NCT04884711

Brief Summary

One of the crucial components of successful ageing is to live independently in old age. Yet in UK alone, nearly 300000 older people require assistance with 3 or more essential daily tasks like eating, bathing and mobility which compromises on their independent living. Additionally, in a crisis where health system in UK is already overstretched to its resources to combat the recent Coronavirus Disease 2019 (COVID-19) pandemic, allocating resources for regular homecare services has become challenging. In this situation, Digital Health Technologies (DHTs) can be a potential solution to promote healthy ageing, support psycho-social wellbeing and enhance independent living for older people. Such technologies comprise a wide range of products used in the health and care services including apps, software and online platforms to benefit people. Yet DHTs are barely adopted by older people as they do not reflect their actual user needs leading to poor appropriation of DHTs in homecare settings. The investigators aim to address this gap by involving older people living at the Leach Court, UK under the eco system of the Brighton \& Hove Digital Health Living Lab (BHLL) to co-design with us DHTs that addresses the barriers \& facilitators they face in adopting to DHTs. This participatory research approach has a qualitative study design which is sensitive to basic human values like 'dignity', appreciates that older people are 'expert of their experiences' and methodologically has phenomenological underpinnings gathering the researcher's understanding from the lived experiences of older people. This unique project, part of the European Union (EU) Horizon 2020 funded INNOVATEDIGNITY project, will be aiming to translate intangible human values like 'dignity' into tangible technology design through better understanding of the barriers \& facilitators older people face to DHTs adoption. With global population of older people increasing faster than all other age groups currently, this project stands to meet the future demands of the ageing population through dignity sensitive better designed DHTs . This project is part of the Marie Skłodowska-Curie Actions (MSCA) Innovative Training Networks (ITN). This project has received funding from the European Union's H2020-MSCA-ITN-2018 programme under grant agreement No 813928.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

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 20, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

November 20, 2020

Last Update Submit

May 12, 2021

Conditions

Keywords

geriatricswearable electronic devicesself-help devicesbiomedical technologydisruptive technologyHealthy Ageingagedhomes for the agedHuman Centered DesignDigital Technology

Outcome Measures

Primary Outcomes (2)

  • Participants Lived Experience with Digital Health Technologies

    Participants will be asked open ended questions about their everyday experience with Digital Health Technologies. Interviews will be transcribed verbatim and analysed to identify the barriers \& facilitators to Digital Health Technologies.

    7 months

  • Strategies to enhance dignity and address barriers to Digital Health Technology adoption

    Focus group discussions will be held with 5 participants in each group lasting around 3 hours per focus group discussion to strategise solutions to digital health technology adoption for older people.

    1 day

Study Arms (2)

Interviews: Older people living at the Leach Court (Brighton, UK).

Older adults who will be enrolled at the Leach Court (Brighton, UK) as a part of the INNOVATEDIGNITY project will be involved in 1:1 open ended interviews.

Other: No Interventions. Participants will be using their everyday digital health technologies.Other: In depth Interviews

Focus Group Discussions: Older People Living at the Leach Court (Brighton, UK)

10 older people who have previously participated in the interview stage will be involved in two focus group discussions in a group of 5 participants each to co-design digital health technologies that are 'dignity' sensitive and aims to resolve the barriers older people face in technology adoption.

Other: Focus Group Discussions

Interventions

The investigators will be involving older people to understand the barriers \& facilitators of digital health technology adoption for homebound older people. In this process no interventions will be given by us.

Interviews: Older people living at the Leach Court (Brighton, UK).

In-depth interviews will be conducted to gather lived experiences of homebound older people.

Interviews: Older people living at the Leach Court (Brighton, UK).

Focus Group Discussions will be used to create avenues to enhance dignity and human perspectives in digital designs for older people.

Focus Group Discussions: Older People Living at the Leach Court (Brighton, UK)

Eligibility Criteria

Age65 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe investigators will welcome an inclusive approach to technology design by involving people from all gender based on their self-identification.
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older adults meeting the inclusion criteria and living in the Leach Court (Brighton, UK). There will be 10 older participants in this study and if many more people volunteers, the investigators will invite a maximum of 20 participants. Participants will be selected based on age range, gender, existing disabilities, and exposure to digital health technologies. The research plans for at least 2 participants per chronologically advancing age group inter spaced at a 5 years interval starting from 65- 70 years \& ending at 85-90 years. The participants will be gradually recruited as responses arrive with the research investigator. The study group is vulnerable especially in the light of current COVID 19 crisis with multiple underlying co-morbid conditions.

You may qualify if:

  • Age should be at least 65 years.
  • Participants who are able to read \& write in English.
  • Older people living in the Leach Court (Brighton, UK) for at least the past one year.
  • Participants of all gender will be entertained.

You may not qualify if:

  • People who are unable to communicate in english.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leach Court

Brighton, East Sussex, BN20DJ, United Kingdom

Location

Related Publications (25)

  • Raleigh VS. Stalling life expectancy in the UK. BMJ. 2018 Sep 27;362:k4050. doi: 10.1136/bmj.k4050. No abstract available.

    PMID: 30262572BACKGROUND
  • Cecula P, Behan SD, Maruthappu M. COVID-19: Challenges and opportunities in the care sector. EClinicalMedicine. 2020 May 11;23:100390. doi: 10.1016/j.eclinm.2020.100390. eCollection 2020 Jun. No abstract available.

    PMID: 32395708BACKGROUND
  • Lawton MP. Competence, environmental press, and the adaptation of older people. In: Lawton MP, Windley PG, Byerts TO, editors. Aging and the environment: Theoretical approaches. New York: Springer. 1982.pp. 33-59.

    BACKGROUND
  • Wilkinson C. Evaluating the role of prior experience in inclusive design. Engineering Department. University of Cambridge.2011.

    BACKGROUND
  • Sleeswijk V.F., Stappers, P.J., van der Lugt, R., and Sanders, E.B.N. Contextmapping: experiences from practice. CoDesign.2005. 1 (2), 119-149. DOI: 10.1080/15710880500135987

    BACKGROUND
  • Hahn J. Structure of a Dissertation for a Participatory Phenomenology Design. In: Strang K.D. (eds) The Palgrave Handbook of Research Design in Business and Management. 2015.Palgrave Macmillan, New York.

    BACKGROUND
  • Stoecker R.Three crucial turns on the road to an adequate understanding of human dignity. In Humiliation, degradation, dehumanization. 2011; pp. 7-17. Springer, Dordrecht.

    BACKGROUND
  • National Institute for Health and Care Excellence. Evidence standards framework for digital health technologies.2019. https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/evidence-standards-framework/user-guide.pdf

    BACKGROUND
  • University of Brighton. Brighton and Hove Digital Health Living Lab. 2018.Retrieved September 28, 2020, from https://www.brighton.ac.uk/research-and-enterprise/enterprise/enterprise-projects/brighton-and-hove-digital-health-living-lab.aspx

    BACKGROUND
  • United Nations. Ageing. 2019.Retrieved September 28, 2020, from https://www.un.org/en/sections/issues-depth/ageing/

    BACKGROUND
  • Wang S, Bolling K, Mao W, Reichstadt J, Jeste D, Kim HC, Nebeker C. Technology to Support Aging in Place: Older Adults' Perspectives. Healthcare (Basel). 2019 Apr 10;7(2):60. doi: 10.3390/healthcare7020060.

    PMID: 30974780BACKGROUND
  • Scandurra I, Sjolinder M. Participatory Design With Seniors: Design of Future Services and Iterative Refinements of Interactive eHealth Services for Old Citizens. Med 2 0. 2013 Oct 8;2(2):e12. doi: 10.2196/med20.2729. eCollection 2013 Jul-Dec.

    PMID: 25075235BACKGROUND
  • Renaud, K.; Karen, B.J. Judy Predicting technology acceptance and adoption by the elderly: A qualitative study. In Proceedings of the ACM International Conference Proceeding Series, Wilderness, South Africa, 6-8 October 2008; Volume 338.

    BACKGROUND
  • Peek ST, Wouters EJ, Luijkx KG, Vrijhoef HJ. What it Takes to Successfully Implement Technology for Aging in Place: Focus Groups With Stakeholders. J Med Internet Res. 2016 May 3;18(5):e98. doi: 10.2196/jmir.5253.

    PMID: 27143097BACKGROUND
  • Chiu, C.-J.; Hu, Y.-H.; Lin, D.-C.; Chang, F.-Y.; Chang, C.-S.; Lai, C.-F. The attitudes, impact, and learning needs of older adults using apps on touchscreen mobile devices: Results from a pilot study. Computer Human Behaviour 2016, 63,189-197.

    BACKGROUND
  • Helal S, Mann W, El-Zabadani, King J, Kaddoura J, Jansen E. The gator tech smart house: a programmable pervasive space. Computer in Computer 2005;38(3):50-60.

    BACKGROUND
  • Sanders, E. B.-N., Generative Tools for CoDesigning in Scrivener, Ball and Woodcock, eds. Collaborative Design (London Limited: Springer-Verlag, 2000).

    BACKGROUND
  • Conboy-Hill, Informed Consent & Virtual Worlds, 2009. Available Online: https://www.economist.com/node/13899038

    BACKGROUND
  • Usher KJ, Arthur D. Process consent: a model for enhancing informed consent in mental health nursing. J Adv Nurs. 1998 Apr;27(4):692-7. doi: 10.1046/j.1365-2648.1998.00589.x.

    PMID: 9578197BACKGROUND
  • Wherton J, Sugarhood P, Procter R, Rouncefield M, Dewsbury G, Hinder S, Greenhalgh T. Designing assisted living technologies 'in the wild': preliminary experiences with cultural probe methodology. BMC Med Res Methodol. 2012 Dec 20;12:188. doi: 10.1186/1471-2288-12-188.

    PMID: 23256612BACKGROUND
  • Dahlberg, K., Dahlberg, H., & Nyström, M. Reflective lifeworld research (2nd ed.). 2008 Lund: Studentlitteratur.

    BACKGROUND
  • Personal Data Protection Commission, Guide to Basic Data Anonymisation Techniques. Singapore: 2018. Available Online: https://www.pdpc.gov.sg/-/media/Files/PDPC/PDF-Files/Other-Guides/Guide-to-Anonymisation_v1-(250118).pdf

    BACKGROUND
  • El Emam K. Guide to the De-Identification of Personal Health Information. CRC Press, 2013.

    BACKGROUND
  • European Commission (EC). Open Research Data and Data Management Plans. Brussels: ERC Scientific Council 2019. Available Online: https://erc.europa.eu/sites/default/files/document/file/ERC_info_document-Open_Research_Data_and_Data_Management_Plans.pdf

    BACKGROUND
  • Ramos MC. Some ethical implications of qualitative research. Res Nurs Health. 1989 Feb;12(1):57-63. doi: 10.1002/nur.4770120109.

    PMID: 2922491BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Prof.Kathleen Galvin, PhD

    University of Brighton

    PRINCIPAL INVESTIGATOR
  • Dr. Theofanis Fotis, PhD

    University of Brighton

    PRINCIPAL INVESTIGATOR
  • Prof.Lisbeth Uhrendfeldt, PhD

    Nord University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuvarthi Bhattacharjee, M.Sc.

CONTACT

Prof.Kathleen Galvin, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing Practice

Study Record Dates

First Submitted

November 20, 2020

First Posted

May 13, 2021

Study Start

July 30, 2021

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

May 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

The investigators will follow guidelines of the European Commission on General Data Protection Regulation (GDPR), data management plan of the INNOVATEDIGNITY project and guidelines of the University of Brighton to make sure that privacy and confidentiality of the participants are retained while sharing Individual Patient Data (IPD).

Shared Documents
STUDY PROTOCOL
Time Frame
Anonymised and relabelled IPD will be available at the earliest at least 1 year post publication of study results in scientific journals.
Access Criteria
Anonymised \& relabelled data will be converted into metadata format by the UK Open Access Data Archive which can be accessed by other researchers for secondary analysis.
More information

Locations