Effect of Treatment Dairy for Spasticity
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Spasticity, Muscle. Базовые параметры: Без ограничений · 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.
Обзор
1. Assessing whether the treatment diary can help optimize the overall treatment of patients. 2. To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals. 3. To assess whether the patient's quality of life is increased by the use of the treatment diary.
Подробное описание
Hypothesis:
A treatment diary will increase the patient's awareness of which spasticity symptoms are significant and can enable the patients to evaluate the treatment more easily.
This will result in more relevant treatment goals. At the same time the treatment can be better addressed to the individual patient at routine controls. In addition, the treatment diary will result in closer cooperation between the physiotherapists and occupational therapists and the physician who administers the botulinum toxin. This collaboration is expected to lead to better common goals and optimization of treatment.
Finally, it is expected that the above will help to increase the patient's quality of life.
Первичные конечные точки
- Patient becomes more satisfied with their treatment using the treatment diary [Срок оценки: October 2019]
Вторичные конечные точки (2)
- To assess if the patient's quality of life is improved using the treatment diary. [Срок оценки: October 2019]
- The patients' assessment of the treatment diary will be described (Questionnaire 3). [Срок оценки: October 2019]
Критерии участия
Критерии включения
- Patients must have received at least two previous treatments before inclusion, ie. with approx. 3 months apart, and it is assessed that the patients have good effect of the treatments in relation to the agreed treatment goals.
Критерии исключения
- Patients where changes are planned regarding their treatment for muscle overactivity during the study period.
Patients where the disease is not stable and where it may have a major influence on the treatment effect of botulinum toxin treatment during the study period and where it can be difficult to set SMART (Specific, Measurable, Accepted, Realistic, Timed) goals.
Patients who have previously been treated and have used a treatment diary in connection with the botulinum toxin treatment.
Patients who can not collaborate on completing goals and evaluating treatment effect due to language or cognitive problems.
Patients who at the same time are being treated with botulinum toxin in the bladder.
If significant changes occur in the patient's health, which may involve new cancer, stroke, multiple sclerosis attack, etc. during the study period, the participant will be withdrawn from the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-кроссовер
Центры проведения
Дания · 1 центр
- Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup — Glostrup Municipality
Идентификаторы
NCT: NCT03384927 · RH-2017-292