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Идёт набор NCT06002763

Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women

— Наблюдательное Well-Being, Psychological

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System), WHOQoLBREF (World Health Organization Quality of Life Brief Version), EQ-5D-3L1 (not an acronym).
Кому может быть актуально
Состояния в реестре: Well-Being, Psychological. Базовые параметры: 18 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for the assessment of these factors in a generic population, but has not been specifically evaluated for use with postpartum women. This study is a longitudinal, single center observational cohort study designed to evaluate the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. While this survey has shown utility in other populations, it has yet to be assessed in an obstetric population. The investigators plan to recruit patients who are recently postpartum from vaginal or cesarean delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after delivery). The investigators will subject survey data to statistical measures of validity and reliability comparing with contemporaneously collected surveys of established metrics for quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score 1-100). The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable means of assessing physical and mental health in a postpartum population.

Вмешательства

  • Другое PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)
    PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.
  • Другое WHOQoLBREF (World Health Organization Quality of Life Brief Version)
    The WHOQOL-BREF is a 26-item version of the 100-item WHOQOL-100 quality of life measure that addresses four quality of life domains: physical health, psychological health, social relationships and environment.
  • Другое EQ-5D-3L1 (not an acronym)
    The EQ-5D-3L1 is a generic measure of health status consisting of two parts. The first part assesses health in five dimensions: MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY/DEPRESSION. The second part of the questionnaire consists of a VAS on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Первичные конечные точки

  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [Срок оценки: 24 hours]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [Срок оценки: 24 hours]
  • EQ-5D-3L1 (not an acronym) survey score [Срок оценки: 24 hours]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [Срок оценки: 2 weeks]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [Срок оценки: 2 weeks]
  • EQ-5D-3L1 (not an acronym) survey score [Срок оценки: 2 weeks]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [Срок оценки: 6 weeks]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [Срок оценки: 6 weeks]
  • EQ-5D-3L1 (not an acronym) survey score [Срок оценки: 6 weeks]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • 18 years old and over
  • singleton births
  • 37 or more weeks gestational age
  • multiparous or nulliparous patients
  • spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or neuraxial anesthesia
  • give informed written consent

Критерии исключения

  • refusal to take part
  • are unable to give or have withdrawn consent
  • patients unable to communicate fluently in English
  • patients who are less than 18 years old
  • patients who had fetal demise or severely morbid fetal conditions such as intubation, cooling, expected surgical correction of congenital anomaly during hospitalization (although NICU admissions will be included)
  • patients who were admitted in ICU
  • patients who had failed neuraxial analgesia such as replaced epidurals or failed spinal requiring conversion to general anesthesia
  • patients who had general anesthesia for cesarean delivery as defined by "GETA", including sedatives and deep sedation if not intubated
  • patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum, forceps) vaginal delivery.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Mount Sinai Hospital — Toronto

Идентификаторы

NCT: NCT06002763 · 23-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗