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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54AG063546-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Yale University | OTHER |
| UConn Health | OTHER |
| National Institute on Aging (NIA) | NIH |
| University of Maryland, Baltimore |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referral for Cognitive Stimulation Therapy | Active Comparator | This group will receive a referral from their physician for CST treatment |
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| Standard of Care | Placebo Comparator | This group will receive standard of care and no CST referral. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Referral for Cognitive Stimulation Therapy | Behavioral | Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Decrease and With no Increase in Psychotropic Medications | For each participant, we determined whether there was a decrease in psychotropic medications and no increase in psychotropic medications (i.e., favorable psychotropic medication outcomes), and then calculated the proportion of participants with favorable psychotropic medication outcomes across arms | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lepore, PhD | University of Massachusetts, Amherst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Center on Aging | Farmington | Connecticut | 06030 | United States | ||
| Yale Memory Clinic |
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133 participants were randomly assigned to the intervention or control group. Participants were enrolled at the time of randomization.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Referral for Cognitive Stimulation Therapy | This group will receive a referral from their physician for CST treatment |
| FG001 | Standard of Care | This group will receive standard of care and no CST referral. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2023 |
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| OTHER |
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| No change to Standard of Care | Other | Participants will not receive referral from a physician. They will continue with standard of care at their site. |
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| 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. | 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. | 7 weeks |
| New Haven |
| Connecticut |
| 06536 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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This protocol utilized a randomization stratified by site by a random number sequence in a 1:2 ratio.
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| ID | Title | Description |
|---|---|---|
| BG000 | Referral for Cognitive Stimulation Therapy | This group will receive a referral from their physician for CST treatment |
| BG001 | Standard of Care | This group will receive standard of care and no CST referral. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Sex of Participant | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/Ethnicity | Count of Participants | Participants |
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| Pre-assessment MoCA | This measurement is the Montreal Cognitive Assessment score which is a scale out of 30 points, with a minimum score of 0 and maximum score of 30. Scores 26 or higher are generally considered normal, scores 18-25 indicate mild cognitive impairment, 10-17 suggest moderate impairment, and below 10 signifies severe impairment. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Age, Continuous | Age in years | 1 unknown age for the control group | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were randomized to intervention or standard of care group. | Posted | Mean | 95% Confidence Interval | Score on a scale | 12 months |
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| Other Pre-specified | Percentage of Participants With a Decrease and With no Increase in Psychotropic Medications | For each participant, we determined whether there was a decrease in psychotropic medications and no increase in psychotropic medications (i.e., favorable psychotropic medication outcomes), and then calculated the proportion of participants with favorable psychotropic medication outcomes across arms | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 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. | Participants were evaluated based on acceptance of referral | Posted | Count of Participants | Participants | 1 month |
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| Secondary | 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. | Participants evaluated based on participant attendance in CST | Posted | Count of Participants | Participants | 7 weeks |
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| Secondary | 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. | Of the 42 individuals referred for V-CST, 16 (38.1%) accepted the referral and were approved by the CBO for V-CST participation. Of these 16 individuals, nine (56.3%) completed V-CST and seven (43.7%) were lost to attrition before completing V-CST. | Posted | Number | participants | 7 weeks |
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Participants were reviewed for adverse events over a 12 month period
Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Referral for Cognitive Stimulation Therapy | This group will receive a referral from their physician for CST treatment | 3 | 50 | 6 | 50 | 3 | 50 |
| EG001 | Standard of Care | This group will receive standard of care and no CST referral. | 3 | 83 | 9 | 83 | 13 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular Exacerbation | Cardiac disorders | Non-systematic Assessment |
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| Perinephric hematoma | Renal and urinary disorders | Non-systematic Assessment |
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| Failure to thrive | General disorders | Non-systematic Assessment |
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| Metabolic Encephalopathy | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Foot infection | Infections and infestations | Non-systematic Assessment |
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| Uncontrolled diabetes | Endocrine disorders | Non-systematic Assessment |
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| Altered Mental Status | Nervous system disorders | Non-systematic Assessment |
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| Febrile Illness/Sepsis | Infections and infestations | Non-systematic Assessment |
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| Respiratory illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Parkinson's disease | Nervous system disorders | Non-systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Trcyclic acid overdose | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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A shortcoming was a high rate of missing follow-up cognitive assessment data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Lepore | University of Massachusetts Amherst | 4135455093 | mjlepore@umass.edu |
| Jul 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D015140 | Dementia, Vascular |
| D000093902 | Mixed Dementias |
| D020961 | Lewy Body Disease |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Black or African American |
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| Asian |
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| Unknown |
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The equivalence margin is 3 points on the MoCA
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