I-COACH: Improving Cognition of Older Adults in Community Housing

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05932342
Collaborator
LOFT Community Services (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Integrated program of cognitive remediation, physical exercise and socially stimulating activity
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The intervention will be provided over 3 iterative group of 6 participants eachThe intervention will be provided over 3 iterative group of 6 participants each
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Improving Cognition of Older Adults in Community Housing (I-COACH)
Anticipated Study Start Date :
Jun 26, 2023
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Integrated program of cognitive remediation, physical exercise and socially- stimulating activity

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

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

Outcome Measures

Primary Outcome Measures

  1. Participants' satisfaction [end of week 12 of the intervention]

    Measured using a 7-point Likert Scale survey

  2. Acceptability and Usability of Cognitive Remediation [end of week 12 of the intervention]

    Assessed Using the System Usability Scale

  3. Participants' feedback of the program [end of week 12 of the intervention]

    Semi-structured qualitative interview

  4. Staff Feedback of the program [Within one week from the end of week 12 of the intervention]

    Semi-structured qualitative interview

  5. Sessions and overall program attendance [end of week 12 of the intervention]

    Attendance logs

Secondary Outcome Measures

  1. Staff Feedback of the delivery of the program [Within one week from the end of week 12 of the intervention]

    Semi-structured qualitative interview

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Addiction and Mental Health Toronto Ontario Canada M6J 1H4

Sponsors and Collaborators

  • Centre for Addiction and Mental Health
  • LOFT Community Services

Investigators

  • Principal Investigator: Angela Golas, MD, Center for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT05932342
Other Study ID Numbers:
  • 027 - 2023
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre for Addiction and Mental Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2023