DementiaNCT04754932
Implementation of Cognitive Stimulation Therapy
A study testing Cognitive Stimulation Therapy in people with Dementia, run by Duke University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Cognitive Stimulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Durham Center for Senior Life
Durham, North Carolina, 27701
Program for All Inclusive Care of the Elderly
Durham, North Carolina, 27703
The Forest at Duke
Durham, North Carolina, 27705
Program for All Inclusive Care of the Elderly
Greensboro, North Carolina, 27405
About this study
Official title: Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
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.
- Conditions
- Dementia
- Being tested
- Cognitive Stimulation Therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation TherapyOther
Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Community Site 1 | Experimental | CST Implementation community site Receives: Other: Cognitive Stimulation Therapy |
| Community Site 2 | Experimental | CST Implementation community site Receives: Other: Cognitive Stimulation Therapy |
| Community Site 3 | Experimental | CST Implementation community site Receives: Other: Cognitive Stimulation Therapy |
| Community Site 4 | Experimental | CST Implementation community site Receives: Other: Cognitive Stimulation Therapy |
| Community Site 5 | Experimental | CST Implementation community site Receives: Other: Cognitive Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
Measured: 2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination
A validated 30 point office-based cognitive screen
Measured: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
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.
Measured: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
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
Measured: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Measured: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Adoption as measured by the percentage of non-participating centers to the total number approached.
Measured: 2 years
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
Measured: 1 year
Maintenance as measured by percentage of long-term attrition
Measured: 2 years
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start27 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milta Little, DO, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754932
- Sponsor's protocol ID
- Pro00106751
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
- ClinicalTrials.gov ID
- NCT04754932
- Acronym / sponsor ID
- Pro00106751
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Community Site 1 | Experimental | Other: Cognitive Stimulation TherapyCST Implementation community site |
| Community Site 2 | Experimental | Other: Cognitive Stimulation TherapyCST Implementation community site |
| Community Site 3 | Experimental | Other: Cognitive Stimulation TherapyCST Implementation community site |
| Community Site 4 | Experimental | Other: Cognitive Stimulation TherapyCST Implementation community site |
| Community Site 5 | Experimental | Other: Cognitive Stimulation TherapyCST Implementation community site |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Stimulation TherapyGroup-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators. | Other | Community Site 1, Community Site 2, Community Site 3, Community Site 4, Community Site 5 |
Primary outcome
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
Time frame: 2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination
Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 30 point office-based cognitive screen
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia
Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A 5-point scale measuring general well-being/quality of life for older adults
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Adoption as measured by the percentage of non-participating centers to the total number approached.
Time frame: 2 years
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
Time frame: 1 year
Maintenance as measured by percentage of long-term attrition
Time frame: 2 years
Assess the barriers and facilitators to implementation of CST in community settings
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milta Little, DO principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation Therapy in people with Dementia, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.