Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study

Study Overview
=================
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.

Official Title
-----------------
Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic

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

Intervention / Treatment
-----------------
* Other: Virtual Individual Cognitive Simulation Therapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Individual Cognitive Stimulation Therapy<br>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. | Other: Virtual Individual Cognitive Simulation Therapy<br>* 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.<br>|
| No Intervention: Treatment as usual<br>Standard care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment (feasibility of V-iCST) | Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period. | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | 
| Retention rate (feasibility of V-iCST) | Retention rate of at least 75% of participants at 9-week follow-up. | Descriptive data will be collected during the study and analyzed post-intervention; 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. | Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up | 
| Negative of adverse events (acceptability of V-iCST) | Any negative or adverse events related to the intervention | Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years | 
| 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. | Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-test (baseline: week 0) and post test (week 9) | 
| 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. | Pre-test (baseline: week 0) and post test (week 9) | 
| 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. | Pre-test (baseline: week 0) and post test (week 9) | 
| 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. | Pre-test (baseline: week 0) and post test (week 9) | 
| 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. | Pre-test (baseline: week 0) and post test (week 9) | 
| 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. | Evaluated by an independent researcher through video recordings; up to 48 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions