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Clinical Trials/NCT04754932
NCT04754932
Completed
N/A

Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses

Duke University3 sites in 1 country23 target enrollmentMay 27, 2021
ConditionsDementia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dementia
Sponsor
Duke University
Enrollment
23
Locations
3
Primary Endpoint
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2021
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation

Time Frame: 2 years

Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)

Time Frame: 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

Time Frame: 2 years

Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Time Frame: 2 years

Change in cognitive status as measured by Saint Louis University Mental Status Examination

Time Frame: 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.

Time Frame: 1 year

Study Sites (3)

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