Impact of Educational Interventions on Diabetic Foot Self-care: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- General foot health
研究概览
简要总结
Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients.
This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care - Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls, after obtaining the patients' consent.
The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.
详细描述
Specific Aims
- To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time.
- To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health.
- To examine the mediating role of representations about diabetic foot in the relationship between knowledge about foot care and adherence to diabetic foot care, over time, controlling for health literacy.
- To examine the moderating role of foot pain, foot function, and footwear between representations about diabetic foot and adherence to diabetic foot care/ perceived foot health, over time.
Data Analysis:
Generalized Mixed Models, which allow examining changes over time including longitudinal mediation and moderation.
Sample size calculation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Randomisation will be performed through an online random number generator, by a researcher external to the team of this study, to ensure the concealment of the allocation of participants by the several groups (Pandis, 2012). It will not be possible to conceal the group to which the patient was allocated to the medical and nursing team, since they have to administer the intervention or the researcher who will have to inform the respective team and administer the intervention in the Reading Group. Only the participants will be blind to the group to which they have been allocated.
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
- •Diagnosis of Diabetes mellitus;
- •Diagnosis of Diabetic Foot;
- •To benefit from the first assessment and follow-up at the Multidisciplinary Diabetic Foot Consultation of the hospitals where data collection will take place.
排除标准
- •Presence of clinical dementia described in the patient's clinical record;
- •Cognitive disability to answer the questionnaires;
- •Severe visual and/or hearing impairment.
结局指标
主要结局
General foot health
时间窗: Changes from baseline to two weeks post-test and after a three month follow-up
General foot health will be assessed through the respective subscale of the Foot Health Status Questionnaire (FHSQ; Bennett, Patterson, Wearing, \& Baglioni, 1998). Scores are transformed into a scale of 0 to 100, where 0 corresponds to the perception of poor foot health state/condition and 100 to the perception of excellent foot health.
Knowledge on foot care
时间窗: Changes from baseline to two weeks post-test and after a three month follow-up
Knowledge on foot care will be assessed through the Questionnaire on Knowledge of Foot Care (Hasnain \& Sheikh, 2009). Each correct answer is scored with 1 point and higher scores indicate better knowledge about foot care.
Adherence to the diabetic foot care behaviours
时间窗: Changes from baseline to two weeks post-test and after a three month follow-up
Adherence to foot care behaviors will be assessed through the Nottingham Assessment of Functional Foot Care (Lincoln, Jeffcoate, Ince, Smith, \& Radford, 2007). Composed of 29 items whose answers are given on a Likert scale ranging from 0 to 3. Higher scores correspond to a higher frequency of foot care behaviors.
次要结局
- Representations about diabetic foot(Changes from baseline to two weeks post-test and after a three month follow-up)
研究者
Gabriela Ferreira
Principal Investigator, Master
University of Minho