NCT05401747

Brief Summary

The CONCERT Study (A Comprehensive Online program for Cognitive Enhancement, Reassurance and Training) was designed to introduce a user-friendly platform to assess and train cognition among old adults. Our main research questions are: i) Is it possible to provide a user-friendly platform to perform multi-domain cognitive training for old adults? ii) Are there any safety issues with these platforms? Inclusion criteria include: i) Aged ≥ 65 years; ii) Owning a computer with access to the Internet and basic knowledge to use it; iii) Having sufficient English language skill; iv) Normal baseline AD8 screening test; v) agree to join the study with their partners/ close family members. Exclusion criteria include: i) History of dementia; ii) Severe physical disability precluding to participate in meetings; those using wheelchairs can still join the study with some modification in the exercise program. Study duration includes 24 weeks of intervention with lifestyle changes (Online: Nutrition consultation and teaching, Exercise, dance, music therapy and cognitive enhancement). Participants have options to continue the study for another 24 weeks. Outcome will be assessed based on participants' adherence, satisfaction.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Status
unknown

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

May 10, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

June 2, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

May 10, 2022

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of online classes for healthy lifestyle.

    To assess the adherence to online educational classes, each participant will receive a numeric code without any identifiers to join the meeting. The number of participants present in the meeting will be recorded to check for adherence. A booklet will be provided to the participants to note the programs used and their frequency during the week. The adherence to this study will be assessed using the trend test and Generalized Estimating Equation.

    24 weeks and 50 weeks (optional) after initiation of the study

Secondary Outcomes (1)

  • Satisfaction of online classes for healthy lifestyle.

    24 weeks and 50 weeks (optional) after initiation of the study

Study Arms (1)

Healthy lifestyle intervention

OTHER

All cases will be assessed before and after intervention for cognitive changes.

Other: Healthy lifestyle

Interventions

Nutrition consultation and teaching: A registered dietitian has the responsibility of teaching and explaining the diet. Plan: One meeting per 12 weeks. The exercise program is based on the Physical Activity Guidelines Advisory Committee and American Heart Association guideline and a modified version of Dose-Responses to Exercise Training study protocol for older adults summarized our weekly plans in detail. Plan: 2 meetings per week. Cognitive enhancement: Participants can select any of the following activities:methods requiring mental activities, physical activity, and social activity, enjoying music and our weekly dance classes (Waltz).

Healthy lifestyle intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged ≥ 65 years;
  • Owning a computer with access to the Internet and basic knowledge to use it;
  • Having sufficient English language skill;
  • Normal baseline AD8 screening test;

You may not qualify if:

  • History of dementia;
  • Severe physical disability precluding to participate in meetings; those using wheelchairs can still join the study with some modification in the exercise program;
  • Active coronary heart disease or limitation for exercise based on their previous consults with their family physician/ cardiologists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2022

First Posted

June 2, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

July 30, 2023

Last Updated

June 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Data can be shared only after the Ethics approval.