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Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study (V-iCST)

Primary Purpose

Dementia, Dementia, Vascular, Dementia, Mixed

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Individual Cognitive Simulation Therapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of dementia, according to the DSM-IV
  2. MoCA - BLIND ≥ 2
  3. Age ≥ 18
  4. Ability to communicate in English
  5. Ability to complete outcome measures
  6. Capacity to consent
  7. Consent to video-conferencing
  8. Access to video-conferencing

Exclusion Criteria:

1) Illness and disability that affects participation (as deemed by researcher)

Sites / Locations

  • UCL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Individual Cognitive Stimulation Therapy

Treatment as usual

Arm Description

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.

Standard care.

Outcomes

Primary Outcome Measures

Recruitment (feasibility of V-iCST)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Retention rate (feasibility of V-iCST)
Retention rate of at least 75% of participants 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.
Negative of adverse events (acceptability of V-iCST)
Any negative or adverse events related to the intervention
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 23, 2021
Last Updated
March 24, 2022
Sponsor
University College, London
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04828434
Brief Title
Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study
Acronym
V-iCST
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
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia, Mild, Dementia Moderate, Dementia Alzheimers, Dementia of Alzheimer Type, Dementia, Multi-Infarct, Dementia Frontotemporal
Keywords
Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-blind. The assessor will be blinded. Due to the nature of the intervention, the facilitator, and participants cannot be blinded.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Individual Cognitive Stimulation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Standard care.
Intervention Type
Other
Intervention Name(s)
Virtual Individual Cognitive Simulation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment (feasibility of V-iCST)
Description
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Time Frame
Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Title
Retention rate (feasibility of V-iCST)
Description
Retention rate of at least 75% of participants at 9-week follow-up.
Time Frame
Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Title
Attendance and retention rate (acceptability of V-iCST)
Description
Overall attendance and retention rates among the participants (60%) at 9-week follow-up.
Time Frame
Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Title
Negative of adverse events (acceptability of V-iCST)
Description
Any negative or adverse events related to the intervention
Time Frame
Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Title
Fidelity (acceptability of V-iCST)
Description
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.
Time Frame
Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Secondary Outcome Measure Information:
Title
Change in cognitive function
Description
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.
Time Frame
Pre-test (baseline: week 0) and post test (week 9)
Title
Change in cognitive function
Description
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.
Time Frame
Pre-test (baseline: week 0) and post test (week 9)
Title
Change in quality of life
Description
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.
Time Frame
Pre-test (baseline: week 0) and post test (week 9)
Title
Change in mood
Description
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.
Time Frame
Pre-test (baseline: week 0) and post test (week 9)
Title
Change in communication
Description
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.
Time Frame
Pre-test (baseline: week 0) and post test (week 9)
Title
Change in engagement
Description
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.
Time Frame
Evaluated by an independent researcher through video recordings; up to 48 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1) Illness and disability that affects participation (as deemed by researcher)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Spector, PhD, DClinPsy
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Upon study completion.
IPD Sharing Access Criteria
Email authors.
Citations:
PubMed Identifier
12021425
Citation
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.
Results Reference
background
PubMed Identifier
6496779
Citation
Rosen 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.
Results Reference
background
PubMed Identifier
16136845
Citation
Kinney 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.
Results Reference
background
Citation
Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
Results Reference
background
Citation
Yesavage JA, Sheikh JI. Geriatric Depression Scale (GDS) Recent evidence and development of shorter version. Clin Gerontol. 1986;5(1-2):165-73.
Results Reference
background
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
International Cognitive Stimulation Therapy Centre Website
Available IPD/Information URL
http://www.ucl.ac.uk/international-cognitive-stimulation-therapy

Learn more about this trial

Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study

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