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Идёт набор NCT07320651

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults

Без фазы С лечением Contraception Menstrual Management

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: Encounter decision aid, Standard counseling.
Кому может быть актуально
Состояния в реестре: Contraception, Menstrual Management. Базовые параметры: 12 лет — 25 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
Швейцария
Следующий шаг
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Официальное название

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial

Обзор

Decision aids are educational tools designed to help people participate in decision-making about health care choices, by providing evidence-based information, promoting patient-centered care, and supporting patient autonomy and engagement. Our research team developed an Encounter Decision Aid (EDA) exploring treatment options for menstrual management in adolescents and young adults (AYAs), in accordance with the latest International Patient Decision Aids Standards and the Ottawa Decision Support Framework. In this cluster-randomized controlled trial, we aim to evaluate the effectiveness of this EDA on patient-centered outcome measures in AYAs considering treatment for menstrual management and/or contraception compared to standard counseling.

Вмешательства

  • Другое Encounter decision aid
    The intervention will involve the use of an encounter decision aid (EDA) during the clinical encounter. This paper-based tool was developed through an iterative process at HUG by our multidisciplinary team, comprising clinicians, specialized nurses, clinical researchers, graphic designer, stakeholders and patient representatives.
  • Другое Standard counseling
    The control intervention consists of standard consultation with usual counseling.

Первичные конечные точки

  • Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS). [Срок оценки: immediately after the clinical encounter]
Вторичные конечные точки (9)
  • Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS). [Срок оценки: at 3 months post-clinical encounter]
  • Patient knowledge. [Срок оценки: immediately after the clinical encounter]
  • Knowledge retention [Срок оценки: knowledge questionnaire at 3 months post-intervention]
  • Patient and healthcare provider satisfaction with the decision-making process [Срок оценки: immediately after the clinical encounter]
  • Patient involvement in decision-making [Срок оценки: immediately after the clinical encounter (10-point Likert scale).]
  • Patient involvement in decision-making [Срок оценки: immediately after the clinical encounter]
  • Participant treatment preference before the clinical encounter [Срок оценки: Baseline]
  • Participant treatment preference after the clinical encounter [Срок оценки: Immediately after the clinical encounter]
  • Medication continuation [Срок оценки: at 3 months]

Критерии участия

Критерии включения

  • adolescents and young adults aged 12-25 years old
  • presenting to an outpatient consultation at "Unité de policlinique de gynécologie" or "Consultation de gynécologie pédiatrique" at HUG
  • considering initiation or switch to hormonal medication for menstrual management and/or contraception
  • able to give informed consent as documented by signature or accompanied by a legal guardian who can provide consent if required.

Критерии исключения

  • individuals who cannot read and understand French to a degree that would prevent participation in informed consent and study-related materials.
  • individuals who have major sensory disability, such as visual or hearing impairment, that would compromise their ability to give written informed consent and use the EDA, in the absence of their legal guardian.
  • individuals with cognitive or psychiatric conditions significantly impairing decision making capacity, unless accompanied by a legal guardian.
  • patients currently participating in another clinical trial related to contraceptive decision-making, to avoid potential interference.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • Geneva University Hospitals — Geneva

Идентификаторы

NCT: NCT07320651 · 2025-00733

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗