Construction and Application of a Foot Ulcer Risk Perception Intervention Program for Diabetic Patients With High-risk Foot Based on Information Framework Effect
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts are also blinded to the group assignments during the data analysis process.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Yun Ye
Associate Chief Nurse,Deputy Director of Nursing Department
The Third Affiliated Hospital of Soochow University