Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults

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.

Study Overview

• Status: Suspended
• Conditions: Subjective Cognitive Complaints
• Intervention / Treatment: Behavioral: cognitive intervention; Behavioral: nutritional group

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng-Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multi-modal cognitive intervention; 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.	Behavioral: cognitive intervention; 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.
Active Comparator: nutritional group; A quasi-experimental design with nonequivalent control was adopted in a senior center. The intervention for control group was a 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).	Behavioral: nutritional group; 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mini-Mental State Examination	cognition	3 month
the Trail Making Test	attention	3 month
the Color Trail Test	attention	3 month
Rivermead Behavioral Memory Test	memory	3 month
the Contextual Memory Test	memory	3 month
the Digit Span test	memory	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Failure Questionnaire and the	perceived cognitive failures	3 month
Everyday Memory Questionnaire	perceived memory problems	3 month

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 102-2717B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On-going research. Individual data will only share within the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No