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Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial

Primary Purpose

Dementia, Cognitive Impairment, Mild, Dementia, Vascular

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Referral for Cognitive Stimulation Therapy
No change to Standard of Care
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review English-speaking Visit scheduled to include cognitive screening 6 to 12 months after record review. Exclusion Criteria: Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment No access to online meeting platform Patient has specified to HCS not to engage patient in research or to use patient data in research Patient has previously participated in V-CST Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.

Sites / Locations

  • UConn Center on Aging
  • Yale Memory Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Referral for Cognitive Stimulation Therapy

Standard of Care

Arm Description

This group will receive a referral from their physician for CST treatment

This group will receive standard of care and no CST referral.

Outcomes

Primary Outcome Measures

Cognitive decline measured by an increase in Montreal Cognitive Assessment Score from baseline to follow-up
Clinically meaningful cognitive decline will be less common in intervention group than the control group. Clinically meaningful changes will be assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. An increase in the baseline MoCA score by 2 points or greater indicates a clinically meaningful decline in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.

Secondary Outcome Measures

Cognitive improvement measured by a decrease in Montreal Cognitive Assessment Score from baseline to follow-up
Clinically meaningful cognitive improvement will be more common in the intervention group than the control group. Clinically meaningful changes will be assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. A decrease in the baseline MoCA score by 2 points or greater indicates a clinically meaningful improvement in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.
Referral Acceptance Rate
V-CST referral will be favorably received by participants. V-CST referral will be assessed by referral acceptance rate measured by percentage of people referred for V-CST who accept the referral over the 1-month referral period process. This outcome will be assessed at the end of the referral process.
Participant attendance
V-CST treatment will be favorably received by participants. Participant attendance will be measured as the percentage of enrolled participants who attend each V-CST session. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.
Participant Attrition
V-CST treatment will be favorably received by participants. Participant attrition will be measured as the percentage of enrolled participants who cease attending V-CST between session 1 and session 14. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.

Full Information

First Posted
February 14, 2023
Last Updated
August 7, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Yale University, UConn Health, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05860127
Brief Title
Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
Official Title
Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Yale University, UConn Health, National Institute on Aging (NIA)

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
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia. The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE). The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment, Mild, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia Moderate, Dementia of Alzheimer Type, Dementia, Mild

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Referral for Cognitive Stimulation Therapy
Arm Type
Active Comparator
Arm Description
This group will receive a referral from their physician for CST treatment
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
This group will receive standard of care and no CST referral.
Intervention Type
Behavioral
Intervention Name(s)
Referral for Cognitive Stimulation Therapy
Intervention Description
Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement
Intervention Type
Other
Intervention Name(s)
No change to Standard of Care
Intervention Description
Participants will not receive referral from a physician. They will continue with standard of care at their site.
Primary Outcome Measure Information:
Title
Cognitive decline measured by an increase in Montreal Cognitive Assessment Score from baseline to follow-up
Description
Clinically meaningful cognitive decline will be less common in intervention group than the control group. Clinically meaningful changes will be assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. An increase in the baseline MoCA score by 2 points or greater indicates a clinically meaningful decline in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cognitive improvement measured by a decrease in Montreal Cognitive Assessment Score from baseline to follow-up
Description
Clinically meaningful cognitive improvement will be more common in the intervention group than the control group. Clinically meaningful changes will be assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. A decrease in the baseline MoCA score by 2 points or greater indicates a clinically meaningful improvement in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.
Time Frame
6 months
Title
Referral Acceptance Rate
Description
V-CST referral will be favorably received by participants. V-CST referral will be assessed by referral acceptance rate measured by percentage of people referred for V-CST who accept the referral over the 1-month referral period process. This outcome will be assessed at the end of the referral process.
Time Frame
1 month
Title
Participant attendance
Description
V-CST treatment will be favorably received by participants. Participant attendance will be measured as the percentage of enrolled participants who attend each V-CST session. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.
Time Frame
7 weeks
Title
Participant Attrition
Description
V-CST treatment will be favorably received by participants. Participant attrition will be measured as the percentage of enrolled participants who cease attending V-CST between session 1 and session 14. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review English-speaking Visit scheduled to include cognitive screening 6 to 12 months after record review. Exclusion Criteria: Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment No access to online meeting platform Patient has specified to HCS not to engage patient in research or to use patient data in research Patient has previously participated in V-CST Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lepore, PhD
Organizational Affiliation
University of Maryland Baltimore School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Center on Aging
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Yale Memory Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial

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