Urinary IncontinenceARCTICCNCT02511314
A Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
A study testing TENA Identifi in people with Urinary Incontinence, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to compare the use of an electronic incontinence identification system with nursing home support (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older residents of nursing care homes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- TENA Identifi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2018to 30 Mar 2020
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Nursing homes: A facility which:
- provides care for residents over the age of 65 years
- has an existing policy for continence care
- is registered with the appropriate Provincial authorities
- engages in recording of the RAI- MDS v2.0
- Residents: Nursing home residents over the age of 65 requiring a continence assessment upon entry to the nursing home or requiring a reassessment because of either a change in clinical status or provincial requirement shall be eligible for entry
Who cannot join
- Residents
- at the end of life,
- with profound behavioural disturbances likely to render the use of the Tena Identifi system impractical
- an identifiable, potentially reversible cause for their urinary incontinence (e.g.: acute urinary tract infection)
- with double incontinence dominated by faecal incontinence
- Staff and Managers - Staff who did not take the training on the Identifi system or managers whose units that did not participate in the study will be ineligible for the focus group.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, T6G 2P4
About this study
Official title: A Randomised, Controlled Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
The purpose of this study is to compare the use of an electronic incontinence identification system with nursing home support (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older residents of nursing care homes.
Read the detailed description
This is a prospective, quasi-experimental, controlled study with a mixed methods design with qualitative and quantitative components.
- Conditions
- Urinary Incontinence
- Being tested
- TENA Identifi
- Keywords
- Nursing homes, quasi-experimental, mixed methods, parallel study, urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENA IdentifiDevice
TENA Identifi
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Tena Identifi is an integrated electronic monitoring system based upon a wearable continence pad which allows registration of resident's micturition patterns over a 72 hour period, allowing caregivers to construct an individualised continence care plan, including use of appropriate products.
To create a voiding report, a resident wears the Identifi Sensor Wear with an attached Identifi Logger for three consecutive days (72 hours). The logger continuously logs the moisture status of the brief. The resulting data is sent to a server via 3 G signal where it is mapped onto a graph indicating voiding times and volumes. Receives: Device: TENA Identifi |
| Control Intervention | No intervention | The control portion of the study is "usual care", defined as the routine practices and procedures, including continence assessment approach, prescribed in the nursing home unit or facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group change in the proportion of residents with a one category change in continence products usage
Measured: 8 weeks
Secondary outcomes (10)
Between group change in time for construction of continence care plan following assessment
Measured: 8 weeks
Between group change in number of pads used
Measured: 8 weeks
Between group change in proportion of residents with pad leakage episodes
Measured: 8 weeks
Between group change in change in cost of continence products
Measured: 8 weeks
Between group change in change in healthcare aide / personal support worker time spent in continence care
Measured: 8 weeks
Between group change in Quality of life, measured by QoL AD
Measured: 8 weeks
Between group change in Activities of daily living as measured by Barthel index
Measured: 8 weeks
Between group change in number of wet checks at night
Measured: 8 weeks
Between group change in reduction in number of residents on "timed toileting schedules"
Measured: 8 weeks
Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start2 Jan 2018
- Primary completion30 Oct 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- SCA Hygiene Products, AB
- Responsible party
- Principal investigator, Adrian Wagg, University of Alberta
- Investigators
- Adrian S Wagg, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511314
- Sponsor's protocol ID
- ARC-NH-1205
- Acronym
- ARCTICC
- Status last verified
- Jan 2021
- First submitted
- 12 May 2015
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu P, Hailey D, Fleming R, Traynor V. An exploration of the effects of introducing a telemonitoring system for continence assessment in a nursing home. J Clin Nurs. 2014 Nov;23(21-22):3069-76. doi: 10.1111/jocn.12538. Epub 2014 Jan 31.
PubMed 24479697Nikoletti S, Young J, King M. Evaluation of an electronic monitoring device for urinary incontinence in elderly patients in an acute care setting. J Wound Ostomy Continence Nurs. 2004 May-Jun;31(3):138-49. doi: 10.1097/00152192-200405000-00008.
PubMed 15867743Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668.
PubMed 19191259Roe B, Flanagan L, Jack B, Shaw C, Williams K, Chung A, Barrett J. Systematic review of descriptive studies that investigated associated factors with the management of incontinence in older people in care homes. Int J Older People Nurs. 2013 Mar;8(1):29-49. doi: 10.1111/j.1748-3743.2011.00300.x. Epub 2011 Dec 19.
PubMed 22182302Rajabali SN, Hunter KF, Asaana P, McCreary ML, Nazari S, Wagg AS. Effectiveness of a Smart Urinary Continence Care Assessment System for Nursing Home Residents: A Quasi-Experimental, Sequential Quantitative-Qualitative Methods Trial. J Wound Ostomy Continence Nurs. 2023 Jan-Feb 01;50(1):48-56. doi: 10.1097/WON.0000000000000937.
PubMed 36640164
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
- ClinicalTrials.gov ID
- NCT02511314
- Acronym / sponsor ID
- ARCTICC / ARC-NH-1205
- Conditions
- Urinary Incontinence
- Keywords
- Nursing homes, quasi-experimental, mixed methods, parallel study, urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- SCA Hygiene Products, AB
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 30 Jul 2015 (estimated)
- 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 purpose of this study is to compare the use of an electronic incontinence identification system with nursing home support (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older residents of nursing care homes.
Detailed description
This is a prospective, quasi-experimental, controlled study with a mixed methods design with qualitative and quantitative components.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: TENA IdentifiTena Identifi is an integrated electronic monitoring system based upon a wearable continence pad which allows registration of resident's micturition patterns over a 72 hour period, allowing caregivers to construct an individualised continence care plan, including use of appropriate products. To create a voiding report, a resident wears the Identifi Sensor Wear with an attached Identifi Logger for three consecutive days (72 hours). The logger continuously logs the moisture status of the brief. The resulting data is sent to a server via 3 G signal where it is mapped onto a graph indicating voiding times and volumes. |
| Control Intervention | No intervention | –The control portion of the study is "usual care", defined as the routine practices and procedures, including continence assessment approach, prescribed in the nursing home unit or facility. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Nursing homes: A facility which:
- Residents: Nursing home residents over the age of 65 requiring a continence assessment upon entry to the nursing home or requiring a reassessment because of either a change in clinical status or provincial requirement shall be eligible for entry
Key exclusion criteria (6 listed)
- Residents
- Staff and Managers - Staff who did not take the training on the Identifi system or managers whose units that did not participate in the study will be ineligible for the focus group.
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 |
|---|---|---|
| TENA IdentifiTENA Identifi | Device | Intervention |
Primary outcome
Between group change in the proportion of residents with a one category change in continence products usage
Time frame: 8 weeks
10 secondary outcomes
Between group change in time for construction of continence care plan following assessment
Time frame: 8 weeks
Between group change in number of pads used
Time frame: 8 weeks
Between group change in proportion of residents with pad leakage episodes
Time frame: 8 weeks
Between group change in change in cost of continence products
Time frame: 8 weeks
Between group change in change in healthcare aide / personal support worker time spent in continence care
Time frame: 8 weeks
Between group change in Quality of life, measured by QoL AD
Time frame: 8 weeks
Between group change in Activities of daily living as measured by Barthel index
Time frame: 8 weeks
Between group change in number of wet checks at night
Time frame: 8 weeks
Between group change in reduction in number of residents on "timed toileting schedules"
Time frame: 8 weeks
Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group
Time frame: 8 weeks
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 25 Jan 2021.
- Background: PubMed 24479697Yu P, Hailey D, Fleming R, Traynor V. An exploration of the effects of introducing a telemonitoring system for continence assessment in a nursing home. J Clin Nurs. 2014 Nov;23(21-22):3069-76. doi: 10.1111/jocn.12538. Epub 2014 Jan 31.
- Background: PubMed 15867743Nikoletti S, Young J, King M. Evaluation of an electronic monitoring device for urinary incontinence in elderly patients in an acute care setting. J Wound Ostomy Continence Nurs. 2004 May-Jun;31(3):138-49. doi: 10.1097/00152192-200405000-00008.
- Background: PubMed 19191259Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668.
- Background: PubMed 22182302Roe B, Flanagan L, Jack B, Shaw C, Williams K, Chung A, Barrett J. Systematic review of descriptive studies that investigated associated factors with the management of incontinence in older people in care homes. Int J Older People Nurs. 2013 Mar;8(1):29-49. doi: 10.1111/j.1748-3743.2011.00300.x. Epub 2011 Dec 19.
- Derived from this study: PubMed 36640164Rajabali SN, Hunter KF, Asaana P, McCreary ML, Nazari S, Wagg AS. Effectiveness of a Smart Urinary Continence Care Assessment System for Nursing Home Residents: A Quasi-Experimental, Sequential Quantitative-Qualitative Methods Trial. J Wound Ostomy Continence Nurs. 2023 Jan-Feb 01;50(1):48-56. doi: 10.1097/WON.0000000000000937.
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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.
Adrian S Wagg, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENA Identifi in people with Urinary Incontinence, run by University of Alberta at 1 site in Canada.
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 6 inclusion and 6 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Between group change in the proportion of residents with a one category change in continence products usage (time frame: 8 weeks). 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 NCT02511314, which also lists 5 linked publications.
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 25 Jan 2021.