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.
