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Adult Trials: 18+ Years
- Age ≥60 years
- Report lower urinary tract symptoms (LUTS)
- Read and communicate in English
- Age ≤ 59 years
- Deny LUTS
- Refuse to consent
- Unavailable or unable to participate in follow-up visits
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- Edmonton, Alberta
| Descriptive Information | |||||||||||
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| Brief Title ICMJE | Management of LUTS by Community Pharmacists | ||||||||||
| Official Title ICMJE | A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community | ||||||||||
| Brief Summary | Many older adults have urinary incontinence. They often seek treatments, such as diapers, pads, or medications, from the community pharmacy. Pharmacists are trained to assist seniors with therapies that treat urinary incontinence. Our study will determine how much benefit there is if pharmacists try to provide more assistance for seniors with incontinence. Over a period of months, half of the people who talk to the pharmacist about their incontinence will be given general information about health and aging. The other half of the people will have a longer assessment and complete a questionnaire with the pharmacist. Then the pharmacist will call and have a follow-up visit to see how the incontinence symptoms have improved. We will compare both groups to see whose symptoms were improved. | ||||||||||
| Detailed Description | This randomized controlled trial is designed to determine the effect of a pharmacist intervention to manage lower urinary tract symptoms (LUTS) in the community. The objectives of the study are to determine the effect of the pharmacist as measured by the Patient Perception of Bladder Condition (PPBC) (primary objective), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) (as secondary objectives). The pharmacists at community pharmacies will be recruited through the networks already established within Alberta for pharmacy practice research, and the Pharmacists Association of Alberta. The pharmacists must have advanced prescribing authorization with their professional license. The patients will be recruited with the posting of shelf-talkers by the incontinence and menstrual products section of the pharmacy and with leaflets in prescription bags. If a patient obtains a LUTS product or if the patient presents him/herself in response to the shelf-talker, the pharmacist will screen the patient to determine if LUTS are present.The patients will be eligible to participate if they are at least 60 years of age, report LUTS, can communicate in English, and provide consent. The patient will be randomized to either a control or intervention. Those assigned to the control group will be eligible to receive the intervention following the follow-up period. Both the control and intervention group will have a baseline PPBC, B-SAQ, and ICI-Q-SF questionnaires, in addition to demographics and a medical history. The control group will receive a healthy aging pamphlet and will be called back at 8 weeks to have the questionnaires repeated. The intervention is based on the published guide for LUTS for pharmacists (Gabriel, et al. 2015). The pharmacist will assess the patient's LUTS and determine an appropriate intervention plan, which may include education, lifestyle, behavioural, or medication modification. The patient will be given a summary of the plan and the primary care provider will also receive a summary. At 4 weeks the patient will be contacted by phone or in person (per patient preference), with a review of the plan and repeated bladder questionnaires. At 8 weeks the patient will complete the final interaction with the pharmacist and will complete the bladder questionnaires for the final time. The primary outcome is the change in PPBC from baseline to 8 weeks, and secondary outcomes include the change from baseline until 8 weeks in the B-SAQ, ICI-Q, and health system use (including referrals to physicians, specialists, and pharmacist billing). We plan to enroll 100 patients (50 in each group). All analyses will be by intention to treat. | ||||||||||
| Study Type ICMJE | Interventional | ||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment | ||||||||||
| Condition ICMJE | Lower Urinary Tract Symptoms | ||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||
| Recruitment Information | |||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||
| Estimated Study Completion Date ICMJE | February 2021 | ||||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||||
| Removed Location Countries | |||||||||||
| Administrative Information | |||||||||||
| NCT Number ICMJE | NCT04331340 | ||||||||||
| Other Study ID Numbers ICMJE | Pro00097144 | ||||||||||
| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Alberta | ||||||||||
| Study Sponsor ICMJE | University of Alberta | ||||||||||
| Collaborators ICMJE | Pfizer | ||||||||||
| Investigators ICMJE |
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| PRS Account | University of Alberta | ||||||||||
| Verification Date | July 2020 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||||