NCT03900156

Brief Summary

This is a 5-year project. In the 1st year of this study, a pilot randomized controlled trial evaluating the feasibility and acceptability of a goal-setting behavior change intervention aim at reducing modifiable risk factors for preventing cognitive decline. The aim of 2nd to 5th year of this study to investigate whether this multidomain intervention to optimize self-management of cognitive decline risk factors in older individuals, delivered through a mentor- supported interactive internet platform, can reduce the risk of cognitive decline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

April 14, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

March 14, 2019

Last Update Submit

July 14, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • cognition

    Mini-Mental State Examination

    5 minutes

  • cognition

    Montreal Cognitive Assessment

    10 minutes

  • objective parameters

    systolic blood pressure

    2 minutes

  • low-density-lipoprotein

    low-density-lipoprotein

    1 minutes

  • fasting blood sugar

    fasting blood sugar

    1 minutes

  • body mass index

    body mass index

    1 minutes

  • waist-hip ratio

    waist-hip ratio

    1 minutes

Secondary Outcomes (6)

  • physical activity scale for the elderly

    5 minutes

  • Senior fitness test

    15 minutes

  • Mediterranean Diet Adherence Screener

    5 minutes

  • Geriatric Depression Scale-15

    5 minutes

  • University of California, Los Angeles, Loneliness Scale

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

comparison group

NO INTERVENTION

The CG received no extra care.

Intervention Group

EXPERIMENTAL

Intervention Group, goal-setting with follow-up, will have a structured goalsetting interview using the Bangor Goal-Setting Interview ; once goals are identified and clearly expressed in accordance with SMART principles (specific, measureable, achievable, realistic, and timed)

Other: goal-setting

Interventions

The interviewer will have access to key information from the initial assessment such as details of identified risks. Areas where the participant would like to make changes or improvements will be identified and prioritized, and up to five specific, realistic and achievable goals will be identified.

Intervention Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in Northern Taiwan
  • at least one of the 8 modifiable risk factors for dementia (Hearing loss, Hypertension, Obesity, Smoking, Depression, Physical inactivity, Social isolation, and Diabetes)
  • living independently
  • in the local community

You may not qualify if:

  • can't speak chinese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Organizational Objectives

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, School of Nursing

Study Record Dates

First Submitted

March 14, 2019

First Posted

April 2, 2019

Study Start

April 14, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations