NCT04752306

Brief Summary

The aim of the study is to explore the criteria and conditions for the integration of sensor technology in disposable pads according to the needs and opinions of residents with incontinence, healthcare workers, and policymakers in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

June 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
Last Updated

February 12, 2021

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 13, 2020

Last Update Submit

February 11, 2021

Conditions

Keywords

incontinencepadssensor technology

Outcome Measures

Primary Outcomes (1)

  • requirements for sensor technology in disposable bodyworns measured with a semi-structured questionnaire

    To successfully implement sensor technology; requirements for the sensor technology must be defined according to the relevant stakeholder groups. Throughout the development process the researcher will question nursing home residents, healthcare workers and policymakers in semi-structured interviews to identify how the sensor technology could improve the quality of care, and reduce workload and costs.

    6 months

Study Arms (3)

residents

10 residents * Minimum 1x \> 1week had experience with incontinence material * MMSE score \>23 * good verbal communication

Other: Interviews

healthcare workers

8 healthcare workers working in setting, no exclusion criteria

Other: Interviews

policymakers

2 policymakers responsible for the purchase of incontinence material

Other: Interviews

Interventions

Semi-structured interviews will take place between June and August 2020. Eight individual interviews with healthcare workers, ten individual interviews with residents and two individual interviews with policymakers. Interviews with the healthcare workers and policymakers will take place in a meeting room at the nursing home of employment. One interview with a policymaker will take place online. Interviews with residents will be hold in their personal room.

healthcare workerspolicymakersresidents

Eligibility Criteria

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

10 residents, 8 healthcare workers and 2 policymakers from 3 nursinghomes in Flandres (Belgium)

You may qualify if:

  • Residents
  • if they have worn absorbent incontinence products minimum one time for more than one week
  • if they have a Mini-Mental State Examination (MMSE)-score of \>23
  • if they are able to communicate verbally
  • Health care workers
  • if they are health care assistants or nurses
  • Policymakers if they have a role in the financial decisions regarding incontinence material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Residentie Vroonstalle

Ghent, Oost-vlaanderen, 9000, Belgium

Location

Rustenhove

Ledegem, West-Vlaanderen, 8880, Belgium

Location

Residentie Brugse Vaart

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Raepsaet C, Serraes B, Verhaeghe S, Beeckman D. Integrating Sensor Technology in Disposable Body-Worn Absorbent Products: A Qualitative Study to Define User Profile, (Technical) Criteria, Conditions, and Potential Benefits. J Wound Ostomy Continence Nurs. 2021 Nov-Dec 01;48(6):560-567. doi: 10.1097/WON.0000000000000812.

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

October 13, 2020

First Posted

February 12, 2021

Study Start

June 15, 2020

Primary Completion

September 25, 2020

Study Completion

September 30, 2020

Last Updated

February 12, 2021

Record last verified: 2020-10

Locations