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Trial record 2 of 4 for:    12948999 [PUBMED-IDS]

iCST Web-application for People With Dementia

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ClinicalTrials.gov Identifier: NCT03282877
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Dementia Moderate Dementia Behavioral: iCST web-application Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapting Individual Cognitive Stimulation Therapy (iCST) for Delivery by a Web-application
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: iCST web-application
A computerised cognitive stimulation programme consisting of 21 sessions.
Behavioral: iCST web-application
The iCST web-application will be delivered by a carer in regular contact with the person with dementia (family carer, a close friend, or a volunteer befriender) for 1.5 hours a week. It is up to the carer to distribute the time in a matter that is convenient to them (e.g. two long sessions of 45 minutes or 3 shorter sessions of 30 minutes). Participants will be asked to use the web-application for a duration of 11 weeks at their homes. Each session will consist of structured cognitive stimulation aided by the use of multimedia. After completing each session, participants will be guided to a new screen on the web-application in which they will be asked to briefly reflect on the session and provide us with feedback.

No Intervention: Treatment as usual (TAU)
The control group will consist of a treatment-as-usual group and will not receive any additional intervention.



Primary Outcome Measures :
  1. Change in cognition (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    ADAS-Cog: to measure the severity of the cognitive symptoms (memory, language, praxis, attention and other cognitive abilities)

  2. Change in quality of life (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    QoL-AD: self reporting questionnaire to investigate: physical health, energy, mood, living situation, memory, marriage, friends, chores, fun, money, self and life).

  3. Change in general health outcome (carer) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    EQ-5D: An instrument used to measure health outcome, it provides a descriptive profile for health status. It evaluates quality of life in carers.


Secondary Outcome Measures :
  1. Depression (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    CSDD: to measure depressive symptoms: mood-related signs, behavioural disturbances, physical signs, biological functions and ideational disturbances

  2. Behavioural symptoms (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    NPI: to asses 10 behavioural disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy and aberrant motor activity.

  3. Activities of daily living (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    BADLS: BADLS is an instrument consisting of 20 daily-living abilities (basic and instrumental activities)

  4. Relation between person with dementia and carer (both) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    QPCR: a measure of relationship quality which will be completed by both the person with dementia and the carer

  5. Depression/anxiety (carer) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]
    HADS: is a useful measure anxiety and depression for carer. It consists of 14 questions (7 for anxiety and 7 for depression).


Other Outcome Measures:
  1. Computer use self efficacy [ Time Frame: Pre-intervention (baseline) ]
    CUSE: will be used to assess self-efficacy beliefs in the context of computer/tablet use

  2. System usability [ Time Frame: 11 weeks post baseline ]
    SUS: is a widely-used questionnaire measuring the usability of a technology-based tool e.g. a computer program or other device.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282877


Contacts
Contact: Harleen Rai, MSc. +441157484252 Harleen.Rai@nottingham.ac.uk
Contact: Martin Orrell, MD, PhD +441158231291 M.Orrell@nottingham.ac.uk

Locations
United Kingdom
Nottinghamshire Healthcare NHS Trust Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Martin Orrell, MD, PhD University of Nottingham
Study Director: Justine Schneider, PhD University of Nottingham
Principal Investigator: Harleen Rai, MSc. University of Nottingham
Study Director: Lauren Yates, PhD University of Nottingham

Publications:
Hodge, S., Hailey, E & Orrell, M. (eds) (2014). Memory Services National Accreditation Programme - Standards for Memory Services (4th Edition). London: Royal College of Psychiatrists.
Spector, A., Thorgrimsen, L., Woods, B., & Orrell, M. (2006). Making a difference. London: Hawker Publications.

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03282877     History of Changes
Other Study ID Numbers: iCST web-application
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases