Clinical trial NCT03612167: Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
Official title: Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Subjective Cognitive Complaints
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Chang Gung University of Science and Technology
First posted: 2018-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-experimental design with nonequivalent control was adopted in a senior center. Experimental variable was a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Participants were allocated into intervention group (cognitive intervention group) and control group (nutrition education group). The group assignment depended on what group they signed up for participate.
Primary purpose: TREATMENT

Brief summary: Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.


Eligibility criteria: Inclusion Criteria:

1. Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.
2. Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.
3. Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.

Exclusion Criteria:

1. A confirmed diagnosis of dementia
2. With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.
3. With Mini Mental Status Exam \<=24 (education status beyond primary school); or \<=16 (No education)
4. With less than 10-session participation rate out of 12.

Primary outcomes:
measure: The Mini-Mental State Examination
timeFrame: 3 month
measure: the Trail Making Test
timeFrame: 3 month
measure: the Color Trail Test
timeFrame: 3 month
measure: Rivermead Behavioral Memory Test
timeFrame: 3 month
measure: the Contextual Memory Test
timeFrame: 3 month
measure: the Digit Span test
timeFrame: 3 month
Secondary outcomes:
measure: Cognitive Failure Questionnaire and the
timeFrame: 3 month
measure: Everyday Memory Questionnaire
timeFrame: 3 month
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References: