Dementia, Dementia Alzheimers, Dementia Frontal, Dementia Frontotemporal, Dementia, Mild, Dementia, Mixed, Dementia Moderate, Dementia, Multi-Infarct, Dementia of Alzheimer Type, Dementia, Vascular, Dementia With Lewy Bodies
Conditions
Keywords
Dementia, Randomized Controlled Trial, Cognitive Stimulation, Mild to Moderate Dementia, Teletherapy, Psychosocial Interventions
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.
Interventions
OTHERVirtual Individual Cognitive Simulation Therapy
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.
Sponsors
The University of Hong Kong
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity (acceptability of V-iCST) | Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years | 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. |
| Recruitment (feasibility of V-iCST) | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period. |
| Retention rate (feasibility of V-iCST) | Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up | Retention rate of at least 75% of participants at 9-week follow-up. |
| Attendance and retention rate (acceptability of V-iCST) | Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up | Overall attendance and retention rates among the participants (60%) at 9-week follow-up. |
| Negative of adverse events (acceptability of V-iCST) | Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years | Any negative or adverse events related to the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | Pre-test (baseline: week 0) and post test (week 9) | 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 quality of life | Pre-test (baseline: week 0) and post test (week 9) | 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 | Pre-test (baseline: week 0) and post test (week 9) | 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 | Pre-test (baseline: week 0) and post test (week 9) | 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 | Evaluated by an independent researcher through video recordings; up to 48 months. | 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. |
Countries
United Kingdom
Outcome results
None listed