Diabetic Foot Disease
Conditions
Keywords
Diabetic Foot Amputation Decision-Making Aid Tool
Brief 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.
Interventions
PROCEDUREApplications 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.
PROCEDURERoutine Clinical Consultation and Nursing Care
Patients received routine clinical consultation and nursing care before and after random assignment.
Sponsors
Sir Run Run Shaw Hospital
Shiwen Hong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* History of psychiatric disorders with inability to cooperate during communication. Concomitant severe complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale，DCS | When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| The Control Preference Scale，CPS | When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively | 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 | Three days post-surgery ；One month postoperatively | 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 | Three days post-surgery；One month postoperatively | 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 |
Outcome results
None listed