Effect of Self- and Family Management of Diabetic Foot Ulcers Programs on Health Outcomes

NCT03909802 | Completed DMC

• 1 other identifier: PRJ-2973 /LPDP.3/2016
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabete Mellitus; Diabetic Foot

Outcome Measures

Primary Outcomes (2)

• HbA1c

  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.

  up to 3 months

• Wound size

  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.

  up to 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

This arm will receive interventions consisting of self-management combined with family management programs.

Behavioral: Self-and family management of diabetic foot ulcers programs

Control group

PLACEBO COMPARATOR

Usual care refers to incorporating wound assessment, wound irrigation using NaCl, debridement, wound dressing, evaluation, and health education unmet with the self-and-family management of DFU program criteria in this study. All of the usual care will be performed and evaluated by the wound care nurses working at the selected clinics for this study.

Other: Usual care

Interventions

Self-and family management of diabetic foot ulcers programs BEHAVIORAL

The intervention combines self-management and family management focusing on behavioral changes in patients with diabetic foot ulcers. Self-management focuses on intensive health education of physical activities, diet, medication, foot care, and blood glucose control. Family management focuses on problem-solving, establishing roles, and effective involvement in providing care amid individuals suffering DFU.

Experimental group

Usual care OTHER

Usual care

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual both men and women who were diagnosed stage 2 and more of DFU by certified wound care nurses.
• Individual having DFU located on the one or two legs.
• An individual who either regularly or not regularly visits the selected wound care clinics.
• Individual not in the fasting period either in Ramadan or another occasion.
• An individual who able to read and communicate in Indonesia language.

You may not qualify if:

• Individual who is hospitalized due to the complexities of diabetes.
• Individual who at the end of life care.
• Individual who is currently having any critical condition which potentially interferes data collection processes such as acute diabetic ketoacidosis and impaired consciousness.
• An individual who has blindness due to diabetes or aging.
• The individual is the caregiver or family members of an individual having DFU.
• An individual who able to read and communicate in Indonesia language.
• Individuals who attend the program less than 80 percent due to getting sick or other reasons.
• Termination criteria:
• This study will be suspended or terminated some or all research activities if events are identified representing serious or continuing noncompliance or unanticipated health issues involving risk to subjects or others related to DFU complications.

Sponsors & Collaborators

• Universitas Muhammadiyah Yogyakarta: lead

Study Sites (1)

Faculty of Health Sciences, Universitas Muhammadiyah Magelang

Magelang, Central Java, 56172, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are masked from knowing the intervention given.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The researcher will assess the obtained information relating to the patient having DFU and make a list of potentially eligible participants. Those who met the criteria will be random using research randomizer application. The participants will be provided an information sheet in the course of study objectives. Also, this objective will be informed to the owner of wound care clinics for improving the current treatment. Afterward, those who have a willingness to take part in this study will be interviewed to re-assess the eligible inclusion criteria. If they met with the criteria, they will be asked to sign informed consent, provide their home address and a convenient phone number as well. Prior to the study implementation, each eligible participant will be randomly assigned to determine whether he or she will be included either into an experimental or control group. This process will utilize a research randomizer application and the result will be protected by the researcher only.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: July 6, 2019
• Primary Completion: November 29, 2019
• Study Completion: December 10, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)