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Implementation of Cognitive Stimulation Therapy

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ClinicalTrials.gov Identifier: NCT04754932
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Other: Cognitive Stimulation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : July 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Community Site 1
CST Implementation community site
 Other: Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 2
CST Implementation community site
 Other: Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 3
CST Implementation community site
 Other: Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 4
CST Implementation community site
 Other: Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 5
CST Implementation community site
 Other: Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.


Outcome Measures
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Primary Outcome Measures :
  1. Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation [ Time Frame: 2 years ]
  2. 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

  3. 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.

  4. 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

  5. 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

  6. Adoption as measured by the percentage of non-participating centers to the total number approached. [ Time Frame: 2 years ]
  7. Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist. [ Time Frame: 1 year ]
  8. Maintenance as measured by percentage of long-term attrition [ Time Frame: 2 years ]
  9. 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.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754932


Contacts
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Contact: Milta Little, DO 919-660-7584 milta.little@duke.edu

Locations
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United States, North Carolina
Durham Center for Senior Life Recruiting
Durham, North Carolina, United States, 27701
Contact: Melissa Black         
Program for All Inclusive Care of the Elderly Recruiting
Durham, North Carolina, United States, 27703
Contact: Antionette Hively         
The Forest at Duke Recruiting
Durham, North Carolina, United States, 27705
Contact: Lee Ann Bailey-Clayton         
Program for All Inclusive Care of the Elderly Recruiting
Greensboro, North Carolina, United States, 27405
Contact: Brianne Martindale         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Milta Little, DO Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04754932    
Other Study ID Numbers: Pro00106751
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders