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临床试验/NCT06317233
NCT06317233Enrolling By Invitation不适用

Outcomes of a Longitudinal Multidisciplinary Program for the Treatment of Chronic Pelvic Pain, Incorporating Online and Mobile Applications to Promote Self Efficacy

Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
40
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

The goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. The main questions it aims to answer are:

  • How does the handbook and follow-up impact patient satisfaction?
  • How does the handbook and follow-up impact patient pain and quality of life scores? Participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule.

详细描述

Chronic pelvic pain (CPP) is a common and multi-factorial condition resulting in high physical, emotional and psychological burden for patients. Multimodal treatments have been shown to be most effective in addressing the multifactorial nature of CPP, but remain challenging for patients and providers to navigate. Investigators have created a CPP treatment guide which clearly defines resources and management strategies in an effort to help patients understand their own diagnosis, treatment options and follow up schedule. The treatment guide includes mobile and web-based resources and applications specifically chosen to empower patients with information and to promote self-efficacy. The treatment guide is designed to be easily understood, visually appealing, and largely translatable from institution to institution. Patients using the treatment guide will be followed with a clearly defined follow up schedule, which includes touch points between appointments to aid with resource navigation. The investigators hypothesize that patients with CPP who are provided our treatment guide will experience improved satisfaction with their care, in addition to improved quality of life measures and pain scores as compared to those who undergo standard treatment.

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
None

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

  • Women age 18 or older
  • Diagnosis of chronic pelvic pain

排除标准

  • Primary language other than English
  • Pregnancy
  • Inability to attend follow-up appointment

结局指标

主要结局

Patient Satisfaction

时间窗: at several intervals over the course of 1 year

Measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18). The PSQ-18 yields separate scores for each of seven different subscales: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience. The items are scored so that high scores reflect satisfaction with medical care on a 1-5 scale.

次要结局

  • Pain Catastrophizing(at several intervals over the course of 1 year)
  • Pelvic Pain(at several intervals over the course of 1 year)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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