About this trial
To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of psychiatric disorders with inability to cooperate during communication.
Trial design
Parallel
Treatments tested in this trial
Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients
Procedure/SurgeryIn 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 decision-making aid will remain confidential and accessible only to the intervention group, with restricted access for physicians and non-intervention patients.
Routine Clinical Consultation and Nursing Care
Procedure/SurgeryPatients received routine clinical consultation and nursing care before and after random assignment.
Treatment groups
Trial outcomes
Primary outcomes
Decisional Conflict Scale,DCS
The scale consists of 16 items and has undergone standardized conversion, with a total score of 100 points. A lower score indicates a lower level of decisional conflict in patients. A score \>25 suggests the presence of decisional conflict during the decision-making process, while a score \>37.5 indicates potential delays in decision-making
Secondary outcomes
The Control Preference Scale,CPS
The scale consists of five options, categorized into three decision-making types: Proactive, Cooperative, and Passive. Decision-makers select the option that best aligns with their expectations based on their self-assessment.
The Satisfaction with Decision Scale,SWD
The scale consists of 6 items, allowing decision-makers to select the hospital description that best aligns with their individual circumstances.
Decision Regret Scale,DRS
The scale consists of 5 items rated using a Likert 5-point rating scale, with responses ranging from "Strongly Agree" to "Strongly Disagree" assigned scores of 1 to 5 respectively. Items 2 and 4 are reverse-coded. The total score is calculated by converting the mean score of all items using the formula: Total Score = (Mean Score - 1) × 5 This results in a total score range of 0-20 points, where higher scores indicate greater decision regret
Locations
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