Implementation of Cognitive Stimulation Therapy

Dementia Clinical Trial

Official title:

Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754932
• Other study ID #: Pro00106751
• Status: Completed
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Cognitive Stimulation Therapy
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.

Locations

Country	Name	City	State
United States	Durham Center for Senior Life	Durham	North Carolina
United States	Program for All Inclusive Care of the Elderly	Durham	North Carolina
United States	The Forest at Duke	Durham	North Carolina
United States	Program for All Inclusive Care of the Elderly	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation		2 years
Primary	Change in cognitive status as measured by Saint Louis University Mental Status Examination	A validated 30 point office-based cognitive screen	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Primary	Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia	A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Primary	Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)	A 5-point scale measuring general well-being/quality of life for older adults	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Primary	Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory	A validated 12-domain questionnaire to assess dementia-related behavioral symptoms	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Primary	Adoption as measured by the percentage of non-participating centers to the total number approached.		2 years
Primary	Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.		1 year
Primary	Maintenance as measured by percentage of long-term attrition		2 years
Primary	Assess the barriers and facilitators to implementation of CST in community settings	Focus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention.; Implementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.	1 year