Management of LUTS by Community Pharmacists

NCT04331340

Last updated date
Study Location
University of Alberta
Edmonton, Alberta, T6G1C9, Canada
Contact
7804925078

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lower Urinary Tract Symptoms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age ≥60 years

- Report lower urinary tract symptoms (LUTS)

- Read and communicate in English

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Age ≤ 59 years


- Deny LUTS


- Refuse to consent


- Unavailable or unable to participate in follow-up visits

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Lower Urinary Tract SymptomsManagement of LUTS by Community Pharmacists
NCT04331340
  1. Edmonton, Alberta
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Other: Pharmacist review of LUTS
    Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications
  • Other: Pharmacist Provision of healthy aging leaflets
    Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets
Study Arms  ICMJE
  • Experimental: Pharmacist Intervention
    Pharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks.
    Intervention: Other: Pharmacist review of LUTS
  • Active Comparator: Control
    Pharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks.
    Intervention: Other: Pharmacist Provision of healthy aging leaflets
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
 (submitted: March 31, 2020)
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:

  • Age ?60 years
  • Report lower urinary tract symptoms (LUTS)
  • Read and communicate in English

Exclusion Criteria:

  • Age ? 59 years
  • Deny LUTS
  • Refuse to consent
  • Unavailable or unable to participate in follow-up visits
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cheryl A Sadowski, Pharm.D.7804925078[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Subject demographics and scores of the primary and secondary outcomes measures will be shared at all time points.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Time Frame:After completion of the study in 2021, for 5 years.
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Cheryl A Sadowski, Pharm.D.University of Alberta
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