Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- Foot ulceration
研究概览
简要总结
This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration.
Design: Physician-blinded, randomized, 18-month trial.
Setting: Diabetes outpatient clinics from two public hospitals
Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot, (5) have an operating cell phone or a caregiver with an operating cell phone, and (6) have the ability to provide informed consent.
Hypothesis: The investigators hypothesize that implementation of an enhanced intervention that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS and voice messaging will improve patient measurement compliance and reduce diabetic foot ulcers in a middle income country.
详细描述
Detailed Description:
Thermometry is a promising emerging modality for the prevention of diabetic foot ulcers according to different clinical trials. However, patient compliance with self-monitoring temperature at home is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, the investigators propose to determine the utility of SMS and voice messaging to remind the patients to perform the thermometry, and to assess the impact on diabetic foot ulceration.
Specific Aims are:
- Compare the incidence of diabetic foot ulceration during the study between the arm that receives thermometry alone and the arm that receives thermometry plus SMS and voice messaging.
- Compare the compliance with foot thermometer use between the two study arms.
- Compare the frequency of alarms signs reported to the study nurse in the two study arms.
- Compare the frequency of alarms signs reported in the patient's logbooks in the two study arms.
- Compare the incidence of diabetic foot ulceration according to pre-specified sub-groups: caregiving status, and use of insoles and/or orthopedic shoes.
- In the intervention-only group, compare the incidence of diabetic foot ulcers by varying the recipient of the messaging intervention (patient vs caregivers).
Intervention:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus.
- •Dorsalis pedis pulse in both feet.
- •In risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot.
- •Operating cell phone or a caregiver with an operating cell phone.
- •Ability to provide informed consent.
排除标准
- •Current ulcers or open amputation sites.
- •Active osteoarthropathy
- •Severe peripheral vascular disease
- •Foot infection
研究组 & 干预措施
Thermometry-only group
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet.
Some alarm signs have been pre-specified: 1) thermal image shows yellow spots in any area of feet for two consecutive days, 2) thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone. (See Detailed Description for more detail on the actions after an alarm sign has been observed)
干预措施: Thermometry (Device)
Thermometry plus SMS and voice messaging
Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both SMS and voice messaging.
During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).
干预措施: SMS and voice messaging (Behavioral)
Thermometry plus SMS and voice messaging
Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both SMS and voice messaging.
During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).
干预措施: Thermometry (Device)
结局指标
主要结局
Foot ulceration
时间窗: 18 months
The primary outcome is foot ulceration occurring at any point during the 12 month study duration. Foot ulceration will be defined using the American Diabetes Association criteria, which defines ulcers as any break in the cutaneous barrier; that usually extend through the full thickness of the dermis. There will be two ways of identifying if a patient has developed foot ulceration: (1) during the clinical evaluations done by a nurse every 2 months. (2) In addition to these bimonthly assessments, patients will be advised to make telephone calls to the study's nurse to report the presence of an ulcer, and he/she will be asked to go to the hospital for a face-to-face evaluation to be conducted by a masked nurse.
次要结局
- Adherence to daily temperature measurement(18 months)
- Report of an alarm sign to the nurse(18 months)
- Report of an alarm sign in the logbook(18 months)
- Dose-response analysis of SMS and voice messaging(18 months)
- Glycosilated hemoglobin control targets(18 months)
研究者
Jaime Miranda
PhD
Universidad Peruana Cayetano Heredia