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

University of Massachusetts, Amherst133 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

133

Conditions

Dementia Cognitive Impairment, Mild

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cognitive Impairment

Cognitive Impairment was 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' was used to convert all cognitive assessment measures to a MoCA score. MoCA scores range from 0-30, with 26+ generally considered normal, while scores below that suggest cognitive issues: 18-25 is often mild impairment, 10-17 is moderate, and under 10 is severe impairment. All participants started with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment.

Time frame: 12 months

Secondary Outcomes

Percentage of Participants Who Accepted the Referral

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 from their physician over the 1-month referral period process. This outcome will be assessed at the end of the referral process. The referral process is defined by the physician offering the referral to participants, the acceptance of the referral then leads to the physician sending the referral to the CBO to follow up.

Time frame: 1 month

Percentage of Participants Who Completed Cognitive Stimulation Therapy

Participant completion will be measured as the percentage of enrolled participants who attend V-CST as a completer. A participant is considered a V-CST completer if they attend at least 8 or more of V-CST sessions. This outcome will be assessed at the end of the final V-CST session. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST.

Time frame: 7 weeks

Percentage of Participants Who Did Not Complete CST

V-CST treatment will be favorably received by participants. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST, with 16 participants agreeing to participate and enrolled in V-CST. 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.