Mild Dementia Clinical Trial
Official title:
Adapting Individual Cognitive Stimulation Therapy (iCST) for Delivery by a Web-application
Verified date | November 2020 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the UK, over 670,000 older people are living with dementia which has a substantial, multi-level impact on society, the person with dementia, and their carers. There is a need for an increase in the availability of psychological therapies since people with dementia can face difficulties with staying mentally stimulated and engaged. Cognitive Stimulation Therapy (CST) offers a person based approach and can help to relieve some of these problems. It is a brief manualised evidence based psychological treatment for people with mild to moderate dementia which has shown to improve cognition and quality of life. CST is currently available in both a group and individualised format called iCST. It is worthwhile to explore a computerised version of iCST since it would take together the added value of computer use and the beneficial effects of iCST which might produce combined, positive effects on cognition and quality of life. The investigators have spoken to people with dementia and their carers who are keen on using technology to stay mentally active and stimulated. This study sets out to develop and evaluate the potential benefits of an iCST web-application within a feasibility study. The effects on cognition and quality of life between (a) usual care and (b) iCST web-application over 11 weeks will be compared. A web-application is a website which can easily be accessed on and is compatible with computers and tablets. In order to create the most appropriate and practical web-application, the research team will work closely together with people with dementia, their carers, and the software company. An iCST web-application will compliment traditional CST by making it even more accessible since technology users will be able to access it easily on their device. Furthermore, a computerised version of iCST will by highly relevant for upcoming generations who have grown up with the use of technology.
Status | Completed |
Enrollment | 43 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: Person with dementia: - Meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for dementia (American Psychiatric Association, 2013). - Score 10 or above on the Mini Mental State Examination (MMSE) (Folstein, Folstein, & McHugh, 1975) or score of 16 or above on the Montreal Cognitive Assessment (MoCA) (Trzepacz et al., 2015) where available. - Some ability to communicate and understand (e.g. ability to give informed consent) - Ability to speak and understand English - See/hear well enough to participate - No major physical illness or disability affecting their participation - Age range: 50 years - no maximum age limit - Availability of a tablet to the person with dementia and carer - Availability of a carer (or friend/befriender) to participate in the focus groups, interviews and iCST web-app sessions Carer: - Minimum age: 21 - Ability to speak and understand English - See/hear well enough to participate - No major physical illness or disability affecting their participation Exclusion criteria Person with dementia and carer: - Concurrent participation in any other interventional study for people with dementia/carers |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Derbyshire Healthcare NHS Foundation Trust | Derby | Derbyshire |
United Kingdom | Leicestershire Partnership NHS Trust | Leicester | Leicestershire |
United Kingdom | Lincolnshire Partnership NHS Foundation Trust | Lincoln | Lincolnshire |
United Kingdom | Nottinghamshire Healthcare NHS Trust | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Computer use self efficacy | CUSE: will be used to assess self-efficacy beliefs in the context of computer/tablet use | Pre-intervention (baseline) | |
Other | System usability | SUS: is a widely-used questionnaire measuring the usability of a technology-based tool e.g. a computer program or other device. | 11 weeks post baseline | |
Primary | Change in cognition (person with dementia) | ADAS-Cog: to measure the severity of the cognitive symptoms (memory, language, praxis, attention and other cognitive abilities) | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Primary | Change in quality of life (person with dementia) | QoL-AD: self reporting questionnaire to investigate: physical health, energy, mood, living situation, memory, marriage, friends, chores, fun, money, self and life). | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Primary | Change in general health outcome (carer) | EQ-5D: An instrument used to measure health outcome, it provides a descriptive profile for health status. It evaluates quality of life in carers. | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Secondary | Depression (person with dementia) | CSDD: to measure depressive symptoms: mood-related signs, behavioural disturbances, physical signs, biological functions and ideational disturbances | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Secondary | Behavioural symptoms (person with dementia) | NPI: to asses 10 behavioural disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy and aberrant motor activity. | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Secondary | Activities of daily living (person with dementia) | BADLS: BADLS is an instrument consisting of 20 daily-living abilities (basic and instrumental activities) | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Secondary | Relation between person with dementia and carer (both) | QPCR: a measure of relationship quality which will be completed by both the person with dementia and the carer | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline | |
Secondary | Depression/anxiety (carer) | HADS: is a useful measure anxiety and depression for carer. It consists of 14 questions (7 for anxiety and 7 for depression). | Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline |
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