Risk Perception Intervention for High-Risk Diabetic Foot

NCT07581262 | Not Yet Recruiting

• 1 other identifier: （2026）Teaching No.018
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

diabetes mellitus; high risk foot; diabetic foot ulcer; risk perception

Outcome Measures

Primary Outcomes (1)

• foot ulcer risk perception score

  Assessed using the Chinese version of the Tripartite Model of Risk Perception (TRIRISK) Scale, developed by Ferrer et al. in 2016. The scale consists of 18 items across 3 dimensions: rational perception, emotional perception, and experience perception. A Likert 7-point scoring method (1-7 points) is used. Higher scores indicate a higher individual perception of diabetic foot ulcer risk.

  Baseline, at the end of intervention (week 4), and at 1 and 3 months post-intervention.

Secondary Outcomes (6)

• Foot care behavior score

  Baseline, at the end of intervention (week 4), and at 1 and 3 months post-intervention

• Diabetes self-efficacy score

  Baseline, at the end of intervention (week 4), and at 1 and 3 months post-intervention.

• Baseline Demographic and Clinical Characteristics

  Baseline (T0)

• Medical Help-seeking Delay Intention score

  Baseline (T0), at the end of intervention (T1), and at 1 month (T2) and 3 months (T3) post-intervention.

• Glycemic Control Indicators

  HbA1c will be measured at baseline (T0) and 3 months post-intervention (T3).

Other Outcomes (2)

• laboratory index

  Baseline (T0) and 3 months post-intervention (T3).

• DFU Incidence and Recurrence.

  From baseline through the 3-month follow-up.

Study Arms (3)

Experimental Group 1: Gain-Framed

EXPERIMENTAL

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: Gain-Framed

Experimental Group 2: Loss-Framed

EXPERIMENTAL

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: Loss-Framed

Control Group: Routine Care

ACTIVE COMPARATOR

Participants will receive standard, neutral health education regarding diabetic foot care without any specific information framing. They will receive standard, neutral endocrinology department routine care without any specific information framework.

Behavioral: Routine Care

Interventions

Gain-Framed BEHAVIORAL

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.

Experimental Group 1: Gain-Framed

Loss-Framed BEHAVIORAL

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.

Experimental Group 2: Loss-Framed

Routine Care BEHAVIORAL

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.

Control Group: Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old with good communication and cognitive abilities.
• Meet the World Health Organization (WHO) diagnostic criteria for Type 1 or Type 2 Diabetes Mellitus.
• Meet the diagnostic criteria for high-risk diabetic foot according to the International Working Group on the Diabetic Foot (IWGDF) 2023 standards.
• Proficient in the use of a smartphone and related applications (e.g., WeChat).
• Voluntarily participate in the study and provide signed informed consent.

You may not qualify if:

• Patients with impaired consciousness, severe organ dysfunction, or other physical disabilities that lead to being bedbound or unable to perform foot care.
• Patients with peripheral neuropathy caused by non-diabetic factors (e.g., toxic, nutritional, or hereditary neuropathies).
• Patients with gestational diabetes or those with pre-existing diabetes who are currently pregnant.

Sponsors & Collaborators

• The Third Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Central Study Contacts

Chumin Zhang, Bachelor (Master student)

CONTACT

86-15995777278; cmviki@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts are also blinded to the group assignments during the data analysis process.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nurse,Deputy Director of Nursing Department

Model Details: This study is a three-arm parallel randomized controlled trial

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share