Clinical trial NCT06090188: Culture-Based Multicomponent Cognitive Training Program
Official title: Feasibility of a Culture-Based Multicomponent Cognitive Training Program in Older People With Dementia: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Lead sponsor: National Tainan Junior College of Nursing
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To provide care without exacerbating behavioral and psychological problems and preventing functional decline, a multi-component, cognitive training program was designed. The purpose of this study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods.

Detailed description: The purpose of the study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods. This study was a 4-month cluster-randomized controlled trail. Participants who met sample selection criteria were recruited and assigned to either the experimental group or the comparison group, depending on the day-care center they attended. Subjects in the experimental group were received with the multi-component, cognitive training program (MCCTP) via research assistants (RAs) and caregivers of day care center for 8 weeks, then provide by caregivers of day care center for 8 weeks, as well as RAs provided assistance for activity process.

Eligibility criteria: Inclusion Criteria:

1. persons aged 60 years and over, (2) living in their own home, (3) with or without a hearing device and able to speak Mandarin or Taiwanese, (4) attending a day care centre at least three days per week, (5) cognitively impaired as determined by a score of 22 or lower on the Mini-Mental State Examination (MMSE), and (6) self or legal proxy agreed to participate in the study.

Exclusion Criteria:

- Persons were excluded if they were bedridden and unable to sit in a wheelchair or had one or more acute illnesses during the data collection period causing them to be unable to return to the day care centre.

Primary outcomes:
measure: Cognitive function
timeFrame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
measure: Behavioural problems
timeFrame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
measure: Symptoms of depression
timeFrame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
measure: Self-care abilities
timeFrame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Ah Lian Day Care Center
city: Tainan city
country: Taiwan
facility: Anping Day Care Center
city: Tainan city
country: Taiwan
facility: Huishan community long-term care institution
city: Tainan city
country: Taiwan
facility: Meiyu East District Day Care Center
Study officials:
References: