NCT06597981 Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers
| NCT ID | NCT06597981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2024-09-19 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: \- People living with dementia (PLwD) : i) Clinical diagnosis of dementia, in accordance with the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-V); ii) a minimum age of 60 years; iii) Clinical Dementia Rating (CDR) score of 1; iv) home-dwelling; v) able to communicate with the research personnel to understand training program and assessments; vi) have adequate hearing and visual function to enable skill learning; vii) informed consent. \- Family caregivers: i) aged 18 years or above; ii) living with or providing care to PLwD at least 4 hours/day; iii) able to understand and communicate in Chinese; iv) have access to smartphone/iPad/laptop and are users of one of these devices; v) consent to participate. Exclusion Criteria: \- People living with dementia (PLwD) : i) severe mental and behavioral disorders; ii) any acute medical condition precluding participation in the program (e.g., pneumonia and cardiac insufficiency); iii) concurrent participation in other studies. \- Family caregivers: i) physically not able to participate in the sport stacking due to physical problems; ii) suffer from acute psychotic condition; iii) unable to support the PLwD in the delivery of sport stacking sessions.
Frequently Asked Questions
Who can join the NCT06597981 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06597981 currently recruiting?
Yes, NCT06597981 is actively recruiting participants. Visit ClinicalTrials.gov or contact The University of Hong Kong to inquire about joining.
Where is the NCT06597981 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06597981 clinical trial?
NCT06597981 is sponsored by The University of Hong Kong. The trial plans to enroll 144 participants.