DementiaV-iCSTNCT04828434
Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study
A study testing Virtual Individual Cognitive Simulation Therapy in people with Dementia and Dementia, Vascular, run by University College, London at 1 site in United Kingdom.
Trial summary
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Dementia, Mixed
- What is being tested?
- Virtual Individual Cognitive Simulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia, according to the DSM-IV
- MoCA - BLIND ≥ 2
- Age ≥ 18
- Ability to communicate in English
- Ability to complete outcome measures
- Capacity to consent
- Consent to video-conferencing
- Access to video-conferencing
Who cannot join
- 1) Illness and disability that affects participation (as deemed by researcher)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. The investigators seek to bridge the current treatment gap with a virtual and individual form of CST, called Virtual Individual Cognitive Stimulation Therapy (V-iCST). This psychosocial intervention was adapted from the key principles of CST and developed within the Medical Research Council (MRC) framework for complex interventions. The investigators aim to evaluate the feasibility and acceptability of V-iCST in a Randomized Controlled Trial.
This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.
Read the detailed description
Dementia, a global epidemic, affects 50 million individuals worldwide. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the UK government to improve cognition for mild to moderate dementia. It is delivered in over 85% of National Health Services (NHS) services and is offered in 34 countries. Unfortunately, this routine treatment is suspended due to lockdown, even though people with dementia are disproportionately affected by COVID-19. Accessible treatment is a pressing need. Virtual Individual Cognitive Stimulation Therapy (V-iCST) aims to bridge this treatment gap as an evidence-based treatment for dementia, developed within the Medical Research Council (MRC) Framework for complex interventions using principles of CST. There may still be a demand for V-iCST post-pandemic because those with sensory impairments and lack of transport provision may prefer a virtual and individual treatment. The investigators aim to 1) design V-iCST; 2) evaluate V-iCST in a feasibility Randomized Controlled Trial (RCT). A sample of 34 participants will be recruited. Seventeen will be allocated to V-iCST, and 17 to treatment as usual (TAU), the control group. Data will be collected pre-and post-test. Dementia prevalence is projected to reach 152 million worldwide by 2050. Therefore, accessible treatment is paramount during the pandemic and beyond.
- Conditions
- Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia, Mild
- Being tested
- Virtual Individual Cognitive Simulation Therapy
- Keywords
- Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions
- Medical subject headings
- Dementia, Dementia, Vascular, Mixed Dementias, Lewy Body Disease, Lymphoma, Follicular, Alzheimer Disease, Dementia, Multi-Infarct, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Individual Cognitive Simulation TherapyOther
Virtual Individual Cognitive Stimulation Therapy (V-iCST) is an individual and virtual adaptation of Cognitive Stimulation Therapy (CST), a routine psychosocial treatment for people with mild to moderate dementia in the UK.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Individual Cognitive Stimulation Therapy | Experimental | Virtual Cognitive Stimulation Therapy (V-iCST), a psychosocial intervention, is a modified version of CST for people with mild to moderate dementia. Like the original CST, each of the 14 sessions will begin with a "warm-up activity," which includes an orientation task and discussion of current affairs, followed by a main activity.
V-iCST will be prescribed to participants twice a week, for 7 weeks and each session is approx. 45 minutes. The intervention will be delivered by trained professionals, such as research staff, psychologists, and trainee clinical psychologists. All facilitators will have experience in dementia care and will have completed the CST training. Receives: Other: Virtual Individual Cognitive Simulation Therapy |
| Treatment as usual | No intervention | Standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment (feasibility of V-iCST)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Measured: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Retention rate (feasibility of V-iCST)
Retention rate of at least 75% of participants at 9-week follow-up.
Measured: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Attendance and retention rate (acceptability of V-iCST)
Overall attendance and retention rates among the participants (60%) at 9-week follow-up.
Measured: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Negative of adverse events (acceptability of V-iCST)
Any negative or adverse events related to the intervention
Measured: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Fidelity (acceptability of V-iCST)
Fidelity will also be assessed to ensure that facilitators adhered to the protocol. Fidelity will be evaluated by a) facilitators' completion of the fidelity checklist following each session; b) vide recordings of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
Measured: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Secondary outcomes (6)
Change in cognitive function
Exploratory outcome; measured pre-and post-intervention with Montreal Cognitive Assessment Blind Version (MoCA-BLIND) (Wittich et al., 2010). MoCA - BLIND is a short version of the Montreal Cognitive Assessment designed for the visually impaired. It consists of 6 items with scores from 0 to 22, where a low score indicates poor performance.
Measured: Pre-test (baseline: week 0) and post test (week 9)
Change in cognitive function
Exploratory outcome; measured pre-and post-intervention with Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (Rosen et al., 1984). ADAS-Cog is a sensitive scale measuring cognitive function with more items on short-term memory. This scale is frequently used in dementia drug trials, and has 11 items, and a total score of 70, where the higher the score, the more severe the impairments.
Measured: Pre-test (baseline: week 0) and post test (week 9)
Change in quality of life
Exploratory outcome; measured pre-and post-test with Quality of Life in Alzheimer's Disease (QoL-AD) (Logsdon et al., 2002). QoL-AD has 13-items, and a sum score range from 13 to 52; higher score denotes better quality of life.
Measured: Pre-test (baseline: week 0) and post test (week 9)
Change in mood
Exploratory outcome; measured pre-and post-test with Geriatric Depression Scale (GDS), a dichotomous screening tool with 15 items. Participants answer "yes" or "no" to symptoms of depression. A score of 10 or higher indicates depression.
Measured: Pre-test (baseline: week 0) and post test (week 9)
Change in communication
Exploratory outcome; measured pre-and post-test with Holden Communication Scale (Strom et al., 2016), a proxy-based instrument with 12 items developed to evaluate conversation, awareness, knowledge and communication. Each item contains five response options on a scale of 0 to 4, with a maximum score of 48. A higher score suggests difficulties with communication.
Measured: Pre-test (baseline: week 0) and post test (week 9)
Change in engagement
Exploratory outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney \& Rentz, 2005). An independent researcher will assess session recordings of every participant. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect.
Measured: Evaluated by an independent researcher through video recordings; up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Aimee Spector, PhD, DClinPsy, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828434
- Sponsor's protocol ID
- 17127/002/1
- Acronym
- V-iCST
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be published in peer-reviewed journals, doctoral theses and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion.
Publications
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PubMed 12021425Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PubMed 6496779Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.
PubMed 16136845Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
Yesavage JA, Sheikh JI. Geriatric Depression Scale (GDS) Recent evidence and development of shorter version. Clin Gerontol. 1986;5(1-2):165-73.
Wittich W, Phillips N, Nasreddine ZS, Chertkow H. Sensitivity and Specificity of the Montreal Cognitive Assessment Modified for Individuals who are Visually Impaired. Journal of Visual Impairment & Blindness. 2010;104(6):360-368.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04828434
- Acronym / sponsor ID
- V-iCST / 17127/002/1
- Conditions
- Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia, Mild
- Keywords
- Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Apr 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.
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. The investigators seek to bridge the current treatment gap with a virtual and individual form of CST, called Virtual Individual Cognitive Stimulation Therapy (V-iCST). This psychosocial intervention was adapted from the key principles of CST and developed within the Medical Research Council (MRC) framework for complex interventions. The investigators aim to evaluate the feasibility and acceptability of V-iCST in a Randomized Controlled Trial.
This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.
Detailed description
Dementia, a global epidemic, affects 50 million individuals worldwide. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the UK government to improve cognition for mild to moderate dementia. It is delivered in over 85% of National Health Services (NHS) services and is offered in 34 countries. Unfortunately, this routine treatment is suspended due to lockdown, even though people with dementia are disproportionately affected by COVID-19. Accessible treatment is a pressing need. Virtual Individual Cognitive Stimulation Therapy (V-iCST) aims to bridge this treatment gap as an evidence-based treatment for dementia, developed within the Medical Research Council (MRC) Framework for complex interventions using principles of CST. There may still be a demand for V-iCST post-pandemic because those with sensory impairments and lack of transport provision may prefer a virtual and individual treatment. The investigators aim to 1) design V-iCST; 2) evaluate V-iCST in a feasibility Randomized Controlled Trial (RCT). A sample of 34 participants will be recruited. Seventeen will be allocated to V-iCST, and 17 to treatment as usual (TAU), the control group. Data will be collected pre-and post-test. Dementia prevalence is projected to reach 152 million worldwide by 2050. Therefore, accessible treatment is paramount during the pandemic and beyond.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Individual Cognitive Stimulation Therapy | Experimental | Other: Virtual Individual Cognitive Simulation TherapyVirtual Cognitive Stimulation Therapy (V-iCST), a psychosocial intervention, is a modified version of CST for people with mild to moderate dementia. Like the original CST, each of the 14 sessions will begin with a "warm-up activity," which includes an orientation task and discussion of current affairs, followed by a main activity. V-iCST will be prescribed to participants twice a week, for 7 weeks and each session is approx. 45 minutes. The intervention will be delivered by trained professionals, such as research staff, psychologists, and trainee clinical psychologists. All facilitators will have experience in dementia care and will have completed the CST training. |
| Treatment as usual | No intervention | –Standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of dementia, according to the DSM-IV
- MoCA - BLIND ≥ 2
- Age ≥ 18
- Ability to communicate in English
- Ability to complete outcome measures
Key exclusion criteria (1 listed)
- 1) Illness and disability that affects participation (as deemed by researcher)
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 |
|---|---|---|
| Virtual Individual Cognitive Simulation TherapyVirtual Individual Cognitive Stimulation Therapy (V-iCST) is an individual and virtual adaptation of Cognitive Stimulation Therapy (CST), a routine psychosocial treatment for people with mild to moderate dementia in the UK. | Other | Virtual Individual Cognitive Stimulation Therapy |
Primary outcome
Recruitment (feasibility of V-iCST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Retention rate (feasibility of V-iCST)
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Retention rate of at least 75% of participants at 9-week follow-up.
Attendance and retention rate (acceptability of V-iCST)
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Overall attendance and retention rates among the participants (60%) at 9-week follow-up.
Negative of adverse events (acceptability of V-iCST)
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Any negative or adverse events related to the intervention
Fidelity (acceptability of V-iCST)
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Fidelity will also be assessed to ensure that facilitators adhered to the protocol. Fidelity will be evaluated by a) facilitators' completion of the fidelity checklist following each session; b) vide recordings of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
6 secondary outcomes
Change in cognitive function
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in cognitive function
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in quality of life
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in mood
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in communication
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in engagement
Time frame: Evaluated by an independent researcher through video recordings; up to 48 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Background: PubMed 12021425Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Background: PubMed 6496779Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
- Background: PubMed 16136845Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.
- BackgroundHolden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
- BackgroundYesavage JA, Sheikh JI. Geriatric Depression Scale (GDS) Recent evidence and development of shorter version. Clin Gerontol. 1986;5(1-2):165-73.
- BackgroundWittich W, Phillips N, Nasreddine ZS, Chertkow H. Sensitivity and Specificity of the Montreal Cognitive Assessment Modified for Individuals who are Visually Impaired. Journal of Visual Impairment & Blindness. 2010;104(6):360-368.
- Individual participant dataSharing planned: Yes. Study results will be published in peer-reviewed journals, doctoral theses and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion.
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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.
Aimee Spector, PhD, DClinPsy principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Individual Cognitive Simulation Therapy in people with Dementia and Dementia, Vascular, run by University College, London at 1 site in United Kingdom.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
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?
Recruitment (feasibility of V-iCST) (time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828434, which also lists 6 linked publications.
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 25 Mar 2022.