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临床试验/NCT03909802
NCT03909802已完成不适用

Effect of Self- and Family Management of Diabetic Foot Ulcers Programs on Health Outcomes Among Individuals With Diabetic Foot Ulcers in Indonesia

Universitas Muhammadiyah Yogyakarta2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
HbA1c

研究概览

简要总结

Brief description:

Diabetic foot ulcer (DFU) is described as a full-thickness lesion appearing at the skin of the foot along with infection, destruction of tissues due to neuropathy and/or peripheral artery disease (PAD) in people with diabetes (International Working Group on the Diabetic Foot, 2015). DFU commonly develops in middle-aged diabetic patients due to a long period of type 2 diabetes and poor adherence to control blood glucose level (Madanchi et al., 2013). Prevalence of DFU was four times higher than all combined cases of cancers in the world (Boulton, 2013; McInnes, 2012; Shaw, Sicree, & Zimmet, 2010). Numerous published studies have documented the rate of DFU at around 25% in Western Population (Boulton, 2013). Prevalence of DFU was stated between 7.3 % - 24 % at Indonesia hospitals (Soewondo, Ferrario, & Tahapary, 2013). An Indonesia nursing study recorded 12 % of diabetic foot ulcer cases from 249 individuals with type 2 diabetes in a regional hospital of Eastern Indonesia (Yusuf et al., 2015). Cases of infected DFU occurred in 98 patients in Sardjito Hospital Yogyakarta Indonesia in 2016 (Longdong, 2016).

In order to diminish the wide-reaching impact of DFU, a number of efforts have been performed in Indonesia. A study documented that sufficient diabetic patients' knowledge in performing foot care is able to decrease the incidence of DFU as well as LEA (Wulandini, Saputra, & Basri, 2013). Foot ulcers health education program was interrelated with patients' knowledge as well as attitudes concerning responsibility and involvement in DFU care (Arianti, Yetti, & Nasution, 2012; Mahfud, 2012; Sa'adah, Primanda, & Wardaningsih, 2016; Yoyoh, Mutaqqin, & Nurjanah, 2016). In line with their findings, another study confirmed that intensive health promotion increased patients' knowledge and practice in regard to perform routine foot care (Abbas, 2013). Also, health promotion intervention improves Hemoglobin A1c (HbA1c) in type 2 Diabetes (Brown, 1990; Norris, Lau, Smith, Schmid, & Engelgau, 2002; Florkowski, 2013). However, a number of these studies merely focused on the patient, not engaged family members as it may potentially reduce the effectiveness of therapy.

Accordingly, DFU is currently being a critical problems needs to be solved in Indonesia. Ensuring the engagement of both the patients and their families in treatment is an important strategy to deal with the chronic conditions (Baig, Benitez, Quinn, & Burnet, 2015; Miller & DiMatteo, 2013; Pamungkas, Chamroonsawasdi, & Vatanasomboon, 2017). Therefore, conducting a comprehensive intervention of DFU partnering individuals and their families in association with self-and family management is a groundbreaking and challenging strategy to overcome problems on DFU. We believe the findings of our study will render significant contributions to the national guideline of diabetes in Indonesia and prevention of LEA in nursing practice. Furthermore, it will be able to give promising results for accelerating DFU healing.

Purposes of the study:

The purpose of this study is to investigate the effect of a self- and family management of DFU programs on health outcomes as follows: behaviors (adherence to physical activities, medications, diet, foot care, and blood glucose control), family supports, biomarkers (HbA1c, wound size) in patients suffering DFU in Indonesia.

Hypothesis:

The study participants who joined completely the self- and family management of diabetic foot ulcer programs during three months would have a better behavior, biomarkers, and family supports than those who received the usual care.

详细描述

Study background:

Diabetic foot ulcer (DFU) is described as a full-thickness lesion appearing at the skin of the foot along with infection, destruction of tissues due to neuropathy and/or peripheral artery disease (PAD) in people with diabetes (International Working Group on the Diabetic Foot, 2015). DFU commonly develops in middle-aged diabetic patients due to a long period of type 2 diabetes and poor adherence to control blood glucose level (Madanchi et al., 2013). Prevalence of DFU was four times higher than all combined cases of cancers in the world (Boulton, 2013; McInnes, 2012; Shaw, Sicree, & Zimmet, 2010). Numerous published studies have documented the rate of DFU at around 25% in Western Population (Boulton, 2013). Prevalence of DFU was stated between 7.3 % - 24 % at Indonesia hospitals (Soewondo, Ferrario, & Tahapary, 2013). An Indonesia nursing study recorded 12 % of diabetic foot ulcer cases from 249 individuals with type 2 diabetes in a regional hospital of Eastern Indonesia (Yusuf et al., 2015). Cases of infected DFU occurred in 98 patients in Sardjito Hospital Yogyakarta Indonesia in 2016 (Longdong, 2016).

In long-term conditions, DFU leads to lower extremity amputation (LEA) (Pemayun, Naibaho, Novitasari, Amin, & Minuljo, 2016). Several factors relating to LEA were ischemia, neuropathy, end-stage renal disease, and depth of the wound along with infection (Widatalla, Mahadi, Shawer, Elsayem, & Ahmed, 2009). The incidence of LEA was forecasted to be more than a million per year (Peter-Riesch, 2016; Wu, Driver, Wrobel, & Armstrong, 2007). Two studies exposed that amputation procedures were performed every 20 seconds in the diabetic population in the world (Fejfarová et al., 2014). A recent study found the estimated range of amputations around 15 - 32 % in Indonesia (Soewondo et al., 2017). As a consequence, this condition will directly impact on the patient's health-related quality of life that encompasses physical, social, economic, and psychological aspects (Vileikyte, 2001).

In order to diminish the wide-reaching impact of DFU, a number of efforts have been performed in Indonesia. A study documented that sufficient diabetic patients' knowledge in performing foot care is able to decrease the incidence of DFU as well as LEA (Wulandini, Saputra, & Basri, 2013). Foot ulcers health education program was interrelated with patients' knowledge as well as attitudes concerning responsibility and involvement in DFU care (Arianti, Yetti, & Nasution, 2012; Mahfud, 2012; Sa'adah, Primanda, & Wardaningsih, 2016; Yoyoh, Mutaqqin, & Nurjanah, 2016). In line with their findings, another study confirmed that intensive health promotion increased patients' knowledge and practice in regard to perform routine foot care (Abbas, 2013). Also, health promotion intervention improves Hemoglobin A1c (HbA1c) in type 2 Diabetes (Brown, 1990; Norris, Lau, Smith, Schmid, & Engelgau, 2002; Florkowski, 2013). However, a number of these studies merely focused on the patient, not engaged family members as it may potentially reduce the effectiveness of therapy.

Currently, poor adherence to DFU treatment is taken into consideration on the diabetes population in Indonesia. Many diabetic patients had poor adherence in maintaining diabetes treatment which potentially leads to suboptimal diabetes outcomes involving increased blood glucose level, more hospital admissions, diabetes-related complications, and multiplied medical care costs (Putri, Yudianto, Kurniawan, & Titis, 2013; Waluya, 2008). To overcome this issue, intensive health promotion has been considered as the first-line approach in Indonesia (Windasari, 2014). In addition, strategies addressing poor adherence must be focused on reducing DFU complications in the future. This could be successfully achieved by incorporating family members in a particular intervention. A systematic review also pointed out that family support in a given treatment strengthens patient adherence to diabetes treatment (Rintala, Jaatinen, Paavilainen, & Astedt-Kurki, 2013). Efforts have been performed in Indonesia, even though it has some limitations. For instance, some studies merely addressed the age, gender, duration of diabetes and level of patient' education relating to the adherence, not focused on patients' motivation which is presently being the main problem in Indonesia (Ainni, 2017; Srikartika, Cahya, & Hardiati, 2016). Also, providing care to those suffering diabetes potentially becomes a burden on both physical and emotional aspects. Also, some individuals reported that they felt sadness when their family does not fully support their care. In line with these findings that, negative family support is the robust predictor for the patient's stress and decreased diabetes outcome (Pardamean & Dharmady, 2003; Isworo, Ekowati, Iskandar, & Latifah, 2018). The other study stated that patients receiving non-supportive care from a family member are more likely to have a poor blood glucose level (Isworo & Saryono, 2010). Moreover, the lack of family knowledge, low levels of self-efficacy, and insufficient social support from family members lead to poor diabetes self-management (Pamungkas, Chamroonsawasdi, & Vatanasomboon, 2017).

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

The participants are masked from knowing the intervention given.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

HbA1c

时间窗: up to 3 months

Hemoglobin A1c (HbA1c) is defined as the glycated hemoglobin level that reflects the index of glycemia over 2-3 months. It is frequently used to examine glycemia in a patient with chronic diabetes. HbA1c will be measured by using a laboratory test examination certified by ISO 9001: 2015. After study accomplished, the expected goal of the HbA1c is less than 7 % as per recommendation by American Diabetes Association and Persatuan Endokrinologi Indonesia (American Diabetes Association, 2018; Persatuan Endokrinologi Indonesia, 2015). The measurement of this variable would be performed by a laboratory analyst.

Wound size

时间窗: up to 3 months

Wound size is defined as lesions of foot ulcers that can be quantitatively evaluated and categorized according to their length, width, and depth. In this study, wound size will be assessed throughout the study by implementing the photographic method as the gold standard measurement (Shetty et al., 2012). The PEDIS system will be used as a recommended classification (Game, 2016). This classification assesses perfusion (ischemia), extent (area), depth, infection, sensation (neuropathy). Individuals who have scored at \< 7 is categorized at the low risk of the non-healing wound. Those who have \> 7 are categorized at the high risk of a non-healing wound, amputation, and death (Chuan, Tang, Jiang, Zhou, \& He, 2015). The stage of the wound would be assessed by a research assistant who is a certified wound care nurse.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumarno Adi Subrata, PhD (Candidate)

Principal investigator

Universitas Muhammadiyah Yogyakarta

研究点 (2)

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