Brief Summary

This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2021

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

February 5, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed

Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

February 5, 2021

Last Update Submit

April 12, 2023

Conditions

Dementia

Outcome Measures

Primary Outcomes (9)

Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination
A validated 30 point office-based cognitive screen
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia
A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)
A 5-point scale measuring general well-being/quality of life for older adults
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Adoption as measured by the percentage of non-participating centers to the total number approached.
2 years
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
1 year
Maintenance as measured by percentage of long-term attrition
2 years
Assess the barriers and facilitators to implementation of CST in community settings
Focus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention. Implementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.
1 year