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

NCT ID: NCT05860127

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2025-06-30

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.

Conditions

Dementia; Cognitive Impairment, Mild; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Frontal; Dementia Moderate; Dementia of Alzheimer Type; Dementia, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Referral for Cognitive Stimulation Therapy

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

Group Type: ACTIVE_COMPARATOR

Referral for Cognitive Stimulation Therapy

Intervention Type: BEHAVIORAL

Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement

Standard of Care

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

Group Type: PLACEBO_COMPARATOR

No change to Standard of Care

Intervention Type: OTHER

Participants will not receive referral from a physician. They will continue with standard of care at their site.

Interventions

Referral for Cognitive Stimulation Therapy

Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement

Intervention Type: BEHAVIORAL

No change to Standard of Care

Participants will not receive referral from a physician. They will continue with standard of care at their site.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: lead

Responsible Party

Michael Lepore

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Lepore, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

UConn Center on Aging

Farmington, Connecticut, United States

Yale Memory Clinic

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

5U54AG063546-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00054748

Identifier Type: -

Identifier Source: org_study_id