Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04331340 |
| Other study ID # |
Pro00097144 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2021 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
