NCT02603380

Brief Summary

This qualitative study aims to evaluate the usability of a smartphone application called DelApp. The study will assess usability and acceptability of the software app by asking 40 clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback will be collected through semi-structured interviews with the clinicians. The feedback will be used to optimise the software application in preparation for formal validations studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
completed

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

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

October 19, 2015

Last Update Submit

November 9, 2015

Conditions

Keywords

DeliriumFeasibility studysoftware applicationqualitative

Outcome Measures

Primary Outcomes (1)

  • Semi-structured interviews with clinicians and patients to produce a set of recommendations to refine and optimise the DelApp.

    Clinicians and patients who have used the DelApp will be interviewed using semi structured interviews.

    Baseline

Secondary Outcomes (1)

  • System usability scale to measure the usability of the DelApp.

    Baseline

Study Arms (2)

Clinical staff

Clinicians in the Royal Infirmary of Edinburgh.

Other: No intervention

Patients

Patients in intensive care units and general wards in the Royal Infirmary of Edinburgh.

Other: No intervention

Interventions

This is an observational study. No intervention will be given.

Clinical staffPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Royal Infirmary of Edinburgh (RIE) general wards and intensive care units.

You may qualify if:

  • Native or fluent English speaker
  • Capacity to give consent to participate in the study
  • Aged 65 or over

You may not qualify if:

  • Vision, hearing or speech impairment severe enough to preclude testing and interview.
  • Known or suspected cognitive impairment including dementia
  • Photosensitive epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • David J Stott

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Elizabeth Wilson

    NHS Lothian

    PRINCIPAL INVESTIGATOR
  • Timothy Walsh

    University of Edinburgh

    PRINCIPAL INVESTIGATOR
  • Tara Quasim

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Jonathan Evans

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Christopher Weir

    University of Edinburgh

    PRINCIPAL INVESTIGATOR
  • Alexander Weir

    Medical Devices Unit

    PRINCIPAL INVESTIGATOR
  • Stuart Parks

    Medical Devices Unit

    PRINCIPAL INVESTIGATOR
  • Jenny Barnett

    Cambridge Cognition Ltd

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

November 11, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 11, 2015

Record last verified: 2015-11