Risk Perception Intervention for High-Risk Diabetic Foot

Summary

This study aims to evaluate the effect of health education based on information framing effects on foot ulcer risk perception in patients at high risk of diabetic foot.

Study Design:

A randomized controlled trial with three groups:

Experimental Group 1 (Gain-Framed): Participants received a benefit framing message that emphasized the benefits of standardized foot care in reducing the likelihood and severity of foot ulcers, with an aim to reshape patients' perception of risk.

Experimental Group 2 (Loss-Framed):Participants received a loss frame message that emphasized that neglecting foot care would increase the likelihood and severity of foot ulcers. The message was designed to awaken patients' awareness of crisis and risk perception.

Control Group (Routine Messaging):Participants received the usual content of care in the endocrinology department without a specific framework.

Participants:

Diabetic foot patients at high risk from experimental group 1, experimental group 2, and control group 3. Inclusion criteria included adults with a diagnosis of diabetic foot at high risk.

Intervention:

The Total Study Period consisted of an intervention phase and a follow-up phase. The intervention phase started at the time of enrollment and lasted until the fourth week after discharge. The follow-up period lasted for 3 months. Data on local indicators were collected at baseline/before the intervention (T0), immediately after the intervention (T1), 1 month after the intervention (T2) and 3 months after the intervention (T3).

Outcome Measures:

Primary Outcomes:

Foot ulcer risk perception: Assessed using The Tripartite Model of Risk Perception Scale.

Secondary Outcomes:

Foot care behavior score: Assessed using The Nottingham Foot Care Assessment Scale; Self-efficacy: Assessed using The Diabetes Self-Efficacy Scale; Intention to delay seeking medical help score:Assessed using the Questionnaire on Intention to Delay Seeking Medical Care for Patients with High-Risk Diabetic Foot; the incidence/recurrence rate of foot ulcers, and various laboratory indicators.

Conditions

• Diabetes Mellitus
• Diabetic Foot Ulcer (DFU)
• Risk Perception
• Peripheral Neuropathy With Type 2 Diabetes

Interventions

BEHAVIORAL

Gain-Framed

Participants will receive a gain-framed health education intervention starting during hospitalization and continuing for 4 weeks post-discharge via WeChat. They will be provided with a gain-framed "High-Risk Foot Protection Manual," educational videos, and peer success stories. For example, a message will state: "Mastering proper foot care helps establish an external protective barrier for your feet, effectively preventing 50% of foot ulcers and maintaining your independent mobility." Participants will also submit foot care photo check-ins via WeChat, receiving gain-framed positive reinforcement regarding their healthy habits.

BEHAVIORAL

Loss-Framed

Participants will receive a loss-framed health education intervention following the same methods (face-to-face and WeChat) as Group 1. They will receive a loss-framed manual, videos, and peer warning stories. An example message will state: "Ignoring proper foot care routines can cause minor wounds to rapidly deteriorate into deep infections, leading to a 19% risk of amputation, loss of mobility, and heavy financial burdens." During their WeChat check-ins, they will receive loss-framed reminders emphasizing the severe risks of neglecting foot care.

BEHAVIORAL

Routine Care

Participants will receive standard, objective health education regarding diabetic foot care without any specific information framing. This includes routine nursing care from the Department of Endocrinology, such as inpatient foot skin assessment, basic hygiene education, and standard hospital discharge guidance. Post-discharge follow-ups will be conducted via telephone or WeChat to monitor recovery and medication adherence according to the hospital's standard protocol.

Sponsors & Collaborators

• The Third Affiliated Hospital of Soochow University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2026-12-31

Completion

2026-12-31