Clinical trial NCT05860127: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Cognitive Impairment, Mild
Dementia, Vascular
Dementia, Mixed
Dementia With Lewy Bodies
Dementia Frontal
Dementia Moderate
Dementia of Alzheimer Type
Dementia, Mild
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: Yale University
name: UConn Health
name: National Institute on Aging (NIA)
name: University of Maryland, Baltimore
First posted: 2023-05-16
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Cognitive decline measured by an increase in Montreal Cognitive Assessment Score from baseline to follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive improvement measured by a decrease in Montreal Cognitive Assessment Score from baseline to follow-up
timeFrame: 6 months
measure: Referral Acceptance Rate
timeFrame: 1 month
measure: Participant attendance
timeFrame: 7 weeks
measure: Participant Attrition
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Center on Aging
state: Connecticut
city: New Haven
country: United States
facility: Yale Memory Clinic
state: Connecticut
Study officials:
affiliation: University of Massachusetts, Amherst
name: Michael Lepore, PhD
role: PRINCIPAL_INVESTIGATOR
References: