IncontinenceNCT04752306
The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes
An observational study of Incontinence, run by University Ghent at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Interviews
- How many people
- 20 participants
- Where
- 3 sitesBelgium
- Study dates
- 15 Jun 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 residents, 8 healthcare workers and 2 policymakers from 3 nursinghomes in Flandres (Belgium)
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Residentie Vroonstalle
Ghent, Oost-vlaanderen, 9000
Residentie Brugse Vaart
Ghent, 9000
Rustenhove
Ledegem, West-Vlaanderen, 8880
About this study
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.
- Conditions
- Incontinence
- Being tested
- Interviews
- Keywords
- incontinence, pads, sensor technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| residents | 10 residents
* Minimum 1x > 1week had experience with incontinence material
* MMSE score >23
* good verbal communication Receives: Other: Interviews | |
| healthcare workers | 8 healthcare workers working in setting, no exclusion criteria Receives: Other: Interviews | |
| policymakers | 2 policymakers responsible for the purchase of incontinence material Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start15 Jun 2020
- Primary completion25 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752306
- Sponsor's protocol ID
- BC-07270
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available upon request
Publications
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.
PubMed 34781313
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes
- ClinicalTrials.gov ID
- NCT04752306
- Acronym / sponsor ID
- BC-07270
- Conditions
- Incontinence
- Keywords
- incontinence, pads, sensor technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| residents | – | Other: Interviews10 residents * Minimum 1x > 1week had experience with incontinence material * MMSE score >23 * good verbal communication |
| healthcare workers | – | Other: Interviews8 healthcare workers working in setting, no exclusion criteria |
| policymakers | – | Other: Interviews2 policymakers responsible for the purchase of incontinence material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 residents, 8 healthcare workers and 2 policymakers from 3 nursinghomes in Flandres (Belgium)
Key inclusion criteria (7 listed)
- Residents
- Health care workers
- if they are health care assistants or nurses
- Policymakers if they have a role in the financial decisions regarding incontinence material.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsSemi-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. | Other | healthcare workers, policymakers, residents |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 34781313Raepsaet 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.
- Individual participant dataSharing planned: Undecided. Data will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incontinence, run by University Ghent at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
requirements for sensor technology in disposable bodyworns measured with a semi-structured questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.