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Active, Not Recruiting

NCT Number: NCT05932342

Improving Cognition of Older Adults in Community Housing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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 outcomes

  1. Participant's satisfaction

    Time frame: end of week 12 of the intervention

    This is measured using the Satisfaction Survey which assesses participants' agreement on 10 statements each measuring the degree of agreement or disagreement of participants using a 7-point Likert Scale. Minimum score is 10 and maximum score is 70. Higher scores indicate better satisfaction.

  2. Acceptability and Usability of Cognitive Remediation

    Time frame: end of week 12 of the intervention

    This is assessed using the System Usability Scale (SUS). The scale is comprised of 10 statements each measuring the degree of agreement or disagreement of participants using 5 -point Likert Scale. Minimum score is 0 and maximum is 100. Higher scores indicate better usability.

  3. Participants' feedback of the program

    Time frame: end of week 12 of the intervention

    Semi-structured qualitative interview

  4. Staff Feedback of the program

    Time frame: Within one week from the end of week 12 of the intervention

    Semi-structured qualitative interview

  5. Sessions and overall program attendance

    Time frame: end of week 12 of the intervention

    Attendance logs

Secondary outcomes

  1. Staff Feedback of the delivery of the program

    Time frame: Within one week from the end of week 12 of the intervention

    Semi-structured qualitative interview

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • LOFT Community Services

Registry information

Official study title

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

Acronym: I-COACH

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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