NCT04797533

Brief Summary

Monitoring of Biologic Signals of Elderly Patients

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
terminated

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 14, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

February 25, 2021

Last Update Submit

March 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Testing the Suitability of the Bed Sensor in Clinical Settings and Evaluating the Accuracy of the Breathing Rate Monitoring of the BIMS Device

    2 Years

Secondary Outcomes (2)

  • The Weekly Change in the Hospital Anxiety and Depression Scale (HADS) Score

    Once weekly throughout patient stay in ward up to a maximum of 2 years.

  • The Weekly Change in the Pittsburgh Sleep Quality Index (PSQI) Score

    Once weekly throughout patient stay in ward up to a maximum of 2 years.

Interventions

The Body Information Management Systems (BIMS) are advanced biological sensors which monitor human behaviour, activity and basic vital signs. There is a combination of four separate ultra-sensitive weighing scales attached to each of the individual legs of a hospital bed measuring: * Micro-changes in weight distribution * Activity/sleep pattern In addition to the bed-based system, there will be a wrist worn wearable (Samsung fit gear) that will monitor participants when they are both in and out of bed. These are about the size of a small watch, light weight, water resistant, and will be worn 24/7 by participants. These measure: * Movement and sleep * Heart rate

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For service users:
  • Female
  • In-patient on Spencer Ward, Abraham Cowley Unit, SABP.
  • Presenting with any psychiatric illness
  • Willing to provide informed consent
  • For participants assessed to lack capacity, a consultee must advise if they believe the individual would provide consent or not
  • For staff:
  • Male or Female
  • Staff working on Spencer Ward, Abraham Cowley Unit, SABP.
  • Willing to provide informed consent
  • years of age or over
  • For Carers:
  • Male or female
  • Carer, family member or friend of service user on Spencer Ward
  • Willing to provide informed consent
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spenser Ward, Abraham Cowley Unit

Chertsey, Surrey, KT16 0AE, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: To determine whether the contactless body monitoring service can provide objective data to improve staff workload and service user experience. Additionally, the project will explore how the data from the devices can be combined and viewed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 15, 2021

Study Start

June 14, 2019

Primary Completion

September 22, 2020

Study Completion

October 15, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations