Back to resultsImplementation of Cognitive Stimulation Therapy
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Stimulation Therapy
Sponsored by
About this trial
This is an interventional other trial for Dementia
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
Sites / Locations
- Durham Center for Senior Life
- Program for All Inclusive Care of the Elderly
- The Forest at Duke
- Program for All Inclusive Care of the Elderly
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Community Site 1
Community Site 2
Community Site 3
Community Site 4
Community Site 5
Arm Description
CST Implementation community site
CST Implementation community site
CST Implementation community site
CST Implementation community site
CST Implementation community site
Outcomes
Primary Outcome Measures
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
Change in cognitive status as measured by Saint Louis University Mental Status Examination
A validated 30 point office-based cognitive screen
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.
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
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Adoption as measured by the percentage of non-participating centers to the total number approached.
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
Maintenance as measured by percentage of long-term attrition
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04754932
Brief Title
Implementation of Cognitive Stimulation Therapy
Official Title
Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community Site 1
Arm Type
Experimental
Arm Description
CST Implementation community site
Arm Title
Community Site 2
Arm Type
Experimental
Arm Description
CST Implementation community site
Arm Title
Community Site 3
Arm Type
Experimental
Arm Description
CST Implementation community site
Arm Title
Community Site 4
Arm Type
Experimental
Arm Description
CST Implementation community site
Arm Title
Community Site 5
Arm Type
Experimental
Arm Description
CST Implementation community site
Intervention Type
Other
Intervention Name(s)
Cognitive Stimulation Therapy
Intervention Description
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Primary Outcome Measure Information:
Title
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
Time Frame
2 years
Title
Change in cognitive status as measured by Saint Louis University Mental Status Examination
Description
A validated 30 point office-based cognitive screen
Time Frame
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Title
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia
Description
A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Time Frame
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Title
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)
Description
A 5-point scale measuring general well-being/quality of life for older adults
Time Frame
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Title
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
Description
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Time Frame
Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Title
Adoption as measured by the percentage of non-participating centers to the total number approached.
Time Frame
2 years
Title
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
Time Frame
1 year
Title
Maintenance as measured by percentage of long-term attrition
Time Frame
2 years
Title
Assess the barriers and facilitators to implementation of CST in community settings
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milta Little, DO
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Center for Senior Life
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Program for All Inclusive Care of the Elderly
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
The Forest at Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Program for All Inclusive Care of the Elderly
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Implementation of Cognitive Stimulation Therapy
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