Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Attendance and retention rate (acceptability of V-iCST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blind. The assessor will be blinded. Due to the nature of the intervention, the facilitator, and participants cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia, according to the DSM-IV
- •MoCA - BLIND ≥ 2
- •Ability to communicate in English
- •Ability to complete outcome measures
- •Capacity to consent
- •Consent to video-conferencing
- •Access to video-conferencing
排除标准
- •Illness and disability that affects participation (as deemed by researcher)
研究组 & 干预措施
Virtual Individual Cognitive Stimulation Therapy
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.
干预措施: Virtual Individual Cognitive Simulation Therapy (Other)
Treatment as usual
Standard care.
结局指标
主要结局
Attendance and retention rate (acceptability of V-iCST)
时间窗: 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.
Recruitment (feasibility of V-iCST)
时间窗: 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.
Fidelity (acceptability of V-iCST)
时间窗: 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.
Retention rate (feasibility of V-iCST)
时间窗: 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.
Negative of adverse events (acceptability of V-iCST)
时间窗: 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
次要结局
- Change in cognitive function(Pre-test (baseline: week 0) and post test (week 9))
- Change in quality of life(Pre-test (baseline: week 0) and post test (week 9))
- Change in communication(Pre-test (baseline: week 0) and post test (week 9))
- Change in engagement(Evaluated by an independent researcher through video recordings; up to 48 months.)
- Change in mood(Pre-test (baseline: week 0) and post test (week 9))