NCT07252089

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shiwen Hong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Diabetic Foot Disease

Interventions

Type	Name	Description
PROCEDURE	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 decision-making aid will remain confidential and accessible only to the intervention group, with restricted access for physicians and non-intervention patients.
PROCEDURE	Routine Clinical Consultation and Nursing Care	Patients received routine clinical consultation and nursing care before and after random assignment.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-10-01
• Completion: 2026-10-31
• First posted: 2025-11-26
• Last updated: 2025-11-26