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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612167
Recruitment Status : Suspended (no funding)
First Posted : August 2, 2018
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Chang Gung University of Science and Technology
Information provided by (Responsible Party):
Ling-Hui Chang, National Cheng Kung University

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.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Complaints Behavioral: cognitive intervention Behavioral: nutritional group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2022

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).




Primary Outcome Measures :
  1. The Mini-Mental State Examination [ Time Frame: 3 month ]
    cognition

  2. the Trail Making Test [ Time Frame: 3 month ]
    attention

  3. the Color Trail Test [ Time Frame: 3 month ]
    attention

  4. Rivermead Behavioral Memory Test [ Time Frame: 3 month ]
    memory

  5. the Contextual Memory Test [ Time Frame: 3 month ]
    memory

  6. the Digit Span test [ Time Frame: 3 month ]
    memory


Secondary Outcome Measures :
  1. Cognitive Failure Questionnaire and the [ Time Frame: 3 month ]
    perceived cognitive failures

  2. Everyday Memory Questionnaire [ Time Frame: 3 month ]
    perceived memory problems



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612167


Locations
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Taiwan
National Cheng-Kung University
Tainan, Taiwan, 701
Sponsors and Collaborators
National Cheng Kung University
Chang Gung University of Science and Technology
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Responsible Party: Ling-Hui Chang, Associate Professor, National Cheng Kung University
ClinicalTrials.gov Identifier: NCT03612167    
Other Study ID Numbers: 102-2717B
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: On-going research. Individual data will only share within the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No