test-retest reliability was 0.89 (Xie, 1989).
Time frame: From enrollment to 3-month (T3) after completing the intervention.
will be assessed using the 22-item Zarit Burden Interview (Chinese version; ZBI-C). It measures caregiving burden on health, psychological well-being, social life, finances, and care dyadic relationships. A 5-point response scale is used, with higher scores indicating a greater perceived burden. The Cronbach's alpha was 0.89, with good concurrent validity (Ko et al., 2008).
Time frame: From enrollment to 3-month (T3) after completing the intervention
will be measured using the Chinese version of the Revised Scale for Caregiving Self-efficacy.It consisted of 3 subscales (5 items per subscale), namely self-efficacy-obtaining respite (SE-OR), self-efficacy-responding to disturbing behaviors (SE-RDB), and self-efficacy-controlling upsetting thoughts (SE-CUT). The average scores of the subscales will be reported separately for each domain. The Cronbach's α for SE-OR, SE-RDB, and SE-CUT were 0.90, 0.93, and 0.92, respectively, for the pretest, and 0.91, 0.96, and 0.96, respectively, for the post-test (Au et al., 2009).
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
Acronym: social robot
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