DementiaNCT04695743
Group CST Using Zoom: A Proof of Concept Study
A study testing Online Cognitive Stimulation Therapy in people with Dementia, run by University College, London at 1 site in United Kingdom.
Trial summary
People living with dementia (PLWD) often struggle to access services and treatment which may benefit their emotional and cognitive wellbeing, as well as disease progression. Transport provision; hospital access and restricted mobility are barriers that often deny people the opportunity to receive treatment in-line… 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?
- Online Cognitive Stimulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 1 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
- Must have a clinical diagnosis of dementia and be within the 'mild-moderate' stages of disease progression.
- Must be able to communicate verbally in English.
- Must have capacity to consent to complete measures and to consent to video recording of the individual sessions.
- Must have access to a device capable of video-conferencing and internet at home.
- Must not be accessing any other psychosocial intervention (I.e. psychological therapy) at the time of participation
Who cannot join
- Not having a clinical diagnosis of dementia or being within the 'moderate- sever' stages of disease progression
- Not being able to communicate verbally in English
- Not have the capacity to take consent to participation
- Not have access to a device capable of video-conferencing and internet at home.
- If the person is accessing any other psychosocial intervention (I.e. psychological therapy) at the time of participation
Trial locations and contacts
1 site in 1 country.
Luke Perkins contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London, WC1E 6BT
Aimee Spector, 020 7679 1844 ext. 41844, a.spector@ucl.ac.uk
Luke Perkins
About this study
Official title: Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
People living with dementia (PLWD) often struggle to access services and treatment which may benefit their emotional and cognitive wellbeing, as well as disease progression. Transport provision; hospital access and restricted mobility are barriers that often deny people the opportunity to receive treatment in-line with NICE guidelines. Considering the current Covid-19 pandemic, hospital access and face-to-face treatment is even more limited at present; with services across the UK unable to offer their usual levels of care and support. This is particularly the case for people in vulnerable groups. Therefore, many services have been considering the potential of remote-access therapy, specifically the use of video-conferencing apps. During the covid-19 crisis and beyond, it is of urgent and practical need that we develop more accessible, innovative home-based group interventions to people with dementia that can be delivered remotely. A group at The University of Hong Kong, are undertaking a study entitled 'FaceCog' which involves the delivery of Cognitive Stimulation Therapy (CST) via the video-conferencing application 'Zoom'. CST is an established, evidence-based group intervention shown to improve quality of life and slow down cognitive deterioration in PLWD. In collaboration with the Hong Kong 'FaceCog' team, we propose to deliver a culturally adapted version of their Zoom-CST protocol in the UK in a proof of concept study during the current Covid-19 pandemic. The facecog Zoom-CST protocol is the first virtual CST protocol of its kind that we are aware of. It closely follows the original, evidence-based CST manual that was developed in the UK. It has been slightly adapted to make it useable on a virtual platform and to be culturally sensitive for use in Hong Kong. It incorporates all key elements and principles that have been evidenced to make the treatment effective. As we are delivering it in the UK, we will be using activities from the original manual, in place of the activities that have been adapted for the Hong Kong protocol. For example, we will use British phrases in the word games session rather than Chinese proverbs.
Data on recruitment, attrition, attendance data, focus groups, participant-completed session feedback forms and qualitative post-session interviews, will offer us the opportunity to assess intervention acceptability. Outcomes related to cognition, quality of life and mood will allow us to make inferences about the potential for clinical impacts of such an intervention. Engagement analysis will allow us to explore the potential barriers and facilitators to virtual-delivered CST for this population and highlight any potential adaptations to intervention which may be needed. This project is intended as a preliminary exploration which will pave the way for future intervention-modifications and pilot-studies which can evaluate the potential benefits of 'virtually'-delivered CST.
Read more
This research aims to:
- Modify a pre-existing Zoom-CST protocol (FaceCog HK) to be culturally relevant and deliverable remotely within the UK.
- Modify and develop resources for the groups, along with dementia-friendly 'how to' guides on using the chosen video-conferencing application.
- Consult with stakeholders (including staff working within dementia care - clinical staff, charity organisations, and PLWD and their carers) about the potential foreseen barriers and facilitators to successful implementation of virtual-CST. Two remote, 'virtual' focus groups are proposed, one for professionals, and one for PLWD and/or informal carers.
- Asses virtual CST's feasibility as guided by Orsmond and Cohn's (2015) discussion article on this topic, which identifies objectives of feasibility studies as, an evaluation of recruitment capability and sample characteristics, data collection procedures and outcome measures, the acceptability and suitability of the intervention and study procedures, the resources and ability to manage and implement the study and intervention, participants' responses to the intervention.
- Conditions
- Dementia
- Being tested
- Online 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.
Online Cognitive Stimulation TherapyOther
Participants will attend 14 x 1 hour online CST sessions that involve a variety of activities to stimulate the brain and focus on cognitive strengths based on a variety of themes i.e. childhood, using money, etc. This will aim to be multisensory and give choice and empowerment to participants. Benefits of face to face CST are shown to slow cognitive decline and improve quality of life. Adapting it for online use will investigate whether participants can still benefit in this way.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Attendance at online CST groups Receives: Other: Online Cognitive Stimulation Therapy |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog (adapted for virtual use) - change is being assessed
Assessment of cognitive skills, used in dementia research
Measured: To be completed within one week before and within one week after the intervention
MOCA blind- change is being assessed
Cognitive screening tool
Measured: To be completed within one week before and within one week after the intervention
Geriatric Depression Scale- change is being assessed
Screen for depression in older adults
Measured: To be completed within one week before and within one week after the intervention
QoL-AD- change is being assessed
Quality of Life questionnaire for use in dementia
Measured: To be completed within one week before and within one week after the intervention
Secondary outcomes (1)
Post intervention interviews
Qualitative date on experiences from the group
Measured: Within 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695743
- Sponsor's protocol ID
- 17127/002
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spector A, Abdul Wahab ND, Stott J, Fisher E, Hui EK, Perkins L, Leung WG, Evans R, Wong G, Felstead C. Virtual Group Cognitive Stimulation Therapy for Dementia: Mixed-Methods Feasibility Randomized Controlled Trial. Gerontologist. 2024 Aug 1;64(8):gnae063. doi: 10.1093/geront/gnae063.
PubMed 38843088
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. 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
- NCT04695743
- Acronym / sponsor ID
- 17127/002
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 Jan 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.
People living with dementia (PLWD) often struggle to access services and treatment which may benefit their emotional and cognitive wellbeing, as well as disease progression. Transport provision; hospital access and restricted mobility are barriers that often deny people the opportunity to receive treatment in-line with NICE guidelines. Considering the current Covid-19 pandemic, hospital access and face-to-face treatment is even more limited at present; with services across the UK unable to offer their usual levels of care and support. This is particularly the case for people in vulnerable groups. Therefore, many services have been considering the potential of remote-access therapy, specifically the use of video-conferencing apps. During the covid-19 crisis and beyond, it is of urgent and practical need that we develop more accessible, innovative home-based group interventions to people with dementia that can be delivered remotely. A group at The University of Hong Kong, are undertaking a study entitled 'FaceCog' which involves the delivery of Cognitive Stimulation Therapy (CST) via the video-conferencing application 'Zoom'. CST is an established, evidence-based group intervention shown to improve quality of life and slow down cognitive deterioration in PLWD. In collaboration with the Hong Kong 'FaceCog' team, we propose to deliver a culturally adapted version of their Zoom-CST protocol in the UK in a proof of concept study during the current Covid-19 pandemic. The facecog Zoom-CST protocol is the first virtual CST protocol of its kind that we are aware of. It closely follows the original, evidence-based CST manual that was developed in the UK. It has been slightly adapted to make it useable on a virtual platform and to be culturally sensitive for use in Hong Kong. It incorporates all key elements and principles that have been evidenced to make the treatment effective. As we are delivering it in the UK, we will be using activities from the original manual, in place of the activities that have been adapted for the Hong Kong protocol. For example, we will use British phrases in the word games session rather than Chinese proverbs.
Data on recruitment, attrition, attendance data, focus groups, participant-completed session feedback forms and qualitative post-session interviews, will offer us the opportunity to assess intervention acceptability. Outcomes related to cognition, quality of life and mood will allow us to make inferences about the potential for clinical impacts of such an intervention. Engagement analysis will allow us to explore the potential barriers and facilitators to virtual-delivered CST for this population and highlight any potential adaptations to intervention which may be needed. This project is intended as a preliminary exploration which will pave the way for future intervention-modifications and pilot-studies which can evaluate the potential benefits of 'virtually'-delivered CST.
This research aims to:
- Modify a pre-existing Zoom-CST protocol (FaceCog HK) to be culturally relevant and deliverable remotely within the UK.
- Modify and develop resources for the groups, along with dementia-friendly 'how to' guides on using the chosen video-conferencing application.
- Consult with stakeholders (including staff working within dementia care - clinical staff, charity organisations, and PLWD and their carers) about the potential foreseen barriers and facilitators to successful implementation of virtual-CST. Two remote, 'virtual' focus groups are proposed, one for professionals, and one for PLWD and/or informal carers.
- Asses virtual CST's feasibility as guided by Orsmond and Cohn's (2015) discussion article on this topic, which identifies objectives of feasibility studies as, an evaluation of recruitment capability and sample characteristics, data collection procedures and outcome measures, the acceptability and suitability of the intervention and study procedures, the resources and ability to manage and implement the study and intervention, participants' responses to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online Cognitive Stimulation TherapyAttendance at online CST groups |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must have a clinical diagnosis of dementia and be within the 'mild-moderate' stages of disease progression.
- Must be able to communicate verbally in English.
- Must have capacity to consent to complete measures and to consent to video recording of the individual sessions.
- Must have access to a device capable of video-conferencing and internet at home.
- Must not be accessing any other psychosocial intervention (I.e. psychological therapy) at the time of participation
Key exclusion criteria (5 listed)
- Not having a clinical diagnosis of dementia or being within the 'moderate- sever' stages of disease progression
- Not being able to communicate verbally in English
- Not have the capacity to take consent to participation
- Not have access to a device capable of video-conferencing and internet at home.
- If the person is accessing any other psychosocial intervention (I.e. psychological therapy) at the time of participation
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 |
|---|---|---|
| Online Cognitive Stimulation TherapyParticipants will attend 14 x 1 hour online CST sessions that involve a variety of activities to stimulate the brain and focus on cognitive strengths based on a variety of themes i.e. childhood, using money, etc. This will aim to be multisensory and give choice and empowerment to participants. Benefits of face to face CST are shown to slow cognitive decline and improve quality of life. Adapting it for online use will investigate whether participants can still benefit in this way. | Other | Intervention |
Primary outcome
ADAS-Cog (adapted for virtual use) - change is being assessed
Time frame: To be completed within one week before and within one week after the intervention
Assessment of cognitive skills, used in dementia research
MOCA blind- change is being assessed
Time frame: To be completed within one week before and within one week after the intervention
Cognitive screening tool
Geriatric Depression Scale- change is being assessed
Time frame: To be completed within one week before and within one week after the intervention
Screen for depression in older adults
QoL-AD- change is being assessed
Time frame: To be completed within one week before and within one week after the intervention
Quality of Life questionnaire for use in dementia
1 secondary outcome
Post intervention interviews
Time frame: Within 1 month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 38843088Spector A, Abdul Wahab ND, Stott J, Fisher E, Hui EK, Perkins L, Leung WG, Evans R, Wong G, Felstead C. Virtual Group Cognitive Stimulation Therapy for Dementia: Mixed-Methods Feasibility Randomized Controlled Trial. Gerontologist. 2024 Aug 1;64(8):gnae063. doi: 10.1093/geront/gnae063.
- 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.
Luke Perkins contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Stimulation Therapy in people with Dementia, 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 5 inclusion and 5 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 5 Jan 2021. 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?
Contact Aimee Spector (020 7679 1844 ext. 41844, a.spector@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog (adapted for virtual use) - change is being assessed (time frame: To be completed within one week before and within one week after the intervention). The study lists 4 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 NCT04695743, which also lists 1 linked publication.
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 5 Jan 2021.