Outcomes of a Multidisciplinary Program for the Treatment of Chronic Pelvic Pain

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Chronic Pelvic Pain Treatment Guide
  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.

Первичные конечные точки

• Patient Satisfaction [Срок оценки: at several intervals over the course of 1 year]

Вторичные конечные точки (2)

• Pain Catastrophizing [Срок оценки: at several intervals over the course of 1 year]
• Pelvic Pain [Срок оценки: at several intervals over the course of 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MedStar Washington Hospital Center — Washington D.C.

Идентификаторы

NCT: NCT06317233 · STUDY00007131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗