NCT03773016

Brief Summary

The prevalence of dementia is rapidly growing worldwide, affecting 46.8 million people in 2015. The 2014 Alzheimer's Society report estimated that 311,730 people with dementia were living in care homes in the United Kingdom (UK). In care homes, people are more likely to be socially isolated and experience a lack of stimulation. It has been argued that access to meaningful activities is of high importance. One strategy that may engage older people in enjoyable leisure activities is the use of touchscreen technology. Previous research has indicated that people with dementia and care staff reported positive experiences when using touchscreen technology, showing improvements in quality of life, relationships and interpersonal interaction. A possible way to engage people with dementia with touchscreen technology could be through the use of the visual arts. Preliminary evidence shows the use of arts with this population to be beneficial in reducing behavioural symptoms, depression and isolation and make people with dementia more able to express feelings. The use of visual art activities in touchscreen technology is a promising idea, as positive results from interventions using these activities independently can be found in scientific literature. This intervention will consist of the use of two different visual art apps on touchscreen tablets with people with dementia living in care homes. Study data collection will take 8 weeks; four weeks will involve the execution of the intervention and four weeks for measurements. Participants will be supported to use the app twice-weekly, with a maximum of 8 individual sessions. So far, very little research on the benefits of visual art interventions on touchscreen devices has been made. Thus, there is a need to have more research on this topic. This study will add to research on this field, and its results could be valuable to care staff and people with dementia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

March 22, 2019

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

November 26, 2018

Last Update Submit

March 20, 2019

Conditions

Keywords

care homevisual artapptouchscreen technologydementia

Outcome Measures

Primary Outcomes (1)

  • Change on Wellbeing

    Assessed by Greater Cincinnati Chapter Wellbeing Observation Tool (observational tool to evaluate wellbeing during art interventions) - 19 items with domains of wellbeing and ill-being. Each item can be scored from 0 (never) to 4 (always).

    1 month

Study Arms (2)

Art apps - Group 1 (A-B)

EXPERIMENTAL

Cross-over use of two different visual art apps on touchscreen tablets (App A and App B)

Behavioral: Art apps

Art apps - Group 2 (B-A)

EXPERIMENTAL

Cross-over use of two different visual art apps on touchscreen tablets (App B and App A)

Behavioral: Art apps

Interventions

Art appsBEHAVIORAL

Participants will be split into two groups of 6 participants; each group will use one app for two weeks and then change to the other app for another 2 weeks. Participants will be supported to use the app twice a week, with a maximum of 8 individual sessions over the four weeks. The intervention will be delivered to the participants at a quiet room in the care home by two co-investigators, one will be the facilitator, and the other one will be the observer. The intervention is a 30-minutes of individual sessions, with 10 minutes of app use. The additional 20 minutes will include the setup of the equipment and preparation of the participant at the beginning of the session; and questions for the participants at the end.

Art apps - Group 1 (A-B)Art apps - Group 2 (B-A)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with dementia:
  • To be living in a Care Home in Nottinghamshire;
  • To have mild dementia \[21 to 26 points in the Mini-Mental State Examination (MMSE) or a comparable score on the MoCA from 16 to 20 points\] or moderate dementia \[10 to 20 points on the MMSE or a comparable score on the MoCA from 2 to 15 points\];
  • To be willing to use apps on touchscreen tablets;
  • Ability to give informed consent or have a consultee that provides advice;
  • Ability to speak and understand English.
  • Nursing home staff:
  • To be involved in the care of at least one of the participants;
  • Ability to speak and understand English.

You may not qualify if:

  • Participants with dementia:
  • To have conditions that could limit hand-control (e.g. stroke, Parkinson's disease);
  • To have severe visual or hearing impairments;
  • Simultaneous participation in any other interventional study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (21)

  • Astell AJ, Joddrell P, Groenewoud H, de Lange J, Goumans M, Cordia A, Schikhof Y. Does familiarity affect the enjoyment of touchscreen games for people with dementia? Int J Med Inform. 2016 Jul;91:e1-8. doi: 10.1016/j.ijmedinf.2016.02.001. Epub 2016 Feb 12.

    PMID: 26897552BACKGROUND
  • Brooker DJ, Woolley RJ, Lee D. Enriching opportunities for people living with dementia in nursing homes: an evaluation of a multi-level activity-based model of care. Aging Ment Health. 2007 Jul;11(4):361-70. doi: 10.1080/13607860600963679.

    PMID: 17612800BACKGROUND
  • Cohen-Mansfield J, Dakheel-Ali M, Thein K, Marx MS. The impact of stimulus attributes on engagement of nursing home residents with dementia. Arch Gerontol Geriatr. 2009 Jul-Aug;49(1):1-6. doi: 10.1016/j.archger.2008.04.002. Epub 2008 Jul 7.

    PMID: 18602707BACKGROUND
  • Dichter, M., Ettema, T., Schwab, C., Meyer, G., Bartholomeyczik, S., Halek, M., & Dröes, R. (2016). QUALIDEM-user guide. DZNE/VUmc, Witten/Amsterdam.

    BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND
  • Gross SM, Danilova D, Vandehey MA, Diekhoff GM. Creativity and dementia: does artistic activity affect well-being beyond the art class? Dementia (London). 2015 Jan;14(1):27-46. doi: 10.1177/1471301213488899. Epub 2013 May 22.

    PMID: 24339088BACKGROUND
  • Han, A., Radel, J., McDowd, J. M., & Sabata, D. (2016). The Benefits of Individualized Leisure and Social Activity Interventions for People with Dementia: A Systematic Review. Activities, Adaptation & Aging, 40(3), 219-265. doi:10.1080/01924788.2016.1199516

    BACKGROUND
  • Hannemann BT. Creativity with dementia patients. Can creativity and art stimulate dementia patients positively? Gerontology. 2006;52(1):59-65. doi: 10.1159/000089827.

    PMID: 16439826BACKGROUND
  • Joddrell, P. (2017). Investigating the potential of touchscreen technology to create opportunities for independent activity with people living with dementia. University of Sheffield.

    BACKGROUND
  • Joddrell, P., Hernandez, A., & Astell, A. J. (2016). Identifying Existing, Accessible Touchscreen Games for People Living with Dementia. Computers Helping People with Special Needs, Icchp 2016, Pt I, 9758, 509-514. doi:10.1007/978-3-319-41264-1_69

    BACKGROUND
  • Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.

    PMID: 16136845BACKGROUND
  • Leng FY, Yeo D, George S, Barr C. Comparison of iPad applications with traditional activities using person-centred care approach: impact on well-being for persons with dementia. Dementia (London). 2014 Mar 1;13(2):265-73. doi: 10.1177/1471301213494514. Epub 2013 Jul 19.

    PMID: 24339097BACKGROUND
  • Leuty V, Boger J, Young L, Hoey J, Mihailidis A. Engaging older adults with dementia in creative occupations using artificially intelligent assistive technology. Assist Technol. 2013 Summer;25(2):72-9. doi: 10.1080/10400435.2012.715113.

    PMID: 23923689BACKGROUND
  • Mihailidis, A., Blunsden, S., Boger, J., Richards, B., Zutis, K., Young, L., & Hoey, J. (2010). Towards the development of a technology for art therapy and dementia: Definition of needs and design constraints. The Arts in Psychotherapy, 37(4), 293-300.

    BACKGROUND
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND
  • NICE. (2011). Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease. Retrieved from https://www.nice.org.uk/guidance/ta217

    BACKGROUND
  • Smith, S. K. (2015). Exploring the potential of touch-screen computer technology in promoting enjoyable activities with people living with dementia: A visual ethnography. University of Sheffield.

    BACKGROUND
  • Trzepacz PT, Hochstetler H, Wang S, Walker B, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Relationship between the Montreal Cognitive Assessment and Mini-mental State Examination for assessment of mild cognitive impairment in older adults. BMC Geriatr. 2015 Sep 7;15:107. doi: 10.1186/s12877-015-0103-3.

    PMID: 26346644BACKGROUND
  • Tyack C, Camic PM. Touchscreen interventions and the well-being of people with dementia and caregivers: a systematic review. Int Psychogeriatr. 2017 Aug;29(8):1261-1280. doi: 10.1017/S1041610217000667. Epub 2017 Apr 27.

    PMID: 28446258BACKGROUND
  • Tyack C, Camic PM, Heron MJ, Hulbert S. Viewing Art on a Tablet Computer: A Well-Being Intervention for People With Dementia and Their Caregivers. J Appl Gerontol. 2017 Jul;36(7):864-894. doi: 10.1177/0733464815617287. Epub 2015 Dec 16.

    PMID: 26675353BACKGROUND
  • Upton, D., Upton, P., Jones, T., Jutlla, K., Brooker, D., & Grove, H. (2011). Evaluation of the impact of touch screen technology on people with dementia and their carers within care home settings. UK: University of Worcester.

    BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The intervention activity will consist of the cross-over use of two different visual art apps in touchscreen tablets with people with mild to moderate dementia that lives in care homes. The study will take place in a nursing home in Nottinghamshire and will involve 12 residents of the care home with dementia and up to 12 staff members that are involved in participants' care. Study data collection will take 8 weeks; four weeks will involve the execution of the intervention and four weeks for additional measurements (collect consent, screening and end measures). Participants will be split into two groups of 6 participants; each group will use one app for two weeks and then change to the other app for another 2 weeks. Participants will be supported to use the app twice a week, with a maximum of 8 individual sessions over the four weeks. The data collection will consist of the observation of the activity and on the use of dementia-specific instruments and questionnaires.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

December 12, 2018

Study Start

February 20, 2019

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

March 22, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations