Briefs With Tapes Versus Pull Ups for Urinary Incontinence in Older People With Mild to Moderate Dementia (CUPID) (CUPID)
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pull Ups
Styled Briefs with tapes
Sponsored by
About this trial
This is an interventional other trial for Urinary Incontinence focused on measuring Urinary Incontinence, Dementia, Randomised Cross Over Trial, continence products
Eligibility Criteria
Inclusion Criteria:
- Able to toilet independently or independently following prompting or instruction to do so.
- Independently mobile, with or without walking aids
- Use of any type of continence produce, for the management of moderate incontinence.
- Moderate incontinence severity as measured by Incontinence Severity (Sandvik) index.
- Availability of care partner willing to co-operate and participate in trail procedures
Exclusion Criteria:
- Need for daily help with dexterity to apply any continence product
- Waist size or body shape which renders any size of either investigational product inapplicable
- PLWD unable to indicate the need to toilet
- PLWD with significant faecal incontinence
- Permanent residence in nursing home or expected to enter nursing home within two months of trail entry
- Presence of any other condition, which, in the opinion of the investigator makes PLWD unable to participate in the necessary trail procedures.
Sites / Locations
- Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta HospRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pull ups
Styled briefs with tapes
Arm Description
Pull-up continence products
Styled briefs with tapes
Outcomes
Primary Outcome Measures
Number of Successful Toileting Episodes
Between group change in the proportion of "successful toileting episodes", defined as episodes of independent toileting with pad use and reapplication without leakage, misapplication or failure, between baseline measurement and end of study investigational product.
Secondary Outcome Measures
Number of continence products used
Number of products used in excess of those deemed necessary [2/24h] according to degree of incontinence.
Number of unintentional leakage
Number of unintentionally leaking products due to misapplication, average per 24h over the duration of the study
Number of episodes leading to unintentionally soiled or wet clothing
Difference in number of episodes leading to wet or unintentionally soiled clothing, between investigational products over the duration of the study.
Number of laundry episodes
Differences in number of laundry episodes(either clothes or bed linen) between investigational products over the duration of the study
Number of hours of care partner time
Difference in care partner time in maintaining continence with investigational products and toileting over the duration of the study
Cost of care partner time
Difference in care partner cost (costed at minimum wage per hour) in maintaining continence with investigational products and toileting over the duration of the study
Quality of life at baseline and end of study
Change in quality of life measures between baseline assessment and end of study using Quality of Life Alzheimer Disease (ADQoL) validated questionnaire.
The ADQoL scores can be calculated based on patient and caregiver reports and can be combined into a single score, with total scores range from 13 to 52, with higher scores indicating better QoL
Zarit burden index
Comparison of change in Zarit burden index between baseline and end of investigational product use compared between products. Zarit burden index consists of 22 items used to calculate a total score that can range between 0 and 88 (88 = more burden)
Number of Care Partners satisfied with treatment
Persons living with dementia and care partner assessment of satisfaction with each investigational product and its use, assessed at the end of each testing period
Number of PLWD satisfied with treatment
Impressions of ease of use and user satisfaction on the part of persons living with dementia and care partner, at the end of each period of investigational product use, assessed by semi-structured interview
Full Information
NCT ID
NCT04290403
First Posted
December 5, 2019
Last Updated
March 24, 2023
Sponsor
University of Alberta
Collaborators
Essity Hygiene and Health AB
1. Study Identification
Unique Protocol Identification Number
NCT04290403
Brief Title
Briefs With Tapes Versus Pull Ups for Urinary Incontinence in Older People With Mild to Moderate Dementia (CUPID)
Acronym
CUPID
Official Title
A Randomised Cross Over Trial of Briefs With Tapes Versus Pull Ups for the Containment of Urinary Incontinence in Community Dwelling Older People Living With Mild to Moderate Dementia (CUPID)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Essity Hygiene and Health AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Urinary incontinence is a common health problem that significantly affects the quality of life of older people. The risk of urinary incontinence is increased in people living with dementia. Many products aid the management of urinary incontinence, with many people choosing to manage incontinence with containment products. The purpose of this study is to examine and compare two containment products - pull ups and style briefs with tapes, in self-management of urinary incontinence in people living with dementia.
Detailed Description
Urinary incontinence is common in later life and the risk of incontinence is increased in people living with dementia (PLWD). For many, incontinence is managed with toileting assistance containment products, regardless of other potential treatments. As toileting becomes more difficult and incontinence more likely, a containment product which mimics normal underwear, which is familiar to the PLWD may be an attractive option to preserve successful toileting and self management of continence with containment products and toileting for as long as possible. This study is designed to explore the relative benefits or disadvantages of containment with either briefs with tapes or pull ups in the self management of continence by containment products and toileting in PLWD.
Primary objective
To examine the benefits and disadvantages of self-management of urinary incontinence by pulls compared to style briefs with tapes in PLWD.
Research Method/Procedures
This study will comprise a three-phase design
A small sample, exploratory study to ascertain the feasibility of recruitment, trial design and conduct and to enable calculation of an effect size for the trial primary outcome including care partner interviews and exploration of qualitative factors in use not captured elsewhere, economic variables and costs.
A crossover study with an interval washout (pre-trial care) period. Each participant will undergo a 3-day assessment of incontinence severity to ensure eligibility and then, in random order, a four-week period of use of one investigational product, a two week return to their usual care (the care methods undertaken prior to trial commencement) and then a four-week period of use of the comparative investigational product.
A post-treatment phase, qualitative semi-structured interview with PLWD and their care partners to discuss the impressions of the use of each investigational product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Dementia, Randomised Cross Over Trial, continence products
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover trial of briefs with tapes versus pull ups for the containment of urinary incontinence
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pull ups
Arm Type
Experimental
Arm Description
Pull-up continence products
Arm Title
Styled briefs with tapes
Arm Type
Experimental
Arm Description
Styled briefs with tapes
Intervention Type
Device
Intervention Name(s)
Pull Ups
Intervention Description
Participants will be asked to wear pull-ups continence products for the duration of four weeks
Intervention Type
Device
Intervention Name(s)
Styled Briefs with tapes
Intervention Description
Participants will be asked to wear styled briefs with tapes for the duration of four weeks
Primary Outcome Measure Information:
Title
Number of Successful Toileting Episodes
Description
Between group change in the proportion of "successful toileting episodes", defined as episodes of independent toileting with pad use and reapplication without leakage, misapplication or failure, between baseline measurement and end of study investigational product.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Number of continence products used
Description
Number of products used in excess of those deemed necessary [2/24h] according to degree of incontinence.
Time Frame
56 days
Title
Number of unintentional leakage
Description
Number of unintentionally leaking products due to misapplication, average per 24h over the duration of the study
Time Frame
56 days
Title
Number of episodes leading to unintentionally soiled or wet clothing
Description
Difference in number of episodes leading to wet or unintentionally soiled clothing, between investigational products over the duration of the study.
Time Frame
56 days
Title
Number of laundry episodes
Description
Differences in number of laundry episodes(either clothes or bed linen) between investigational products over the duration of the study
Time Frame
56 days
Title
Number of hours of care partner time
Description
Difference in care partner time in maintaining continence with investigational products and toileting over the duration of the study
Time Frame
56 days
Title
Cost of care partner time
Description
Difference in care partner cost (costed at minimum wage per hour) in maintaining continence with investigational products and toileting over the duration of the study
Time Frame
56 days
Title
Quality of life at baseline and end of study
Description
Change in quality of life measures between baseline assessment and end of study using Quality of Life Alzheimer Disease (ADQoL) validated questionnaire.
The ADQoL scores can be calculated based on patient and caregiver reports and can be combined into a single score, with total scores range from 13 to 52, with higher scores indicating better QoL
Time Frame
56 days
Title
Zarit burden index
Description
Comparison of change in Zarit burden index between baseline and end of investigational product use compared between products. Zarit burden index consists of 22 items used to calculate a total score that can range between 0 and 88 (88 = more burden)
Time Frame
56 days
Title
Number of Care Partners satisfied with treatment
Description
Persons living with dementia and care partner assessment of satisfaction with each investigational product and its use, assessed at the end of each testing period
Time Frame
56 days
Title
Number of PLWD satisfied with treatment
Description
Impressions of ease of use and user satisfaction on the part of persons living with dementia and care partner, at the end of each period of investigational product use, assessed by semi-structured interview
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to toilet independently or independently following prompting or instruction to do so.
Independently mobile, with or without walking aids
Use of any type of continence produce, for the management of moderate incontinence.
Moderate incontinence severity as measured by Incontinence Severity (Sandvik) index.
Availability of care partner willing to co-operate and participate in trail procedures
Exclusion Criteria:
Need for daily help with dexterity to apply any continence product
Waist size or body shape which renders any size of either investigational product inapplicable
PLWD unable to indicate the need to toilet
PLWD with significant faecal incontinence
Permanent residence in nursing home or expected to enter nursing home within two months of trail entry
Presence of any other condition, which, in the opinion of the investigator makes PLWD unable to participate in the necessary trail procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian S Wagg, MD
Phone
780-492-5338
Email
adrian.wagg@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Rajabali, MBBS
Phone
780-492-3700
Email
srajabali@ualberta.ca
Facility Information:
Facility Name
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Wagg, MD
Phone
780 492 5338
Email
adrian.wagg@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Saima Rajabali, MBBS
Phone
780 492 3700
Email
srajabal@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Adrian S Wagg, MD
First Name & Middle Initial & Last Name & Degree
Saima Rajabali, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1202204
Citation
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Results Reference
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Results Reference
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Citation
Logsdon, R.G., , Gibbons, L.E., McCurry, S.M., Teri, L., Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of mental health and ageing, 1999. 5: p. 21-25.
Results Reference
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PubMed Identifier
29509292
Citation
Volz-Sidiropoulou E, Rings T, Wagg AS, Leistner N, Gauggel S, Kirschner-Hermanns R. Development and initial psychometric properties of the 'ICIQ-Cog': a new assessment tool to measure the disease-related impact and care effort associated with incontinence in cognitively impaired adults. BJU Int. 2018 Aug;122(2):309-316. doi: 10.1111/bju.14186. Epub 2018 Apr 10.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Gotoh M, Matsukawa Y, Yoshikawa Y, Funahashi Y, Kato M, Hattori R. Impact of urinary incontinence on the psychological burden of family caregivers. Neurourol Urodyn. 2009;28(6):492-6. doi: 10.1002/nau.20675.
Results Reference
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Citation
Hérbert, R., Bravo, G., & Préville, M., Reliability, validity, and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia. Canadian Journal on Aging, 2000. 19: p. 494-507.
Results Reference
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Citation
Lesen E, Bjorholt I, Ingelgard A, Olson FJ. EXPLORATION AND PREFERENTIAL RANKING OF PATIENT BENEFITS OF MEDICAL DEVICES: A NEW AND GENERIC INSTRUMENT FOR HEALTH ECONOMIC ASSESSMENTS. Int J Technol Assess Health Care. 2017 Jan;33(4):463-471. doi: 10.1017/S0266462317000848. Epub 2017 Oct 25.
Results Reference
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Learn more about this trial
Briefs With Tapes Versus Pull Ups for Urinary Incontinence in Older People With Mild to Moderate Dementia (CUPID)
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