Risk Perception Intervention for High-Risk Diabetic Foot

Construction and Application of a Foot Ulcer Risk Perception Intervention Program for Diabetic Patients With High-risk Foot Based on Information Framework Effect

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Diabetic Foot Ulcer (DFU); Risk Perception; Peripheral Neuropathy With Type 2 Diabetes
• Intervention / Treatment: Behavioral: Gain-Framed; Behavioral: Loss-Framed; Behavioral: Routine Care

Detailed Description

Title: Construction and Application of a Foot Ulcer Risk Perception Intervention Program for Diabetic Patients with High-risk Foot Based on Information Framework Effect.

Study Setting and Population: This study will be conducted at the Department of Endocrinology and Metabolism of a tertiary comprehensive hospital in Changzhou, Jiangsu Province, China. The target population consists of adult patients diagnosed with diabetes mellitus who are identified as having a high-risk diabetic foot.

Study Design and Methodology:

This study is designed as a three-arm randomized controlled trial. Population and Sample: The study population consists of patients with diabetic foot at high risk. The sample will include individuals meeting the inclusion criteria and consenting to participate. Participants will be randomly assigned to one of three groups: Experimental Group 1, Experimental Group 2, and Control Group 3. A three-month intervention will be implemented. Participants will receive a four-week intervention and a three-month follow-up from enrollment to discharge.

Sample Size Calculation: The sample size was estimated using the G*Power program based on a one-way analysis of variance (ANOVA). Referencing a previous study that used risk perception as an outcome indicator, an effect size of 0.54 was applied. With a two-sided significance level of α = 0.05 and a power of 1-β = 0.90, the minimum total sample size was calculated as 48. Considering a 15% dropout rate, the required minimum total sample size was adjusted to 57. Ultimately, the study determined a final total sample size of 90 participants, resulting in 30 participants per group.

Randomization: Participants will be randomly assigned to one of three arms (Gain-framed, Loss-framed, or Control group) in a strict 1:1:1 ratio. The random allocation sequence will be computer-generated by an independent researcher using a mixed block randomization strategy (block sizes of 6 and 9).

Allocation Concealment: Allocation will be strictly concealed using sequentially numbered, opaque, sealed, and tamper-evident envelopes (SNOSE). These envelopes will be prepared by independent personnel and opened sequentially by researchers only after a participant is officially enrolled and just prior to the intervention.

Blinding (Masking): Assessor Blinding: Due to the nature of the behavioral (non-pharmacological) intervention, participants cannot be blinded. However, the study employs strict assessor and data analyst blinding. All primary outcomes will be evaluated by trained nurses who are completely blinded to the group assignments.

Contamination Control: To minimize inter-group contamination, all participants will receive identical-looking health education manuals. Additionally, participants are required to sign confidentiality agreements prohibiting the discussion of their specific intervention details with others.

Intervention Procedure:

Participants in all groups completed baseline assessments (T0) after enrollment (before formal intervention). which include collecting demographic and clinical data, as well as completing the Tripartite Model of Risk Perception (TRIRISK) scale, the Nottingham Assessment of Functional Footcare (NAFF), the Medical Help-Seeking Delay Intention Questionnaire, and the Diabetes Self-Efficacy Scale.

Experimental Group 1 (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.

Experimental Group 2 (Loss-Framed): Participants will receive a loss-framed health education intervention following the same timeline and delivery 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.

Control Group 3 (Routine Care): 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.

At the end of the active intervention phase (T1: 4 weeks post-discharge), and during the follow-up periods at 1 month (T2) and 3 months (T3) post-intervention, the TRIRISK scale, NAFF, Delay Intention Questionnaire, and Diabetes Self-Efficacy Scale will be re-administered, alongside the collection of clinical laboratory indicators and foot ulcer incidence rates.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chumin Zhang, Bachelor (Master student); Phone Number: 86-15995777278; Email: cmviki@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1: 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: 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.
Experimental: Experimental Group 2: 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: 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.
Active Comparator: Control Group: Routine Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot care behavior score	Assessed using the Chinese version of the Nottingham Assessment of Functional Footcare (NAFF), which was translated and validated by Li Jing et al.. The Chinese version contains 24 items across 5 dimensions: foot examination, foot cleaning, foot protection, footwear selection, and health-seeking behavior. Each item is scored on a 0-3 scale, with total scores ranging from 0 to 72. Higher scores indicate better foot self-care behavior.	Baseline, at the end of intervention (week 4), and at 1 and 3 months post-intervention
Diabetes self-efficacy score	Assessed using the Diabetes Self-Efficacy Scale (DSES), originally developed by Hurley and Shea and later translated and modified by Wang et al.. The scale has demonstrated good reliability and validity in Chinese populations, with a test-retest reliability of 0.85 in mainland China.The scale consists of 26 items across 5 dimensions:Diet self-efficacy Exercise self-efficacy Medication self-efficacy Blood glucose monitoring self-efficacy Foot care and prevention/management of high/low blood glucose self-efficacy.Items are scored on a 5-point Likert scale, ranging from 1 ("no confidence at all") to 5 ("complete confidence"). Total scores range from 26 to 130, with higher scores indicating a higher level of diabetes self-efficacy.	Baseline, at the end of intervention (week 4), and at 1 and 3 months post-intervention.
Baseline Demographic and Clinical Characteristics	Assessed using a self-compiled General Information Questionnaire, which consists of two parts:Demographic Data: Includes contact information, gender, age, ethnicity, and educational level.Clinical Data: Includes family history of diabetes, duration of diabetes, medication methods, and presence of diabetes-related complications or foot-related high-risk factors.This information is collected at baseline to describe the study population and evaluate the comparability between groups	Baseline (T0)
Medical Help-seeking Delay Intention score	Assessed using the Medical Help-seeking Delay Intention Questionnaire for Patients with High-risk Diabetic Foot, developed by Xu Liwen et al. in 2018. The questionnaire consists of 7 items, such as "If my foot is injured, it will heal naturally in a few days" and "It's too much trouble to go to the hospital".Each item is scored on a 4-point Likert scale, where "Completely Agree," "Mostly Agree," "Partially Agree," and "Disagree" are scored from 1 to 4 points, respectively. Total scores range from 7 to 28. A higher total score indicates a lower intention to delay seeking medical care among patients with high-risk diabetic feet. The questionnaire has demonstrated good reliability and validity, with a Cronbach's α of 0.884 and a well-fitted single-factor model.	Baseline (T0), at the end of intervention (T1), and at 1 month (T2) and 3 months (T3) post-intervention.
Glycemic Control Indicators	Glycated Hemoglobin (HbA1c) . HbA1c is measured to assess the average blood glucose control over the past 3 months.	HbA1c will be measured at baseline (T0) and 3 months post-intervention (T3).
Glycemic Control Indicators	Randomized Serum Glucose (RSG). RSG is used for immediate glucose status monitoring.	RSG will be measured at baseline, the end of intervention (T1), and at 1 month (T2) and 3 months (T3) post-intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
laboratory index	RSG is used for immediate glucose status monitoring; A comprehensive assessment of peripheral nerve function including vibration perception threshold (VPT): measured using a biothesiometer, pressure sensation: assessed using the 10g Semmes-Weinstein monofilament (SWM) test, electromyography (EMG) and nerve conduction velocity (NCV): to evaluate the speed and strength of nerve signals.	Baseline (T0) and 3 months post-intervention (T3).
DFU Incidence and Recurrence.	To exploratorily monitor the clinical impact of the intervention, the incidence of new-onset diabetic foot ulcers (among participants with no prior history) and the recurrence rate (among those with a prior history) will be recorded. Due to the limited 3-month follow-up period, these are pre-specified as exploratory safety and clinical monitoring indicators.	From baseline through the 3-month follow-up.

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: diabetes mellitus; diabetic foot ulcer; risk perception; high risk foot
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Diabetic Foot
• Other Study ID Numbers: （2026）Teaching No.018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The dataset contains sensitive clinical information and there is currently no formal plan for public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No