Implementation of Cognitive Stimulation Therapy

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Cognitive Stimulation Therapy

• Registration Number: NCT04754932
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Study Start: 2021-05-27
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL
• has a SLUMS score greater than 10.

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Exclusion Criteria

• unable to hold a meaningful conversation,
• unable to hear well enough to participate in a small group discussion
• severe visual impairment that precludes ability to see most pictures
• unable to remain in a group setting for 45 minutes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Site 3	Cognitive Stimulation Therapy	CST Implementation community site
Community Site 2	Cognitive Stimulation Therapy	CST Implementation community site
Community Site 5	Cognitive Stimulation Therapy	CST Implementation community site
Community Site 1	Cognitive Stimulation Therapy	CST Implementation community site
Community Site 4	Cognitive Stimulation Therapy	CST Implementation community site

Primary Outcome Measures

Name	Time	Method
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation	2 years
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month	A 5-point scale measuring general well-being/quality of life for older adults
Maintenance as measured by percentage of long-term attrition	2 years
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month	A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month	A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Assess the barriers and facilitators to implementation of CST in community settings	1 year	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.
Adoption as measured by the percentage of non-participating centers to the total number approached.	2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month	A validated 30 point office-based cognitive screen
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.	1 year

Trial Locations

Locations (3)

Durham Center for Senior Life; 🇺🇸 Durham, North Carolina, United States

Program for All Inclusive Care of the Elderly; 🇺🇸 Greensboro, North Carolina, United States

The Forest at Duke; 🇺🇸 Durham, North Carolina, United States