Clinical trial NCT06597981: Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers
Official title: Development and Testing of a Dyadic Empowerment-based Sport Stacking Program to Improve Health Outcomes of People with Mild Dementia and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Family Caregivers
Dyadic Intervention
Health Related Quality of Life
Cognition
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Global cognition
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Relationship quality
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Secondary outcomes:
measure: Memory function
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Processing speed and executive function
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Behavioral and psychological symptoms of dementia
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Expressed emotion
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Burden
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
measure: Compliance rate in sport stacking
timeFrame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
Study officials:
References: