A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Patient Perception of Bladder Condition (PPBC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥60 years
- •Report lower urinary tract symptoms (LUTS)
- •Read and communicate in English
排除标准
- •Age ≤ 59 years
- •Deny LUTS
- •Refuse to consent
- •Unavailable or unable to participate in follow-up visits
结局指标
主要结局
Change in Patient Perception of Bladder Condition (PPBC)
时间窗: Change from baseline to 8 weeks post-intervention
Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems
次要结局
- Change in Bladder Self-Assessment Questionnaire (B-SAQ)(Change from baseline to 8 weeks post-intervention)
- Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)(Change from baseline to 8 weeks post-intervention)