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A Comprehensive ONline Program for Cognitive Enhancement, Reassurance and Training

Primary Purpose

Cognition Disorders in Old Age, Lifestyle, Healthy, Diet, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy lifestyle
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognition Disorders in Old Age

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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;
  • Agree to join the study with their partners/ close family members. Age of family member or friend is not an exclusion criteria.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Healthy lifestyle intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Satisfaction of online classes for healthy lifestyle.
    The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) will be used to evaluate participants' satisfaction. Patient's interest to participate in the second phase of the study (optional) and willingness to introduce the study to friends/ family members will be used as markers of total satisfaction.

    Full Information

    First Posted
    May 10, 2022
    Last Updated
    May 30, 2022
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05401747
    Brief Title
    A Comprehensive ONline Program for Cognitive Enhancement, Reassurance and Training
    Official Title
    CONCERT STUDY: A Comprehensive ONline Program for Cognitive Enhancement, Reassurance and Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    July 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The CONCERT study is designed to provide an online platform for the public to provide healthy lifestyle recommendations and assess cognition. 60 participants (30 cases and 30 study partners) will be invited to this project. At baseline, all cases will be assessed with regard to cognition (AD8 Dementia Screening Interview), depression (Geriatric Depression Scale) and gait (Timed Up and Go). Participants will be asked to check their blood pressure at baseline and then every 3 months according to the Hypertension Canada's 2020 Guideline. All cases will be asked to participate in different educational classes, including nutrition consultation and teaching, exercise, dance (waltz), and music for 24 weeks. They will be also advised to accept the responsibility of a plant (Pothos, Spider Plant, Crocodile Fern and Aglaonema) at home. All meetings/ assessments are online. The investigators will assess adherence and satisfaction in all cases after 24 weeks. All cases will be invited to participate in another 24 weeks of intervention as an optional part of this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognition Disorders in Old Age, Lifestyle, Healthy, Diet, Healthy, Exercise

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy lifestyle intervention
    Arm Type
    Other
    Arm Description
    All cases will be assessed before and after intervention for cognitive changes.
    Intervention Type
    Other
    Intervention Name(s)
    Healthy lifestyle
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Feasibility of online classes for healthy lifestyle.
    Description
    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.
    Time Frame
    24 weeks and 50 weeks (optional) after initiation of the study
    Secondary Outcome Measure Information:
    Title
    Satisfaction of online classes for healthy lifestyle.
    Description
    The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) will be used to evaluate participants' satisfaction. Patient's interest to participate in the second phase of the study (optional) and willingness to introduce the study to friends/ family members will be used as markers of total satisfaction.
    Time Frame
    24 weeks and 50 weeks (optional) after initiation of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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; Agree to join the study with their partners/ close family members. Age of family member or friend is not an exclusion criteria. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tisha Mab
    Phone
    5199315731
    Email
    tisha@robarts.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data can be shared only after the Ethics approval.

    Learn more about this trial

    A Comprehensive ONline Program for Cognitive Enhancement, Reassurance and Training

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