NCT05439304

Brief Summary

This study primary objective of this study is to identify promoting and hindering factors that affect the implementation of a smart robot in a care home setting.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

June 14, 2022

Last Update Submit

June 27, 2022

Conditions

Dementia

Keywords

Care homeTechnologyPerson centred care

Outcome Measures

Primary Outcomes (1)

  • Hindering and promoting factors to technology implementation

    Measured using qualitative interviews with care staff, residents and family members and observation of residents and family members

    Three years

Secondary Outcomes (3)

  • Implementation and use of technology in a care home setting

    July - December 2022

  • User perspective on Berntsen

    January - June 2023

  • People with dementia and family member communication through Berntsen

    July - December 2023

Study Arms (3)

Care staff

Other: No intervention

Residents

Other: No intervention

Family members

Other: No intervention

Interventions

No interventionOTHER

No intervention

Care staffFamily membersResidents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be recruited from two care homes also included in the cluster RCT. For diversity purposes, we seek to include both large and smaller care homes from larger cities and rural areas and purposely include two different units from each care to reflect the variety of experiences.

You may not qualify if:

  • Any participants who are not able to give informed consent themselves or through a consultee will not be included in the project.
  • Family member
  • All family members of included residents will be invited to participate in the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.

    PMID: 29408901BACKGROUND

  • Barbosa Neves B, Sanders A, Kokanovic R. "It's the worst bloody feeling in the world": Experiences of loneliness and social isolation among older people living in care homes. J Aging Stud. 2019 Jun;49:74-84. doi: 10.1016/j.jaging.2019.100785. Epub 2019 Jun 6.

    PMID: 31229221BACKGROUND

  • Ko M, Wagner L, Spetz J. Nursing Home Implementation of Health Information Technology: Review of the Literature Finds Inadequate Investment in Preparation, Infrastructure, and Training. Inquiry. 2018 Jan-Dec;55:46958018778902. doi: 10.1177/0046958018778902.

    PMID: 29888677BACKGROUND

  • Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: A systematic literature review. Int J Med Inform. 2016 Jan;85(1):17-26. doi: 10.1016/j.ijmedinf.2015.05.014. Epub 2015 Jun 11.

    PMID: 26216463BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Lise Birgitte Holteng

CONTACT

0047 40063238lise.birgitte.austbo.holteng@sus.no

Ingelin Testad, PhD

CONTACT

0047 95797079ingelin.testad@sus.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 30, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

June 30, 2022

Record last verified: 2022-06