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
About this trial
This is an interventional health services research trial for Cognition Disorders in Old Age
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.
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
NCT ID
NCT05401747
First Posted
May 10, 2022
Last Updated
May 30, 2022
Sponsor
Lawson Health Research Institute
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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