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Идёт набор NCT06309316

The Impact of Person Centred Care (PCC) in Grave's Disease

Без фазы С лечением Graves Disease

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: Person-centred care (PCC).
Кому может быть актуально
Состояния в реестре: Graves Disease. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project

Обзор

Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will: WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality. WP2 Investigate the cost-effectiveness of the intervention Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness.

Вмешательства

  • Поведенческое Person-centred care (PCC)
    In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. Primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.

Первичные конечные точки

  • Composite score of changes [Срок оценки: Change from baseline examined at 3 months follow-up.]
Вторичные конечные точки (12)
  • General Self-Efficacy Scale (GSE) [Срок оценки: Change from baseline examined at 6 weeks follow-up.]
  • General Self-Efficacy Scale (GSE) [Срок оценки: Change from baseline examined at 3 months follow-up.]
  • General Self-Efficacy Scale (GSE) [Срок оценки: Change from baseline examined at 6 months follow-up.]
  • General Self-Efficacy Scale (GSE) [Срок оценки: Change from baseline examined at 15 months follow-up.]
  • Days of sick-leave [Срок оценки: Change from baseline examined at 6 weeks follow-up.]
  • Days of sick-leave [Срок оценки: Change from baseline examined at 3 months follow-up.]
  • Days of sick-leave [Срок оценки: Change from baseline examined at 6 months follow-up.]
  • Days of sick-leave [Срок оценки: Change from baseline examined at 15 months follow-up.]
  • Mental fatigue score [Срок оценки: Change from baseline examined at 6 weeks follow-up.]
  • Mental fatigue score [Срок оценки: Change from baseline examined at 3 months follow-up.]
  • Mental fatigue score [Срок оценки: Change from baseline examined at 6 months follow-up.]
  • Mental fatigue score [Срок оценки: Change from baseline examined at 15 months follow-up.]

Критерии участия

Критерии включения

  • Age 18-65 years
  • First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)

Критерии исключения

  • Patients that cannot attend to the protocol
  • Patients with moderate-severe/ severe Graves' eye disease

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
Поддерживающая терапия

Центры проведения

Швеция · 1 центр
  • Agneta Lindo — Gothenburg

Идентификаторы

NCT: NCT06309316 · Grace-PCC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗