Clinical trial NCT04754932: Implementation of Cognitive Stimulation Therapy
Official title: Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.


Eligibility criteria: Inclusion Criteria:

* established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL
* has a SLUMS score greater than 10.

Exclusion Criteria:

* unable to hold a meaningful conversation,
* unable to hear well enough to participate in a small group discussion
* severe visual impairment that precludes ability to see most pictures
* unable to remain in a group setting for 45 minutes

Primary outcomes:
measure: Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
timeFrame: 2 years
measure: Change in cognitive status as measured by Saint Louis University Mental Status Examination
timeFrame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
measure: Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia
timeFrame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
measure: Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)
timeFrame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
measure: Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
timeFrame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
measure: Adoption as measured by the percentage of non-participating centers to the total number approached.
timeFrame: 2 years
measure: Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
timeFrame: 1 year
measure: Maintenance as measured by percentage of long-term attrition
timeFrame: 2 years
measure: Assess the barriers and facilitators to implementation of CST in community settings
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Center for Senior Life
state: North Carolina
city: Durham
country: United States
facility: Program for All Inclusive Care of the Elderly
state: North Carolina
city: Durham
country: United States
facility: The Forest at Duke
state: North Carolina
city: Greensboro
country: United States
facility: Program for All Inclusive Care of the Elderly
state: North Carolina
Study officials:
affiliation: Duke University
name: Milta Little, DO
role: PRINCIPAL_INVESTIGATOR
References: