Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dyadic empowerment-based sport stacking, Basic education.
- Who it may be relevant to
- Registry conditions: Dementia, Family Caregivers, Dyadic Intervention, Health Related Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Behavioral Dyadic empowerment-based sport stacking
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 s - Other Basic education
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).
Primary outcome measures
- Health-related quality of life [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Global cognition [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Relationship quality [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
Secondary outcome measures (6)
- Memory function [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Processing speed and executive function [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Behavioral and psychological symptoms of dementia [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Expressed emotion [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Burden [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
- Compliance rate in sport stacking [Time frame: baseline before randomization (T0), intermediate test at 12 weeks (T1), and post-test at 18 weeks (T2)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital of Chongqing Medical University — Chongqing
Identifiers
NCT: NCT06597981 · UW 24-395