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临床试验/NCT02875977
NCT02875977已完成不适用

Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?

Elizabeth Mueller2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Number of Participants With Completed PT Visits

研究概览

简要总结

The investigators intend to measure compliance with attending pelvic floor physical therapy (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute educational video or reading a handout explaining the therapy.

详细描述

Patients who have been interviewed, examined, and a plan has been made by the treating physicians in the Female Pelvic Medicine & Reconstructive Surgery practice will be invited to participate at the end of the visit if the patient and physician mutually agree that PFPT is the treatment modality to pursue.

If she agrees to participate, she will be consented and randomized. If she is randomized to standard counseling, she will be given the standard handout to read. If she is randomized to the intervention, she will receive the standard handout and view the 4-minute educational video on an iPad.

At the conclusion of the counseling, patients will be asked if they have any additional questions, and these will be recorded and answered. The patient will also fill out a visual analog scale about how informed she feels regarding PFPT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

No masking is used in this study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine & Reconstructive Surgery practice

排除标准

  • Patients ≤ 18 years old

研究组 & 干预措施

Experimental Counseling

Experimental

Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.

干预措施: Educational video (Other)

Experimental Counseling

Experimental

Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.

干预措施: Educational handout (Other)

Standard Counseling

Active Comparator

Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.

干预措施: Educational handout (Other)

结局指标

主要结局

Number of Participants With Completed PT Visits

时间窗: 3 months

The number of patients who completed at least half of their recommended PFPT visits is compared between those assigned to enhanced counseling versus standard counseling

次要结局

  • PFPT Discharge(3 months)
  • Change in Urogenital Distress From Baseline to 3 Months(3 months)
  • Initiation of PFPT(3 months)
  • Days to Initiation of PFPT(3 months)

研究者

发起方
Elizabeth Mueller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elizabeth Mueller

MD, Associate Professor

Loyola University

研究点 (2)

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