Clinical trial NCT04828434: Virtual Individual Cognitive Stimulation Therapy: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2021-04-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment (feasibility of V-iCST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
measure: Retention rate (feasibility of V-iCST)
timeFrame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
measure: Attendance and retention rate (acceptability of V-iCST)
timeFrame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
measure: Negative of adverse events (acceptability of V-iCST)
timeFrame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
measure: Fidelity (acceptability of V-iCST)
timeFrame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Secondary outcomes:
measure: Change in cognitive function
timeFrame: Pre-test (baseline: week 0) and post test (week 9)
measure: Change in cognitive function
timeFrame: Pre-test (baseline: week 0) and post test (week 9)
measure: Change in quality of life
timeFrame: Pre-test (baseline: week 0) and post test (week 9)
measure: Change in mood
timeFrame: Pre-test (baseline: week 0) and post test (week 9)
measure: Change in communication
timeFrame: Pre-test (baseline: week 0) and post test (week 9)
measure: Change in engagement
timeFrame: Evaluated by an independent researcher through video recordings; up to 48 months.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL
Study officials:
affiliation: UCL
name: Aimee Spector, PhD, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References:
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