<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773016</url>
  </required_header>
  <id_info>
    <org_study_id>18080</org_study_id>
    <nct_id>NCT03773016</nct_id>
  </id_info>
  <brief_title>Touchscreen Technology and Art for People With Dementia in Care Homes</brief_title>
  <official_title>Using Computer Technology to Enable Arts and Crafts for People With Dementia in Care Homes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of dementia is rapidly growing worldwide, affecting 46.8 million people in&#xD;
      2015. The 2014 Alzheimer's Society report estimated that 311,730 people with dementia were&#xD;
      living in care homes in the United Kingdom (UK). In care homes, people are more likely to be&#xD;
      socially isolated and experience a lack of stimulation. It has been argued that access to&#xD;
      meaningful activities is of high importance. One strategy that may engage older people in&#xD;
      enjoyable leisure activities is the use of touchscreen technology. Previous research has&#xD;
      indicated that people with dementia and care staff reported positive experiences when using&#xD;
      touchscreen technology, showing improvements in quality of life, relationships and&#xD;
      interpersonal interaction. A possible way to engage people with dementia with touchscreen&#xD;
      technology could be through the use of the visual arts. Preliminary evidence shows the use of&#xD;
      arts with this population to be beneficial in reducing behavioural symptoms, depression and&#xD;
      isolation and make people with dementia more able to express feelings. The use of visual art&#xD;
      activities in touchscreen technology is a promising idea, as positive results from&#xD;
      interventions using these activities independently can be found in scientific literature.&#xD;
      This intervention will consist of the use of two different visual art apps on touchscreen&#xD;
      tablets with people with dementia living in care homes. Study data collection will take 8&#xD;
      weeks; four weeks will involve the execution of the intervention and four weeks for&#xD;
      measurements. Participants will be supported to use the app twice-weekly, with a maximum of 8&#xD;
      individual sessions. So far, very little research on the benefits of visual art interventions&#xD;
      on touchscreen devices has been made. Thus, there is a need to have more research on this&#xD;
      topic. This study will add to research on this field, and its results could be valuable to&#xD;
      care staff and people with dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SCIENTIFIC JUSTIFICATION:&#xD;
&#xD;
      People with dementia that live in care homes are more prone to experience a lack of&#xD;
      stimulation and be socially isolated. Activities that are likely to be beneficial for people&#xD;
      with dementia are social and leisure activities, as the activities promote engagement and&#xD;
      improve affect. It has been argued that these activities should be of high importance in care&#xD;
      settings and that care home residents living with dementia should have access to meaningful&#xD;
      activities and are supported when engaging with the activities.&#xD;
&#xD;
      The use of touchscreen technology is one strategy that may possibly engage older people in&#xD;
      enjoyable leisure activities. In past research, people with dementia and staff reported&#xD;
      positive experiences with the use of technology in previous research that evaluate the&#xD;
      impacts of touchscreen technology in care homes. This same research also showed supportive&#xD;
      evidence for the positive contribution of the touchscreen technology for improvements in&#xD;
      quality of life, relationships and interpersonal interactions. A literature review from 2017&#xD;
      on the use of touchscreen technology by people with dementia and its impact on wellbeing also&#xD;
      shows supportive evidence for the use of touchscreen technology in dementia care. The&#xD;
      researchers concluded that touchscreen-based interventions could provide benefits on mood,&#xD;
      mental health, social interaction, quality of interaction, and sense of mastery. If people&#xD;
      with dementia have the appropriate support for the use of touchscreen technology, it is&#xD;
      evidently possible for people to benefit from its use.&#xD;
&#xD;
      A possible way to engage people with dementia with touchscreen technology could be through&#xD;
      the use of the visual arts. Preliminary evidence shows that use of arts for people with&#xD;
      dementia appears to be beneficial in reducing behavioural symptoms, depression and isolation&#xD;
      and make people with dementia more able to express feelings. The use of visual art activities&#xD;
      in touchscreen technology is a promising idea, as positive results from interventions using&#xD;
      these activities separately can be found in scientific literature. So far, very little&#xD;
      research on the benefits of visual art interventions on touchscreen devices has been made.&#xD;
      Thus, there is a need to have more research on this topic. This study will add to research on&#xD;
      this field and its results could be valuable to care staff and people with dementia.&#xD;
      Providing people with dementia a set of exciting activities which have the potential to&#xD;
      enrich people lives and be beneficial for wellbeing.&#xD;
&#xD;
      DESIGN AND METHODOLOGY:&#xD;
&#xD;
      The intervention activity will consist of the use of two different visual art apps on&#xD;
      touchscreen tablets with people with mild to moderate dementia that lives in care homes. The&#xD;
      study will take place in a nursing home in Nottinghamshire. It will involve 12 residents of&#xD;
      the care home with dementia and staff members that are involved in participants' care.&#xD;
      Potential participants will be identified by the care home staff, and staff members will&#xD;
      indicate these people to the research team. Study data collection will take 8 weeks; four&#xD;
      weeks will involve the execution of the intervention and four weeks for additional&#xD;
      measurements (collect consent, screening and end measures). Given the nature of the&#xD;
      intervention, no practical control condition would be a reasonable comparison for this&#xD;
      intervention. Thus, the use of a cross-over design is a suitable control condition to be used&#xD;
      in this study. Participants will be split into two groups of 6 participants; each group will&#xD;
      use one app for two weeks and then change to the other app for another 2 weeks. Participants&#xD;
      will be supported to use the app twice a week, with a maximum of 8 individual sessions over&#xD;
      the four weeks. The data collection will consist of the observation of the activity and on&#xD;
      the use of dementia-specific instruments and questionnaires.&#xD;
&#xD;
      This research aims to explore the supported use of two digital art apps in a participatory&#xD;
      artistic activity with people living with dementia in residential care. The research team is&#xD;
      interested in checking the efficacy of the activity. The team will also evaluate if art&#xD;
      activities on touchscreen tablets are accepted by participants and carers and if the&#xD;
      intervention is feasible in care settings.&#xD;
&#xD;
      The following research questions were formulated for this study:&#xD;
&#xD;
      What effects do participatory digital art on touchscreen tablets have on people with dementia&#xD;
      in care homes? (impact on participants - efficacy)&#xD;
&#xD;
      How the insertion of the digital art activity is perceived by people with dementia and the&#xD;
      care staff (acceptability of the intervention)&#xD;
&#xD;
      How can digital art apps be implemented in care homes to be delivered by the staff?&#xD;
      (practicality of the intervention).&#xD;
&#xD;
      STUDY PROCESS AND TIMETABLE:&#xD;
&#xD;
      • Week 1 to Week 3:&#xD;
&#xD;
      These weeks will focus on:&#xD;
&#xD;
      Visits to explain the study to participants and consultees (30 minutes). Collection of the&#xD;
      consent of the participants and consultees and answer questions (20 minutes).&#xD;
&#xD;
      Once the informed consent is signed potential participants with dementia will be accessed for&#xD;
      cognition with the Montreal Cognitive Assessment - MoCA to ensure that the potential&#xD;
      participants fit the inclusion criteria and will give the investigators a baseline on&#xD;
      participants' cognition before the intervention (10 minutes).&#xD;
&#xD;
      Once the participants are selected, staff members will be contacted to reply to questions and&#xD;
      questionnaires about the participant with dementia. Staff members will be asked to provide&#xD;
      demographic information about the participants (3 minutes for each participant with&#xD;
      dementia), to answer questions about the care home life (5 minutes), and to answer a&#xD;
      proxy-instrument, the QUALIDEM for each of the participants (5 minutes for each participant&#xD;
      with dementia).&#xD;
&#xD;
      Week 4 to Week 7:&#xD;
&#xD;
      The intervention activities with the participants with dementia will take place during these&#xD;
      four weeks. The intervention will be delivered to the participants with dementia at a quiet&#xD;
      room in the care home by two co-investigators, one will be the facilitator, and the other one&#xD;
      will be the observer. All the sessions will be video recorded and analysed by two independent&#xD;
      co-investigators. The use of video was preferred to observation and note taken as with it is&#xD;
      possible to analyse the interaction between the participant and facilitator with the&#xD;
      touchscreen tablet at the same time. With the analysis of the intervention through videos is&#xD;
      also possible to focus on details that could be missed with observations, as videos give the&#xD;
      opportunity to pause and repeat key points of the interaction for a comprehensive analysis.&#xD;
&#xD;
      The intervention is a 30-minutes of individual sessions, with 10 minutes of app use. The&#xD;
      additional 20 minutes will include the setup of the equipment and preparation of the&#xD;
      participant at the beginning of the session; and questions for the participants at the end.&#xD;
      The sessions will happen in the afternoon four days a week (on weekdays), with 6 participants&#xD;
      per day (one of the groups). Each group will have fixed session days, to make the staff aware&#xD;
      of which participants would have a session on a specific day.&#xD;
&#xD;
      Data collection here will be made through:&#xD;
&#xD;
      Participants' observation: Participants' behaviour in the video records of the sessions will&#xD;
      be analysed with an adapted version of the Greater Cincinnati Chapter Wellbeing Observation&#xD;
      Tool.&#xD;
&#xD;
      Questions to participants: At the end of each session, the participants will be asked to&#xD;
      answer questions on visual analogue scales (VAS) to evaluate participants subjective&#xD;
      wellbeing at that moment (3 minutes).&#xD;
&#xD;
      Questionnaires and questions to staff: Staff members will be asked to answer the QUALIDEM&#xD;
      once a week during the 4-week intervention for each of the participants (5 minutes for each&#xD;
      participant with dementia).&#xD;
&#xD;
      The research team will also evaluate the acceptability and practicality of the intervention:&#xD;
&#xD;
      Acceptability: Participants will be asked at the end of the sessions (once a week) questions&#xD;
      about satisfaction with the apps and the intervention (3 minutes) relevance of the activity,&#xD;
      and if would be interest in continue the use of the apps (VAS, and open questions). The&#xD;
      research team will also check for actual use of the touchscreen tablet between the sessions&#xD;
      and will provide a form to the care staff keep a record (1 minute for each entry).&#xD;
&#xD;
      Practicality: To evaluate the practicality of the intervention, the participants and the&#xD;
      staff will be asked on the opinion on frequency and duration of the intervention (ideal and&#xD;
      what was received) (3 minutes). During the intervention the researchers will make&#xD;
      observations on care home daily life and will collect information on the type and amount of&#xD;
      resources needed, training required and time to support the intervention. There also will be&#xD;
      an analysis of the barriers and facilitators for the implementation of the activity in care&#xD;
      homes. One of the researchers will collect this information through field notes of&#xD;
      observation of the sessions and discussions with the care staff.&#xD;
&#xD;
      Week 8:&#xD;
&#xD;
      For end measurements, the MoCA (10 minutes) will be used with participants with dementia and&#xD;
      the staff members will be asked to answer the QUALIDEM for each of the participants (5&#xD;
      minutes for each participant with dementia).&#xD;
&#xD;
      • At a later point (data collection finished): Once data collection is complete, the research&#xD;
      team will develop the guidance on the use of touchscreen tablets in residential care for&#xD;
      people with dementia. Staff members from the care home will be asked to give feedback on the&#xD;
      guidance through informal consultation. This informal consultation could happen through email&#xD;
      communication or in-person meetings. This should happen within 2 months after the end of data&#xD;
      collection. The analysis and writing up findings should take up to 5 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Anticipated">April 12, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on Wellbeing</measure>
    <time_frame>1 month</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Mild Dementia</condition>
  <condition>Moderate Dementia</condition>
  <arm_group>
    <arm_group_label>Art apps - Group 1 (A-B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross-over use of two different visual art apps on touchscreen tablets (App A and App B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Art apps - Group 2 (B-A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross-over use of two different visual art apps on touchscreen tablets (App B and App A)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Art apps</intervention_name>
    <description>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.</description>
    <arm_group_label>Art apps - Group 1 (A-B)</arm_group_label>
    <arm_group_label>Art apps - Group 2 (B-A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants with dementia:&#xD;
&#xD;
          -  To be living in a Care Home in Nottinghamshire;&#xD;
&#xD;
          -  To have mild dementia [21 to 26 points in the Mini-Mental State Examination (MMSE) or&#xD;
             a comparable score on the MoCA from 16 to 20 points] or moderate dementia [10 to 20&#xD;
             points on the MMSE or a comparable score on the MoCA from 2 to 15 points];&#xD;
&#xD;
          -  To be willing to use apps on touchscreen tablets;&#xD;
&#xD;
          -  Ability to give informed consent or have a consultee that provides advice;&#xD;
&#xD;
          -  Ability to speak and understand English.&#xD;
&#xD;
        Nursing home staff:&#xD;
&#xD;
          -  To be involved in the care of at least one of the participants;&#xD;
&#xD;
          -  Ability to speak and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants with dementia:&#xD;
&#xD;
          -  To have conditions that could limit hand-control (e.g. stroke, Parkinson's disease);&#xD;
&#xD;
          -  To have severe visual or hearing impairments;&#xD;
&#xD;
          -  Simultaneous participation in any other interventional study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26897552</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17612800</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18602707</PMID>
  </reference>
  <reference>
    <citation>Dichter, M., Ettema, T., Schwab, C., Meyer, G., Bartholomeyczik, S., Halek, M., &amp; Dröes, R. (2016). QUALIDEM-user guide. DZNE/VUmc, Witten/Amsterdam.</citation>
  </reference>
  <reference>
    <citation>Folstein MF, Folstein SE, McHugh PR. &quot;Mini-mental state&quot;. 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.</citation>
    <PMID>1202204</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24339088</PMID>
  </reference>
  <reference>
    <citation>Han, A., Radel, J., McDowd, J. M., &amp; Sabata, D. (2016). The Benefits of Individualized Leisure and Social Activity Interventions for People with Dementia: A Systematic Review. Activities, Adaptation &amp; Aging, 40(3), 219-265. doi:10.1080/01924788.2016.1199516</citation>
  </reference>
  <reference>
    <citation>Hannemann BT. Creativity with dementia patients. Can creativity and art stimulate dementia patients positively? Gerontology. 2006;52(1):59-65. doi: 10.1159/000089827.</citation>
    <PMID>16439826</PMID>
  </reference>
  <reference>
    <citation>Joddrell, P. (2017). Investigating the potential of touchscreen technology to create opportunities for independent activity with people living with dementia. University of Sheffield.</citation>
  </reference>
  <reference>
    <citation>Joddrell, P., Hernandez, A., &amp; 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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16136845</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24339097</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23923689</PMID>
  </reference>
  <reference>
    <citation>Mihailidis, A., Blunsden, S., Boger, J., Richards, B., Zutis, K., Young, L., &amp; 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.</citation>
  </reference>
  <reference>
    <citation>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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
    <PMID>15817019</PMID>
  </reference>
  <reference>
    <citation>NICE. (2011). Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease. Retrieved from https://www.nice.org.uk/guidance/ta217</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26346644</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28446258</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26675353</PMID>
  </reference>
  <reference>
    <citation>Upton, D., Upton, P., Jones, T., Jutlla, K., Brooker, D., &amp; 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.</citation>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>care home</keyword>
  <keyword>visual art</keyword>
  <keyword>app</keyword>
  <keyword>touchscreen technology</keyword>
  <keyword>dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773016
org study id: 18080
nct id: NCT03773016
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
SCIENTIFIC JUSTIFICATION:

      People with dementia that live in care homes are more prone to experience a lack of
      stimulation and be socially isolated. Activities that are likely to be beneficial for people
      with dementia are social and leisure activities, as the activities promote engagement and
      improve affect. It has been argued that these activities should be of high importance in care
      settings and that care home residents living with dementia should have access to meaningful
      activities and are supported when engaging with the activities.

      The use of touchscreen technology is one strategy that may possibly engage older people in
      enjoyable leisure activities. In past research, people with dementia and staff reported
      positive experiences with the use of technology in previous research that evaluate the
      impacts of touchscreen technology in care homes. This same research also showed supportive
      evidence for the positive contribution of the touchscreen technology for improvements in
      quality of life, relationships and interpersonal interactions. A literature review from 2017
      on the use of touchscreen technology by people with dementia and its impact on wellbeing also
      shows supportive evidence for the use of touchscreen technology in dementia care. The
      researchers concluded that touchscreen-based interventions could provide benefits on mood,
      mental health, social interaction, quality of interaction, and sense of mastery. If people
      with dementia have the appropriate support for the use of touchscreen technology, it is
      evidently possible for people to benefit from its use.

      A possible way to engage people with dementia with touchscreen technology could be through
      the use of the visual arts. Preliminary evidence shows that use of arts for people with
      dementia appears 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 separately can be found in scientific literature. 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.
      Providing people with dementia a set of exciting activities which have the potential to
      enrich people lives and be beneficial for wellbeing.

      DESIGN AND METHODOLOGY:

      The intervention activity will consist of the use of two different visual art apps on
      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. It will involve 12 residents of
      the care home with dementia and staff members that are involved in participants' care.
      Potential participants will be identified by the care home staff, and staff members will
      indicate these people to the research team. 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). Given the nature of the
      intervention, no practical control condition would be a reasonable comparison for this
      intervention. Thus, the use of a cross-over design is a suitable control condition to be used
      in this study. 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.

      This research aims to explore the supported use of two digital art apps in a participatory
      artistic activity with people living with dementia in residential care. The research team is
      interested in checking the efficacy of the activity. The team will also evaluate if art
      activities on touchscreen tablets are accepted by participants and carers and if the
      intervention is feasible in care settings.

      The following research questions were formulated for this study:

      What effects do participatory digital art on touchscreen tablets have on people with dementia
      in care homes? (impact on participants - efficacy)

      How the insertion of the digital art activity is perceived by people with dementia and the
      care staff (acceptability of the intervention)

      How can digital art apps be implemented in care homes to be delivered by the staff?
      (practicality of the intervention).

      STUDY PROCESS AND TIMETABLE:

      • Week 1 to Week 3:

      These weeks will focus on:

      Visits to explain the study to participants and consultees (30 minutes). Collection of the
      consent of the participants and consultees and answer questions (20 minutes).

      Once the informed consent is signed potential participants with dementia will be accessed for
      cognition with the Montreal Cognitive Assessment - MoCA to ensure that the potential
      participants fit the inclusion criteria and will give the investigators a baseline on
      participants' cognition before the intervention (10 minutes).

      Once the participants are selected, staff members will be contacted to reply to questions and
      questionnaires about the participant with dementia. Staff members will be asked to provide
      demographic information about the participants (3 minutes for each participant with
      dementia), to answer questions about the care home life (5 minutes), and to answer a
      proxy-instrument, the QUALIDEM for each of the participants (5 minutes for each participant
      with dementia).

      Week 4 to Week 7:

      The intervention activities with the participants with dementia will take place during these
      four weeks. The intervention will be delivered to the participants with dementia 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. All the sessions will be video recorded and analysed by two independent
      co-investigators. The use of video was preferred to observation and note taken as with it is
      possible to analyse the interaction between the participant and facilitator with the
      touchscreen tablet at the same time. With the analysis of the intervention through videos is
      also possible to focus on details that could be missed with observations, as videos give the
      opportunity to pause and repeat key points of the interaction for a comprehensive analysis.

      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.
      The sessions will happen in the afternoon four days a week (on weekdays), with 6 participants
      per day (one of the groups). Each group will have fixed session days, to make the staff aware
      of which participants would have a session on a specific day.

      Data collection here will be made through:

      Participants' observation: Participants' behaviour in the video records of the sessions will
      be analysed with an adapted version of the Greater Cincinnati Chapter Wellbeing Observation
      Tool.

      Questions to participants: At the end of each session, the participants will be asked to
      answer questions on visual analogue scales (VAS) to evaluate participants subjective
      wellbeing at that moment (3 minutes).

      Questionnaires and questions to staff: Staff members will be asked to answer the QUALIDEM
      once a week during the 4-week intervention for each of the participants (5 minutes for each
      participant with dementia).

      The research team will also evaluate the acceptability and practicality of the intervention:

      Acceptability: Participants will be asked at the end of the sessions (once a week) questions
      about satisfaction with the apps and the intervention (3 minutes) relevance of the activity,
      and if would be interest in continue the use of the apps (VAS, and open questions). The
      research team will also check for actual use of the touchscreen tablet between the sessions
      and will provide a form to the care staff keep a record (1 minute for each entry).

      Practicality: To evaluate the practicality of the intervention, the participants and the
      staff will be asked on the opinion on frequency and duration of the intervention (ideal and
      what was received) (3 minutes). During the intervention the researchers will make
      observations on care home daily life and will collect information on the type and amount of
      resources needed, training required and time to support the intervention. There also will be
      an analysis of the barriers and facilitators for the implementation of the activity in care
      homes. One of the researchers will collect this information through field notes of
      observation of the sessions and discussions with the care staff.

      Week 8:

      For end measurements, the MoCA (10 minutes) will be used with participants with dementia and
      the staff members will be asked to answer the QUALIDEM for each of the participants (5
      minutes for each participant with dementia).

      • At a later point (data collection finished): Once data collection is complete, the research
      team will develop the guidance on the use of touchscreen tablets in residential care for
      people with dementia. Staff members from the care home will be asked to give feedback on the
      guidance through informal consultation. This informal consultation could happen through email
      communication or in-person meetings. This should happen within 2 months after the end of data
      collection. The analysis and writing up findings should take up to 5 months.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: 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.
primary purpose: Other
masking: None (Open Label)
measure: Change on Wellbeing
time frame: 1 month
description: 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).
arm group label: Art apps - Group 1 (A-B)
arm group type: Experimental
description: Cross-over use of two different visual art apps on touchscreen tablets (App A and App B)
arm group label: Art apps - Group 2 (B-A)
arm group type: Experimental
description: Cross-over use of two different visual art apps on touchscreen tablets (App B and App A)
intervention type: Behavioral
intervention name: Art apps
description: 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.
arm group label: Art apps - Group 1 (A-B)
arm group label: Art apps - Group 2 (B-A)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
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responsible party type: Sponsor
mesh term: Dementia
mesh term: Alzheimer Disease
sharing ipd: No