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.
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).
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.
Parallel
Gain-Framed
BehavioralParticipants 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.
Loss-Framed
BehavioralParticipants 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.
Routine Care
BehavioralParticipants 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.
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.
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.
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 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
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.
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.
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.
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