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Behavioural Intervention
Change Indicator for Urinary Incontinence
N/A
Waitlist Available
Led By Adrian Wagg, MD
Research Sponsored by Essity Hygiene and Health AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to show that the TENA SmartCare Change Indicator can make caring for people with urinary incontinence in nursing homes more efficient. The device alerts caregivers when a diaper needs changing, reducing the time spent on manual checks. The study will also monitor if this efficiency improvement affects skin health and overall quality of life.
Eligible Conditions
- Urinary Incontinence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Care Efficiency score
Daily Skin Health score
Secondary study objectives
Caregiver work conditions
Caregiver work engagement
Level of agitation and responsive behavior.
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
Clusters in this arm will start using the device and use it for 6 weeks.
Group II: ControlActive Control1 Intervention
Clusters in this arm will not receive the device it will continue with usual care with no changes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENA SmartCare Change Indicator
2022
N/A
~180
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Who is running the clinical trial?
Essity Hygiene and Health ABLead Sponsor
14 Previous Clinical Trials
637 Total Patients Enrolled
11 Trials studying Urinary Incontinence
559 Patients Enrolled for Urinary Incontinence
Adrian Wagg, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
910 Total Patients Enrolled
1 Trials studying Urinary Incontinence
910 Patients Enrolled for Urinary Incontinence
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using another automated or digital device to manage incontinence.You have frequent daily accidents with bowel movements or severe problems with controlling bowel movements as determined by the doctor.You have severe skin problems caused by using incontinence products.You rely on alcohol or recreational drugs.You have difficulty telling others when you need to use the bathroom.The person shows behaviors that make it difficult to take part in the study, according to the care staff.You do not produce urine.You have been told by a doctor that you have less than 3 months to live, or you are receiving comfort care because of a serious illness.You use incontinence products like tapes, belts, or pull-up types for moderate to heavy urinary incontinence.You need help using the toilet and changing pads.You are currently using a continence care routine that involves checking and changing a method.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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