Clinical trial NCT05932342: Improving Cognition of Older Adults in Community Housing
Official title: Improving Cognition of Older Adults in Community Housing (I-COACH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Mental Disorder
Keywords: cognitive remediation
social activity
exercise
aging
community
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: LOFT Community Services
First posted: 2023-07-06
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention will be provided over 3 iterative group of 6 participants each
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Any race or ethnicity
3. Any gender identity
4. Meets DSM-V criteria for any disorder
5. 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.
6. Willingness and ability to speak English
7. Willingness to provide informed consent or assent as applicable.
8. 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:

1. Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
2. Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.

Primary outcomes:
measure: Participant's satisfaction
timeFrame: end of week 12 of the intervention
measure: Acceptability and Usability of Cognitive Remediation
timeFrame: end of week 12 of the intervention
measure: Participants' feedback of the program
timeFrame: end of week 12 of the intervention
measure: Staff Feedback of the program
timeFrame: Within one week from the end of week 12 of the intervention
measure: Sessions and overall program attendance
timeFrame: end of week 12 of the intervention
Secondary outcomes:
measure: Staff Feedback of the delivery of the program
timeFrame: Within one week from the end of week 12 of the intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Center for Addiction and Mental Health
name: Angela Golas, MD
role: PRINCIPAL_INVESTIGATOR
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