Group CST Using Zoom: A Proof of Concept Study
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online Cognitive Stimulation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dementia
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria
- 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
Sites / Locations
- University College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Attendance at online CST groups
Treatment as usual
Outcomes
Primary Outcome Measures
ADAS-Cog (adapted for virtual use) - change is being assessed
Assessment of cognitive skills, used in dementia research
MOCA blind- change is being assessed
Cognitive screening tool
Geriatric Depression Scale- change is being assessed
Screen for depression in older adults
QoL-AD- change is being assessed
Quality of Life questionnaire for use in dementia
Secondary Outcome Measures
Post intervention interviews
Qualitative date on experiences from the group
Full Information
NCT ID
NCT04695743
First Posted
December 11, 2020
Last Updated
January 4, 2021
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04695743
Brief Title
Group CST Using Zoom: A Proof of Concept Study
Official Title
Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Attendance at online CST groups
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Other
Intervention Name(s)
Online Cognitive Stimulation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADAS-Cog (adapted for virtual use) - change is being assessed
Description
Assessment of cognitive skills, used in dementia research
Time Frame
To be completed within one week before and within one week after the intervention
Title
MOCA blind- change is being assessed
Description
Cognitive screening tool
Time Frame
To be completed within one week before and within one week after the intervention
Title
Geriatric Depression Scale- change is being assessed
Description
Screen for depression in older adults
Time Frame
To be completed within one week before and within one week after the intervention
Title
QoL-AD- change is being assessed
Description
Quality of Life questionnaire for use in dementia
Time Frame
To be completed within one week before and within one week after the intervention
Secondary Outcome Measure Information:
Title
Post intervention interviews
Description
Qualitative date on experiences from the group
Time Frame
Within 1 month post intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee Spector
Phone
020 7679 1844
Ext
41844
Email
a.spector@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Perkins
Email
luke.perkins.15@ucl.ac.uk
Facility Information:
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Spector
Phone
020 7679 1844
Ext
41844
Email
a.spector@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Luke Perkins
First Name & Middle Initial & Last Name & Degree
Cerne Felstead
First Name & Middle Initial & Last Name & Degree
Nur Diyanah Abdul Wahab
First Name & Middle Initial & Last Name & Degree
Wing Gi Leung
12. IPD Sharing Statement
Plan to Share IPD
No
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Group CST Using Zoom: A Proof of Concept Study
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