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Improving Cognition of Older Adults in Community Housing (I-COACH)

Primary Purpose

Aging, Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Integrated program of cognitive remediation, physical exercise and socially stimulating activity
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging focused on measuring cognitive remediation, social activity, exercise, aging, community

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness Any race or ethnicity Any gender identity Meets DSM-V criteria for any disorder Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists. Willingness and ability to speak English Willingness to provide informed consent or assent as applicable. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Both vision and hearing ability will be assessed by asking the participant if they can see the text and hear the research personnel during the screening consent and enrolment process. Exclusion Criteria: Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.

Sites / Locations

  • Center for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated program of cognitive remediation, physical exercise and socially- stimulating activity

Arm Description

Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week

Outcomes

Primary Outcome Measures

Participants' satisfaction
Measured using a 7-point Likert Scale survey
Acceptability and Usability of Cognitive Remediation
Assessed Using the System Usability Scale
Participants' feedback of the program
Semi-structured qualitative interview
Staff Feedback of the program
Semi-structured qualitative interview
Sessions and overall program attendance
Attendance logs

Secondary Outcome Measures

Staff Feedback of the delivery of the program
Semi-structured qualitative interview

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
LOFT Community Services
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1. Study Identification

Unique Protocol Identification Number
NCT05932342
Brief Title
Improving Cognition of Older Adults in Community Housing
Acronym
I-COACH
Official Title
Improving Cognition of Older Adults in Community Housing (I-COACH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Anticipated)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
LOFT Community Services

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 I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience. We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.
Detailed Description
This project entails the development and implementation of a12-week integrated program of cognitive remediation (CR) in combination with social and physical activity of 18 older adults living in senior housing. The study will be recruiting individuals, age 50 or older, who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnosis and are living in community housing. Participants will be recruited from five senior housing units. Prior to enrollment, participants will undergo a baseline assessment consistent of neuropsychological assessment (NP). Once enrolled, each participant will participate in the 12 - weeks program. The program will be offered 4 days per week and will consist of 2 days of 1-hour CR training, one day of 30 min physical activity and one day of 1-hour social activity. The intervention will be delivered by the research team and the senior community housing PSWs. The PSWs involved in the study are part of the participant's circle of care and will be trained and operating under supervision in collaboration with the research team. Following the completion of the 12-week program, group participants and staff will be invited to complete a satisfaction survey and the System Usability Scale (SUS) to gauge their feedback to the program and also to complete a semi-structured interview involving a qualitative assessment. Primary Aim: To design a feasible and tolerable active program for seniors living in the community setting. Secondary Aim: To modify CR using an iterative process that meets the capacity of senior community housing PSWs to deliver CR independently.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mental Disorder
Keywords
cognitive remediation, social activity, exercise, aging, community

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The intervention will be provided over 3 iterative group of 6 participants each
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated program of cognitive remediation, physical exercise and socially- stimulating activity
Arm Type
Experimental
Arm Description
Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week
Intervention Type
Behavioral
Intervention Name(s)
Integrated program of cognitive remediation, physical exercise and socially stimulating activity
Intervention Description
Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport.
Primary Outcome Measure Information:
Title
Participants' satisfaction
Description
Measured using a 7-point Likert Scale survey
Time Frame
end of week 12 of the intervention
Title
Acceptability and Usability of Cognitive Remediation
Description
Assessed Using the System Usability Scale
Time Frame
end of week 12 of the intervention
Title
Participants' feedback of the program
Description
Semi-structured qualitative interview
Time Frame
end of week 12 of the intervention
Title
Staff Feedback of the program
Description
Semi-structured qualitative interview
Time Frame
Within one week from the end of week 12 of the intervention
Title
Sessions and overall program attendance
Description
Attendance logs
Time Frame
end of week 12 of the intervention
Secondary Outcome Measure Information:
Title
Staff Feedback of the delivery of the program
Description
Semi-structured qualitative interview
Time Frame
Within one week from the end of week 12 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness Any race or ethnicity Any gender identity Meets DSM-V criteria for any disorder Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists. Willingness and ability to speak English Willingness to provide informed consent or assent as applicable. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Both vision and hearing ability will be assessed by asking the participant if they can see the text and hear the research personnel during the screening consent and enrolment process. Exclusion Criteria: Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Golas, MD
Phone
4165358501
Ext
30400
Email
Angela.Golas@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dewi Clark, MHSc
Phone
4165358501
Ext
30409
Email
dewi.clark@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Golas, MD
Organizational Affiliation
Center for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Golas, MD
Phone
4165358501
Email
Angela.Golas@camh.ca
First Name & Middle Initial & Last Name & Degree
Dewi Clark, MHSc
Phone
4165358501
Ext
30409
Email
dewi.clark@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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16977681
Citation
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Improving Cognition of Older Adults in Community Housing

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