Cognitive Impairment, Mild, Dementia, Dementia Frontal, Dementia, Mild, Dementia, Mixed, Dementia Moderate, Dementia of Alzheimer Type, Dementia, Vascular, Dementia With Lewy Bodies
Conditions
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.
Interventions
BEHAVIORALReferral for Cognitive Stimulation Therapy
Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement
OTHERNo change to Standard of Care
Participants will not receive referral from a physician. They will continue with standard of care at their site.
Sponsors
University of Massachusetts, Amherst
Yale University
UConn Health
National Institute on Aging (NIA)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Impairment | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Accepted the Referral | 1 month | 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. |
| Percentage of Participants Who Completed Cognitive Stimulation Therapy | 7 weeks | 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. |
| Percentage of Participants Who Did Not Complete CST | 7 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Lepore, PhD
University of Massachusetts, Amherst
Participant flow
Recruitment details
Subject participants were identified from patient panels of two physicians in two health care systems (HCSs), one at UConn Health and one at Yale. From review of EHR records at both sites, a total of 224 eligible patients were identified. Target enrollment was 168 participants. Physicians screened out 87 participants from the trial. After patient screening by physicians, a total of 133 participants were enrolled: 94 from the Yale site and 39 from UConn Health.
Pre-assignment details
133 participants were randomly assigned to the intervention or control group. Participants were enrolled at the time of randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 12.46 |
| Pre-assessment MoCA | 19.76 scores on a scale STANDARD_DEVIATION 3.84 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 119 Participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 50 | 3 / 83 |
| other Total, other adverse events | 3 / 50 | 13 / 83 |
| serious Total, serious adverse events | 6 / 50 | 9 / 83 |
Outcome results
None listed