- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752306
The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes
February 11, 2021 updated by: University Ghent
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Gent, Belgium, 9000
- Residentie Brugse Vaart
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Oost-vlaanderen
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Gent, Oost-vlaanderen, Belgium, 9000
- Residentie Vroonstalle
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West-Vlaanderen
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Ledegem, West-Vlaanderen, Belgium, 8880
- Rustenhove
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
10 residents, 8 healthcare workers and 2 policymakers from 3 nursinghomes in Flandres (Belgium)
Description
Inclusion Criteria:
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.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
residents
10 residents
|
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 workers
8 healthcare workers working in setting, no exclusion criteria
|
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.
|
|
policymakers
2 policymakers responsible for the purchase of incontinence material
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
requirements for sensor technology in disposable bodyworns measured with a semi-structured questionnaire
Time Frame: 6 months
|
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.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2020
Primary Completion (Actual)
September 25, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
February 11, 2021
First Posted (Actual)
February 12, 2021
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 11, 2021
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BC-07270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Data will be available upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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