NCT04695743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

December 11, 2020

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • ADAS-Cog (adapted for virtual use) - change is being assessed

    Assessment of cognitive skills, used in dementia research

    To be completed within one week before and within one week after the intervention

  • MOCA blind- change is being assessed

    Cognitive screening tool

    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

    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

    To be completed within one week before and within one week after the intervention

Secondary Outcomes (1)

  • Post intervention interviews

    Within 1 month post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Attendance at online CST groups

Other: Online Cognitive Stimulation Therapy

Control

NO INTERVENTION

Treatment as usual

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Luke Perkins

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

January 5, 2021

Study Start

September 1, 2020

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations