Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
The goal of this clinical trial is to develop and test a dyadic empowerment-based sport stacking program to improve health outcomes of people with mild dementia and their family caregivers.
The research hypotheses to be tested are:
i) People with dementia who receive the dyadic empowerment-based sport stacking program will report a greater improvement in cognitive function, a greater reduction in cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms, and a greater improvement in health-related quality of life (HRQOL) at T1 (12th week) and T2 (18th week), compared to the usual care group; ii) Caregivers who receive the dyadic empowerment-based sport stacking program will report less stressful in managing the cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms and a greater improvement in HRQOL at T1 (12th week) and T2 (18th week), compared to the usual care group; iii) The care dyads who receive the dyadic empowerment-based sport stacking program will report less dyadic relationship strain at T1 (12th week) and T2 (18th week), compared to the usual care group.
For the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads/group) and three check-up/support sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads/group). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes/day, five times/week) for 6 weeks.
Participants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads/group) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Dyadic empowerment-based sport stacking
BehavioralFor the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads/group) and three check-up/support sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads/group). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes/day, five times/week) for 6 weeks.
Basic education
Other interventionParticipants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads/group) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Dyadic empowerment-based sport stacking groupExperimental treatment 1 intervention
Group B: Basic education groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Health-related quality of life
The Short Form 12-item Health Survey-version two (SF-12v2) scale will be used to obtain the patient's health-related quality of life (HRQOL). The sum scores range from 0 to 100, with a higher score representing better HRQOL.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)2
Global cognition
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be used to evaluate global cognition. The sum scores range from 0 to 70, with a higher score representing poorer cognitive function.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)3
Relationship quality
The Dyadic Relationship Scales (Chinese version, DRS), which includes two independent scales (DRS-patient and DRS-caregiver versions) will be used to measure the quality of dyadic relationship between family dyads. The sum scores of DRS-patient range from 0 to 27 and the sum scores of DRS-caregiver range from 0 to 30, with a higher score representing poorer relationship quality.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)Secondary outcomes
1
Memory function
The Auditory Verbal Learning Task (AVLT) will be used to assess their memory.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)2
Processing speed and executive function
The Trail-Making Test (TMT) will be used to assess cognitive processing speed and executive function.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)3
Behavioral and psychological symptoms of dementia
The Neuropsychiatric Inventory (NPI), which was administered to the caregiver, will be utilized to assess the presence and severity of 12 common behavioral and psychological symptoms of dementia. The sum scores range from 0 to 144, with higher scores representing more severe neuropsychiatric behavioral symptoms.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)4
Expressed emotion
The 30-item Family Attitude Scale Chinese version (FAS-C) will be used to measure caregivers' expressed emotion. The sum scores range from 0 to 120, with a higher score representing higher levels of expressed emotion.
Time frame
baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)Sponsors and contacts
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Source ClinicalTrials.gov