Набор скоро начнётся NCT07252089

Development and Application of a Decision-Making Aid Tool for Amputation Surgery in Diabetic Foot Patients Based on the Ottawa Decision Support Framework

Без фазы С лечением Diabetic Foot 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: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients, Routine Clinical Consultation and Nursing Care.
Кому может быть актуально: Состояния в реестре: Diabetic Foot Disease. Базовые параметры: от 18 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: Список центров уточняется — проверьте первичный протокол.
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

Impact of Decision Support Tools on Amputation Decisions in Diabetic Foot Patients: A Quasi-Experimental Study

Обзор

To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.

Подробное описание

Through a clinical controlled study, the nurse-assisted intervention group utilized the Decision-Making Aid Tool for Amputation in Diabetic Foot Patientsto assess patients' treatment choice stages, provide disease-related knowledge, and clarify the advantages and disadvantages of different treatment options. This tool also helped patients articulate their values and preference biases. Subsequently, a questionnaire survey was conducted to evaluate decisional conflict, decisional expectations, and decisional satisfaction between the two groups, aiming to assess the tool's application efficacy.

Вмешательства

Процедура Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients
In addition to receiving routine clinical consultations and nursing care identical to the control group, the intervention group will utilize an electronic decision-making aid for diabetic foot amputation. We will design this electronic tool and deliver it to participants via a WeChat Mini Program. Patients will be instructed to spend no more than 60 minutes using the tool, with researchers supervising their sessions and providing assistance as needed. During the study period, the electronic deci
Процедура Routine Clinical Consultation and Nursing Care
Patients received routine clinical consultation and nursing care before and after random assignment.

Первичные конечные точки

Decisional Conflict Scale，DCS [Срок оценки: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively]

Вторичные конечные точки (3)

The Control Preference Scale，CPS [Срок оценки: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively]
The Satisfaction with Decision Scale，SWD [Срок оценки: Three days post-surgery ；One month postoperatively]
Decision Regret Scale,DRS [Срок оценки: Three days post-surgery；One month postoperatively]

Критерии участия

Критерии включения

Diabetic foot ulcers with Wagner grade 4 or higher gangrene. Diabetic foot ulcers with Wagner grade 3 accompanied by severe infection or systemic symptoms; severe local infections, or chronic osteomyelitis causing functional impairment of the limb.

Patients with lower extremity vascular disease showing progression despite systemic treatment.

IWGDF stage 3 severe infections (characterized by loss of protective sensation or peripheral arterial disease, with at least one of the following: history of foot ulcer, lower limb amputation, or end-stage renal disease).