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

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ClinicalTrials.gov Identifier: NCT03909802
Recruitment Status : Active, not recruiting
First Posted : April 10, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sumarno Adi Subrata, PhD (Candidate), Universitas Muhammadiyah

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.


Condition or disease Intervention/treatment Phase
Diabete Mellitus Diabetic Foot Behavioral: Self-and family management of diabetic foot ulcers programs Other: Usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: The participants are masked from knowing the intervention given.
Primary Purpose: Prevention
Official Title: Effect of Self- and Family Management of Diabetic Foot Ulcers Programs on Health Outcomes Among Individuals With Diabetic Foot Ulcers in Indonesia
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : December 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
This arm will receive interventions consisting of self-management combined with family management programs.
Behavioral: Self-and family management of diabetic foot ulcers programs
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.

Placebo Comparator: Control group
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
Usual care




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 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.

  2. Wound size [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Individual inclusion criteria:

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

Individual exclusion criteria:

  1. Individual who is hospitalized due to the complexities of diabetes.
  2. Individual who at the end of life care.
  3. Individual who is currently having any critical condition which potentially interferes data collection processes such as acute diabetic ketoacidosis and impaired consciousness.
  4. An individual who has blindness due to diabetes or aging.

Family inclusion criteria:

  1. The individual is the caregiver or family members of an individual having DFU.
  2. An individual who able to read and communicate in Indonesia language.

Family exclusion criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909802


Locations
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Indonesia
Faculty of Health Sciences, Universitas Muhammadiyah Magelang
Magelang, Central Java, Indonesia, 56172
Sponsors and Collaborators
Universitas Muhammadiyah

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Responsible Party: Sumarno Adi Subrata, PhD (Candidate), Principal investigator, Universitas Muhammadiyah
ClinicalTrials.gov Identifier: NCT03909802     History of Changes
Other Study ID Numbers: PRJ-2973 /LPDP.3/2016
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Glucose Metabolism Disorders
Metabolic Diseases