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临床试验/NCT05858125
NCT05858125已完成不适用

Social Media Navigation Aid Kits for Urinary Incontinence

University of New Mexico4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
4
主要终点
Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS)

研究概览

简要总结

This study aims to compare the effectiveness of a Urogynecology Social Media Navigation Aid Kit (SNAK) and routine counseling in the treatment of women with newly diagnosed urinary incontinence. The study will conduct a randomized controlled trial on treatment-naïve patients seeking care for urinary incontinence. The research will have five aims:

  1. evaluate the impact of SNAK on patients' self-efficacy in managing urinary incontinence symptoms
  2. compare patient satisfaction with urinary incontinence treatment between SNAK and routine counseling groups
  3. assess the impact of SNAK on urinary incontinence severity
  4. evaluate the impact of SNAK on patients' quality of life
  5. examine if there is an impact of SNAK on patients' treatment decision.

Participants will be randomized to routine counseling alone versus routine counseling plus a SNAK. They will be given a baseline survey at their initial enrollment to the study. The investigators will follow up at a 3-month interval where they will be given a post-intervention survey.

详细描述

The objective of this research is to perform a non-masked, superiority randomized controlled trial to assess urinary incontinence (UI) symptoms of women newly diagnosed with UI before and after conservative treatment with either a Urogynecology Social Media Navigation Aid Kit or routine counseling. The target population are treatment naïve patients with urinary incontinence who are seeking care as a new patient. Our central hypothesis is that the addition of a Urogynecology Social Media Navigation Aid Kit will be superior to routine counseling alone in women with urinary incontinence.

The investigators will recruit women with any type of urinary incontinence who present to the University of New Mexico Urogynecology practice at UNM Eubank Clinic (UNM) or Sandoval Regional Medical Center (SRMC). To confirm diagnosis and eligibility, The investigators will conduct a standard intake history and physical, complete with cough stress test, POP-Q pelvic examination, urinalysis, and urine culture. All potential participants will receive routine counseling about possible treatment options appropriate for her urinary incontinence, regardless of group assignment. Their follow up appointments will be the same regardless of participation in the study.

The intervention is a Social media Navigation Aid Kit (SNAK) which was created by using search terms, "urinary incontinence", "urinary leakage", and "urogynecology", and querying various websites/blogs, Facebook, Instagram, and YouTube. These social media platforms were chosen based on the top three social media platforms used in Americans aged 50 to >65 years old according to Pew Research Analytics (Pew paper). The experienced reviewer evaluated each platform for users that provided relevant, accurate, and specific content. The department of Urogynecology at UNM independently reviewed the curated pages and users for approval. Once approved, the various users and pages were then collected and an infographic was created. The infographic will be available via hardcopy (as a trifold), email, text, and/or via QR code per patient preference.

Potential subjects will be recruited in the UNM Eubank and SRMC clinics when they present for care for OAB/UUI, either in person or virtually via telephone or Zoom care visits. All patients will have a history and physical taken to determine their study eligibility. Recruitment will take place either in private exam rooms at these clinics or over HIPAA-compliant telephone or Zoom conversation. After recruitment, they will undergo the informed consent via the same means as recruitment and complete initial questionnaires in clinic or will be sent a copy (digital or mail) to read if enrolled virtually.

The randomization sequence will be generated by computer-based randomization in a sequence that preserves 1:1 randomization and also preserves allocation concealment (likely with randomly alternating block sizes of 6-10 in blocked randomization). Randomization assignments will be completed via REDCAP by a research coordinator. Randomization will only occur after consent has been signed and all baseline data has been obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

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

  • New or existing patients to the Urogynecology practice at the University of New Mexico or Sandoval Regional Medical Center having urinary incontinence treatment options discussed/addressed by our provider group for the first time.
  • Patients who report symptoms of urinary incontinence (defined as one or more episodes of involuntary urinary loss)
  • >18 years old
  • Willing to complete study questionnaires

排除标准

  • Age < 18 years
  • Presence of urinary fistula
  • Prior treatment of urinary incontinence
  • Prior consult with a urogynecologist for urinary incontinence
  • History of vaginal mesh complications
  • Pregnancy or planning to become pregnant in the next 3-4 months during the study per patient report
  • Cognitive impairment
  • No access to internet at home
  • Inability to speak/read/understand English

结局指标

主要结局

Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS)

时间窗: 3 month

We will measure self-efficacy using the NIH Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS). The PROMIS raw scores are translated into a "T-score", which rescales and standardizes the score where the mean U.S. general population score is fixed at 50 points and SD fixed at 10.

次要结局

  • Patient Global Impression of Improvement (PGI-I)(3 month)
  • IIQ-7-SF(3 months)
  • Incontinence Severity Index (ISI)(3 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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