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Group CST Using Zoom: A Proof of Concept Study

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ClinicalTrials.gov Identifier: NCT04695743
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Dementia Other: Online Cognitive Stimulation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intervention
Attendance at online CST groups
Other: Online Cognitive Stimulation Therapy
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.

No Intervention: Control
Treatment as usual



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Post intervention interviews [ Time Frame: Within 1 month post intervention ]
    Qualitative date on experiences from the group



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695743


Contacts
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Contact: Aimee Spector 020 7679 1844 ext 41844 a.spector@ucl.ac.uk
Contact: Luke Perkins luke.perkins.15@ucl.ac.uk

Locations
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United Kingdom
University College London Recruiting
London, United Kingdom, WC1E 6BT
Contact: Aimee Spector    020 7679 1844 ext 41844    a.spector@ucl.ac.uk   
Sub-Investigator: Luke Perkins         
Sub-Investigator: Cerne Felstead         
Sub-Investigator: Nur Diyanah Abdul Wahab         
Sub-Investigator: Wing Gi Leung         
Sponsors and Collaborators
University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04695743    
Other Study ID Numbers: 17127/002
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders