iCST Web-application for People With Dementia

NCT03282877 | Completed

• 1 other identifier: iCST web-application
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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.

Conditions

Mild Dementia; Moderate Dementia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Depression (person with dementia)

  Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline

• Behavioural symptoms (person with dementia)

  Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline

• Activities of daily living (person with dementia)

  Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline

• Relation between person with dementia and carer (both)

  Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline

• Depression/anxiety (carer)

  Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline

Other Outcomes (2)

• Computer use self efficacy

  Pre-intervention (baseline)

• System usability

  11 weeks post baseline

Study Arms (2)

iCST web-application

EXPERIMENTAL

A computerised cognitive stimulation programme consisting of 21 sessions.

Behavioral: iCST web-application

Treatment as usual (TAU)

NO INTERVENTION

The control group will consist of a treatment-as-usual group and will not receive any additional intervention.

Interventions

iCST web-application BEHAVIORAL

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.

iCST web-application

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Person with dementia and carer:
• \- Concurrent participation in any other interventional study for people with dementia/carers

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (4)

Derbyshire Healthcare NHS Foundation Trust

Derby, Derbyshire, DE22 3LZ, United Kingdom

Location

Leicestershire Partnership NHS Trust

Leicester, Leicestershire, LE2 2PL, United Kingdom

Location

Lincolnshire Partnership NHS Foundation Trust

Lincoln, Lincolnshire, LN1 1EJ, United Kingdom

Location

Nottinghamshire Healthcare NHS Trust

Nottingham, Nottinghamshire, NG7 2TU, United Kingdom

Location

Related Publications (13)

• Xavier AJ, d'Orsi E, de Oliveira CM, Orrell M, Demakakos P, Biddulph JP, Marmot MG. English Longitudinal Study of Aging: can Internet/E-mail use reduce cognitive decline? J Gerontol A Biol Sci Med Sci. 2014 Sep;69(9):1117-21. doi: 10.1093/gerona/glu105.

  PMID: 25116923 BACKGROUND

• Almeida OP, Yeap BB, Alfonso H, Hankey GJ, Flicker L, Norman PE. Older men who use computers have lower risk of dementia. PLoS One. 2012;7(8):e44239. doi: 10.1371/journal.pone.0044239. Epub 2012 Aug 28.

  PMID: 22937167 BACKGROUND

• Garcia-Casal JA, Loizeau A, Csipke E, Franco-Martin M, Perea-Bartolome MV, Orrell M. Computer-based cognitive interventions for people living with dementia: a systematic literature review and meta-analysis. Aging Ment Health. 2017 May;21(5):454-467. doi: 10.1080/13607863.2015.1132677. Epub 2016 Jan 25.

  PMID: 26806365 BACKGROUND

• Tarraga L, Boada M, Modinos G, Espinosa A, Diego S, Morera A, Guitart M, Balcells J, Lopez OL, Becker JT. A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2006 Oct;77(10):1116-21. doi: 10.1136/jnnp.2005.086074. Epub 2006 Jul 4.

  PMID: 16820420 BACKGROUND

• Hodge, S., Hailey, E & Orrell, M. (eds) (2014). Memory Services National Accreditation Programme - Standards for Memory Services (4th Edition). London: Royal College of Psychiatrists.

  BACKGROUND

• Spector, A., Thorgrimsen, L., Woods, B., & Orrell, M. (2006). Making a difference. London: Hawker Publications.

  BACKGROUND

• Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.

  PMID: 12948999 BACKGROUND

• Orrell M, Yates L, Leung P, Kang S, Hoare Z, Whitaker C, Burns A, Knapp M, Leroi I, Moniz-Cook E, Pearson S, Simpson S, Spector A, Roberts S, Russell I, de Waal H, Woods RT, Orgeta V. The impact of individual Cognitive Stimulation Therapy (iCST) on cognition, quality of life, caregiver health, and family relationships in dementia: A randomised controlled trial. PLoS Med. 2017 Mar 28;14(3):e1002269. doi: 10.1371/journal.pmed.1002269. eCollection 2017 Mar.

  PMID: 28350796 BACKGROUND

• Yates LA, Orrell M, Spector A, Orgeta V. Service users' involvement in the development of individual Cognitive Stimulation Therapy (iCST) for dementia: a qualitative study. BMC Geriatr. 2015 Feb 6;15:4. doi: 10.1186/s12877-015-0004-5.

  PMID: 25655940 BACKGROUND

• Orrell M, Aguirre E, Spector A, Hoare Z, Woods RT, Streater A, Donovan H, Hoe J, Knapp M, Whitaker C, Russell I. Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial. Br J Psychiatry. 2014 Jun;204(6):454-61. doi: 10.1192/bjp.bp.113.137414. Epub 2014 Mar 27.

  PMID: 24676963 BACKGROUND

• Yates LA, Leung P, Orgeta V, Spector A, Orrell M. The development of individual cognitive stimulation therapy (iCST) for dementia. Clin Interv Aging. 2014 Dec 30;10:95-104. doi: 10.2147/CIA.S73844. eCollection 2015.

  PMID: 25565792 BACKGROUND

• Rai HK, Schneider J, Orrell M. An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT). Clin Interv Aging. 2021 Dec 22;16:2079-2094. doi: 10.2147/CIA.S323994. eCollection 2021.

  PMID: 35221680 DERIVED

• Rai HK, Schneider J, Orrell M. An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 8;10(4):e24628. doi: 10.2196/24628.

  PMID: 33830058 DERIVED

Study Officials

• Martin Orrell, MD, PhD

  University of Nottingham

  STUDY CHAIR

• Justine Schneider, PhD

  University of Nottingham

  STUDY DIRECTOR

• Harleen Rai, MSc.

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Lauren Yates, PhD

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: September 14, 2017
• Study Start: May 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)