Effectiveness of a Theory-Based Foot Care Education Program on Self-Efficacy and Adaptation in Patients With Diabetes in Turkey: A Randomized Controlled Trial

Diabetes mellitus is characterized by hyperglycemia, glycosuria, and many accompanying clinical and biochemical findings resulting from insufficiency, absence, and/or deficiency of insulin. It negatively affects quality of life by causing complication-related organ and functional losses.¹ It is estimated that by 2030, there will be over 643 million people with diabetes worldwide.² In a recent study, the prevalence of diabetes in Turkey was found to be 11.12%.³ Diabetes and its complications are swiftly developing into the leading causes of morbidity and mortality worldwide.⁴ With the rising number of individuals with diabetes globally, health care practitioners are advised to pay close attention to the key complications of diabetes in their regular practice.⁵ Diabetic foot disease—which is caused primarily by neuropathy, peripheral arterial disease, and/or infection—frequently results in ulceration and limb amputation. It is among the most expensive complications of diabetes and can have a significant economic, social, and public health impact, particularly in low-income communities with no appropriate educational program.⁶ With foot ulcers occurring in up to 25% of patients with diabetes, much more attention must be paid to the diabetic foot, and the emphasis must shift from treating ulcers to preventing them.⁷

In the past several years, much research has been done on patient education to prevent foot complications in patients with diabetes. Foot amputations have been reduced by 85% because of prevention, excellent patient education, sensitivity and education of health care professionals, multifaceted foot ulcer treatment, and regular follow-up.^8-10 Experimental outcomes studies evaluating patient education in individuals with diabetes show that such education reduces the risk of diabetic foot by 49% to 85%.¹⁰ These findings support the belief that foot self-care knowledge and patient behaviors improve with education and that such education is effective in reducing the rate of foot ulcers and amputation, especially in high-risk patients.¹¹ Currently, education is an important aspect of a comprehensive strategy to prevent diabetic foot that may reduce foot complications and amputations by up to 85%.¹² International guidelines emphasize the importance of reducing the occurrence of foot ulcers through preventive measures.¹³ This includes not only better metabolic management and identification and screening of people at high risk of diabetic foot ulcers, but also patient education to encourage self-examination and foot care awareness.¹⁴

Models and theories in nursing, which are an important element of scientific knowledge in the field, provide direction at every stage of the nursing process. Such theories and models help contextualize the collected data about the individual and aid in the design and assessment of interventions.¹⁵ Despite growing interest in models and theories, models are rarely used in nursing practice. Most of the models have complex structures and are composed of abstract concepts.¹⁶ Nursing models are used to direct nursing care. Nurses benefit from this guidance because it offers them a way of thinking about foot care. Nursing theories help to ensure that nursing care is systematic, controlled, and efficient.^15,17

The strength of the Roy Adaptation Model is that it can provide reinforcement to individuals in non-nursing professions such as health educators and others who do not typically receive formal training in clinical health sciences.¹⁸ The Roy Adaptation Model framework is highly suited to guiding nurses’ education. Adaptive behaviors such as lifestyle adjustments are critical in diabetes management. In persons with diabetes, a well-balanced diet and increased physical activity can help lower the risk of problems and maladaptation. Through adaptive behaviors, diabetes can be managed, its complications avoided, and patient quality of life improved. The Roy Adaptation Model can be applied to assist patients in adapting healthy behaviors, even for patients with incurable diseases.¹⁹

Self-efficacy is one component of Albert Bandura’s Social Cognitive Theory. The use of demonstration in diabetic foot care training is advocated in Bandura’s Social Cognitive Theory. Demonstrating foot care provides patients both active mastery and vicarious experience, which can promote self-efficacy in foot care activities. According to Bandura, people learn through observation because of the effects of imitation.²⁰ The modeling effect, which involves the acquisition of novel responses, can be used in learning foot care behaviors when nurses demonstrate foot care and patients respond with a foot care demonstration. In addition, verbal persuasion from health care providers can influence foot care behaviors.²¹

Historically, most studies on diabetic foot care in Turkey have been conducted to determine the general situation rather than focusing on specific issues such as preventive measures, treatment options, and patient education. Studies show that persons with diabetes have significant problems with their feet because of inadequate foot care. Some health care providers have proposed that foot care training programs would be beneficial for these patients. However, as of the time of this writing, there was no study in Turkey on planned training programs in which 2 nursing models were used to meet the foot care needs of patients with diabetes.^22,23

The present study was guided by the Roy Adaptation Model and Social Cognitive Learning Theory. The conceptual-theoretical-experimental structure of the Roy Adaptation Model described by Jennings¹⁸ and of Bandura’s Social Cognitive Theory²⁰ are shown in Supplemental Figure 1 and Supplemental Figure 2, respectively. The training provided is based on the Roy Adaptation Model and Social Cognitive Learning Theory (Table 1).

Hypotheses

H1: Education and follow-up based on Social Cognitive Learning Theory and the Roy Adaptation Model have an effect on increasing diabetic foot care self-efficacy.

H2: Education and follow-up based on Social Cognitive Learning Theory and the Roy Adaptation Model have an effect on increasing foot care behaviors.

H3: Education and follow-up based on Social Cognitive Learning Theory and the Roy Adaptation Model have an effect on increasing adaptation.

Aims. The research was carried out to examine the effects of diabetic foot training on self-efficacy and adaptation based on Social Learning Theory and the Roy Adaptation Model.

Participants. The study included individuals with diabetes who received care at the endocrine polyclinic at İzmir Ataturk Training and Research Hospital in İzmir, Turkey, from November 2019 through July 2020. The sampling inclusion criteria were as follows: conscious patient, no verbal communication barrier, able to read and write, aged 18 years or older, diagnosis of over 1 year’s duration, type 1 or type 2 diabetes, no diabetic foot wounds, resident of İzmir province, and voluntary agreement to participate in the research (Figure 1).

Sample. The sample size was calculated with the support of a statistical consultant. Power analysis was performed. To determine a 50% effect size with 85% power and a 0.05 margin of error, the minimum number of participants required in each group was determined to be 45. After the first month of training given to the intervention group, 2 people left the study voluntarily. At 6-month follow-up, 3 people in the intervention group and 5 people in the control group did not want to go to the hospital owing to the pandemic and left the study. The study was completed by 80 people, with 40 each randomized to the intervention group and the control group.

Randomization and allocation. The randomization process for the intervention and control groups was carried out in consultation with a statistics expert. Individuals who met the research criteria were referred to the researcher by an independent research assistant who was not involved in the research. After individuals provided informed consent to participate, the researcher divided the individuals into the intervention and control groups according to a computer-based randomization list.

Data collection tools.

Patient identification form. The 2-part patient identification form was prepared by the authors of the present study in accordance with the relevant literature.^8-10,24 The first part consiste of 8 questions, including questions about patients’ sociodemographic characteristics, such as age, sex, occupation, education, marital status, employment status, place of residence, smoking, and alcohol use. The second part had a total of 7 questions about diabetes, including diabetes type, diabetes duration, whether the person received training on diabetic foot care, medications used in diabetes management, the presence of diabetic complications, type of complications, prior history of foot ulcer, and previous examination of the foot for diabetes.

Metabolic variables form. Metabolic control values such as hemoglobin A_1c, preprandial and postprandial blood glucose, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglyceride, alanine aminotransferase, aspartate aminotransferase, urea nitrogen, albumin, creatinine, and body mass index were examined in the sample group. The reference value for the diagnosis of diabetes and its complications by the Turkish Society of Endocrinology and Metabolism is taken from the treatment and following instructions.²⁵

Diabetic foot risk assessment form. A risk diagnosis form prepared by the Registered Nurses’ Association of Ontario was used to reduce foot ulcers in patients with diabetes and to support evidence-based practices.²⁶ The Nursing Best Practice Guideline was created in 2004 and revised in 2007. The evaluation criteria include prior history of foot ulcers, loss of protective sensation, structural or biomedical disorders in the foot, evaluation of circulation, foot self-care knowledge, and foot self-care behavior. This form can be used for all individuals with diabetes aged 15 years or older.

Diabetic Foot Evaluation Form. Physical examination of the foot was performed using the Diabetic Foot Evaluation Form developed by the Diabetes Nursing Association in Turkey.²⁷ Items on this form include heat, hydration, edema, and color status of the fingertips, foot, body, and lower extremities; presence of dorsalis pedis and tibialis posterior pulses; nail cutting; examination between fingers; presence of claw toe; foot sensation test; ankle-brachial index; muscle strength; deformities; and shoe evaluation. Quantitative somatosensory threshold tests should be applied when evaluating the neurological status of the foot; in the present study, such testing was done using the 5.07 Semmes-Weistein 10-g monofilament.²⁷

Diabetic Foot Care Self-Efficacy Scale. The Diabetic Foot Care Self-Efficacy Scale was developed by Bonnie Elliott Quarles to determine the perception of patients with diabetes themselves of their own power in performing diabetic foot care activities. Quarles reported a Cronbach α value of 0.94.²⁸ Biçer and Enç²² tested the Turkish validity and reliability of the scale and reported the Cronbach α value to be 0.86. In the present study, the Cronbach α value was 0.88.

Nottingham Assessment of Functional Footcare. The Nottingham Assessment of Functional Footcare developed by Lincon et al²⁹ is used to evaluate the foot care practices of individuals with diabetes. Akyol and Özdemir³⁰ performed a Turkish validity and reliability study of the scale and reported the Cronbach α value to be 0.73. In the present study, the Cronbach α value was 0.75.

Coping and Adaptation Process Scale. The Coping and Adaptation Process Scale developed by Callista Roy enables individuals to define their coping and adaptation strategies in critical and difficult situations.³¹ Catal and Dicle³² conducted a Turkish validity and reliability study of the scale and reported a Cronbach α value of 0.82 for the total scale and 0.65 to 0.77 for the subscales. In the present study, the Cronbach α value was 0.80.

Telephone Monitoring and Interview Form. The Telephone Monitoring and Interview Form was prepared by the authors of the present study based on social learning and adaptation theories. The form consisted of items on patient evaluation, defining the problems, patients’ current physical problems and how they were coping with emotional problems, training and reminders on relevant topics, determining common goals, and strengthening/encouraging self-efficacy. Before the phone call was ended, plans for solving the problems until the next call were noted on the form.

Diabetic foot model. A diabetic foot model, which closely approximates the human foot with dimensions of 22 cm × 8 cm (length × width) and weighing 300 g, was used in the training. The model is made of soft and elastic synthetic material, and the toes can be bent. This model is used to simulate invasive traumatic and diabetic ulcers at different developmental stages (Figure 2).

Training booklet. The training booklet was created based on the educational needs of individuals with diabetes who require training in foot self-care practices. The authors examined current research and evidence-based treatment guidelines and based the training information on the Roy Adaptation Model and Bandura’s Social Cognitive Theory.^6,12,13 Patient training includes definitions of diabetes, foot function, and anatomy, as well as information on healthy feet, development of diabetic foot, diabetes control, daily foot monitoring, daily foot care, nail cutting and care, shoe and socks selection, foot and leg exercises, prevention of foot injuries, regular check-ups, and what not to do.^6,12,13 The training booklet was prepared with the goal of improving patients’ perception of self-efficacy regarding diabetic foot care and increasing their adherence to their care regimen. After the training booklet was created, expert opinions were obtained from 7 academic nurses, 1 doctor, and 2 nurses who have extensive knowledge about diabetes and its theories, using the DISCERN Guide to evaluate the reliability and information quality of the training material.³³ Changes were made to the training booklet based on the suggestions of these experts.

Study design and procedure. This was a randomized controlled experimental study. The findings are reported according to the Consolidated Standards of Reporting Trials statement. The data were collected in the polyclinic education room between November 2019 and July 2020. All the interviews were performed by a single researcher (A.G.T). Patients with diabetes who met the sampling criteria were informed by the researcher about the purpose of the study, and their informed consent was obtained. Measurements were obtained at baseline and at 1, 3, and 6 months.

Intervention group. At baseline, the researcher provided all data collection forms to all participants in both groups. Patients in the intervention group received training on diabetic foot care practices using the diabetic foot model and received a foot care training booklet prepared by the researchers. Foot care behaviors, self-efficacy, and foot care practices were reevaluated at 1, 3, and 6 months. The training sessions were held in the training room of the İzmir Ataturk Training and Research Hospital Endocrine Polyclinic. Necessary permission was obtained to use the training room. Training was done during standard working hours on weekdays. Groups of 2 to 3 people at a time were trained in a 30- to 45-minute session, using the methods of expression, question and answer, and role play in line with the objectives of the training plan. The intervention group was telephoned every month (6 times in total) by the researcher to evaluate the effectiveness of the training, in line with the follow-up and interview steps. Telephone calls were placed between 11:00 am and 4:00 pm. Each telephone call lasted approximately 10 to 15 minutes, and the contents of these conversations were recorded on the Telephone Call Evaluation Form.

Control group. Control group participants received routine diabetes education in the outpatient clinic but did not have access to the diabetic foot model or the training booklet. Patients were reinterviewed 1, 3, and 6 months after the first interview, at which time individuals’ foot care behaviors, self-efficacy, and foot care practices were reevaluated. At the end of the study, the researcher provided training to the control group; this involved use of the diabetic foot model and provision of the training booklet.

Ethics review and approval. The necessary ethics committee permission was obtained from the Non-Invasive Clinical Research Ethics Committee (decision number 203). After receiving the permission of the ethics committee, institutional permission was obtained from the İzmir Ataturk Training and Research Hospital (number 47104536-799). After all patients who agreed to participate in the study were informed about the study, their written consent and permission to use the scales were obtained from the authors. The study conformed to the principles outlined in the Declaration of Helsinki.

Statistical analysis. Statistical analysis was done by the Istar Statistics Center. Power analysis was used to calculate sample size and power. SPSS for Windows v25 (IBM Corporation) was used to analyze the data collected in the study. Descriptive statistics were used. For data with a normal distribution, parametric tests were used. For quantitative data, an independent t test was used to compare 2 independent groups, and variance analysis was used for repeated measures to compare 2 dependent groups. The post hoc Bonferroni test was used to determine which 2 groups caused the difference when the variance analysis resulted in repeated measurements. For data with nonnormal distribution, nonparametric tests were used. For quantitative data, the Mann-Whitney U test was used to compare 2 independent groups, and the Friedman test was used to compare 2 dependent groups. When a difference was found based on the Friedman test, Bonferroni correction was used to determine which 2 groups caused the difference. Chi-square analysis was applied to test the relationship between the 2 categorical groups.

Sample characteristics. The mean age was 56.50 years ± 12.02 in the intervention group and 54.20 years ± 10.81 in the control group. Females comprised 62.5% of the intervention group and 65% of the the control group. In the intervention group, 37.5% of participants had diabetes duration of 10 years or more, compared with 45% in the control group. In both groups, 90% of patients had type 2 diabetes and 10% had type 1. Sixty-five percent of patients in the intervention group and 52.5% in the control group had never received diabetic foot care training (Table 2).

Metabolic control parameters. There was no statistically significant difference in HbA1c, fasting blood glucose, postprandial blood glucose, or body mass index values between the intervention group and the control group on a monthly basis (P > .05). However, in both groups the HbA_1C, fasting blood glucose, and postprandial blood glucose values were higher at the pretest time point than at 3 months and 6 months (Table 3).

Intervention effect on diabetic foot risk assessment, diabetic foot evaluation, self-efficacy, functional foot care, and coping and adaptation outcomes. In the posttest evaluation, 72.5% of patients in the control group and 40% in the intervention group were at high risk of diabetic foot. A statistically significant correlation was found between the diabetic foot risk assessment form posttest values of the intervention and control groups (chi-square: 8.584, P ˂ .003). Posttest results of toenail cutting behaviors in the intervention and control groups showed a statistically significant relationship between the groups (chi-square: 4.267, P < .05). Posttest results of the intervention and control groups showed a statistically significant relationship between shoe fit conditions (chi-square: 7.813, P < .05).

Diabetic Foot Care Self-Efficacy Scale. There was a statistically significant difference in mean Diabetic Foot Care Self-Efficacy Scale scores between the intervention and control groups at 1 month (73.12 ± 15.20 and 62.40 ± 15.14, respectively; t = −3.161, P = .002), 3 months (75.92 ± 14.39 and 61.52 ±15.81, respectively; t = −4.258, P < .001), and 6 months (80.67 ± 12.45 and 61.87 ± 15.39, respectively; t = −6.004, P < .001). These scores were higher in the intervention group than in the control group at 1 month, 3 months, and 6 months. There was a statistically significant difference between the within-group follow-up times in the intervention group (P < .001). In the intervention group, the 1-, 3-, and 6-month Diabetic Foot Care Self-Efficacy Scale scores were higher than the pretest score, and the mean score was higher at 6 months than at 1 month (Table 4).

Nottingham Assessment of Functional Footcare. There was a statistically significant difference in the mean Nottingham Assessment of Functional Footcare score between the intervention and control groups at 3 months (60.05 ± 7.91 and 49.67 ± 8.79, respectively; t = −5.545, P < .001) and 6 months (65.20 ± 6.09 and 49.60 ± 8.78, respectively; t = −9.224, P < .001). The mean score in the intervention group was higher than that of the control group at 1, 3, and 6 months. There was a statistically significant difference between the within-group follow-up times in the intervention group (P < .05). In the intervention group, the mean Nottingham Assessment of Functional Footcare score was higher at 3 months and 6 months than at the pretest and at 1 month. In addition, the mean score was higher at 6 months than at 3 months in the intervention group (Table 4).

Coping and Adaptation Process Scale. There was a statistically significant difference in the 6-month mean Coping and Adaptation Process Scale score between the intervention and control groups (148.30 ± 15.52 and 129.15 ± 15.57, respectively; P < .001). In the intervention group, there was a statistically significant difference in the within-group follow-up times (P < .001). In the intervention group, the 6-month mean Coping and Adaptation Process Scale score was higher than the pretest, 1-month, and 3-month scores (Table 4).

To the best of the authors’ knowledge, this study is the first in Turkey to implement a training program on foot care in individuals with diabetes in which a diabetic foot model, the Roy Adaptation Model, and Bandura’s Social Cognitive Learning Theory are used together.

The fact that there was no significant difference between the groups in terms of characteristics such as age, sex, duration of diabetes, diabetes-related complications, and receiving diabetes education indicates that the study groups had similar characteristics and that the results obtained were not affected by sociodemographic characteristics.

Published studies indicate that neuropathy and retinopathy are the leading complications of diabetes in Turkey.^22,24 The present study reports similar findings.  All patients with diabetes and their families, especially patients with high-risk foot issues (history of ulcer or amputation, deformity, loss of protective sensation, or peripheral arterial disease), should receive basic education on risk factors and care. Patients at risk should know the consequences of foot deformities, loss of protective sensation, and peripheral arterial disease, as well as proper foot care, including nail and skin care, and the importance of daily foot monitoring. Patients with loss of protective sensation should be taught how to monitor early foot problems using different sensory modalities (palpation or visual inspection using an unbreakable mirror).¹³ Foot complications and amputations are reduced by up to 85% with comprehensive diabetic foot problems, risk assessments, and foot care based on prevention, education, and support by a multidisciplinary team.²

Huda et al²¹ found that individuals with type 2 diabetes who had low self-efficacy were not sure how to properly cut their toenails and that their toenail clipping behaviors were wrong. Kilic and Karadağ²⁴ reported a significant difference in shoe selection before and after training to use a mobile application to aid in shoe selection. After receiving the training, 10 patients corrected their mistakes in shoe selection.

Glycemic control is essential for diabetes management. Prospective randomized controlled trials show that good glycemic control reduces the rate of development and progression of microvascular complications (retinopathy, neuropathy, and diabetic kidney disease).^34-36 A randomized controlled study showed that by the end of a 12-week nurse-led diabetes education program, the HbA_1c, body mass index, and blood pressure values of patients in the treatment group had decreased significantly compared with those of the control group.³⁵

High self-efficacy in individuals with diabetes can reduce and prevent complications, such as neuropathy and diabetic foot, and can provide metabolic control values within safe ranges.³⁶ The concept of self-efficacy suggests that patients’ self-confidence influences their ability to display healthy behaviors and the behaviors they are involved in. Because self-care in diabetes includes behavioral, personal, and environmental factors, the concept of self-efficacy is appropriate for promoting self-care in patients with diabetes. Self-efficacy is an important factor in performing skills and behaviors while trying to eliminate obstacles and problems in self-care behaviors.³⁷ Ahmad Sharoni et al³⁸ conducted a 12-week randomized controlled trial of older adults with diabetes and found that foot care self-efficacy in the treatment group increased after training.

In a study evaluating foot care behaviors, the factors determined to affect the Nottingham Assessment of Functional Footcare score were place of residence, literacy level, monthly income, family history of diabetes, and foot care education supplied by health care providers.³⁹ In a study like the present one, an audiovisual podiatry patient education module used in an outpatient setting was found to be an effective tool in improving foot care knowledge and practice in patients with diabetes.¹⁰ Patient education is an important element of diabetes care in developing knowledge, skills, and self-care behaviors. There is evidence that educational programs offered in a structured and iterative way improve foot care knowledge and behavior.^13,40

The overall management of type 2 diabetes is influenced by patients’ individual coping responses. It has been reported that coping skills are effective in adaptation to self-care in people with diabetes.⁴¹ In a study of women with diabetes in which the Roy Adaptation Model was used, statistically significant results were obtained between psychosocial adjustment in diabetes and diabetes self-management behaviors.⁴⁰ Adaptive behaviors are the only way to manage diabetes, increase self-management behaviors, and prevent complications.⁴²

In two studies, theoretical foot care training and regular supportive telephone calls improved foot self-care behavior and prevented minor problems of the foot.^43,44 Tele-nursing is a very useful method of assessing patients’ care needs and reducing the frequency of check-ups.^24,45 Using the telephone not only reduces costs and facilitates access to effective health care, but it also improves relationships between patients and health care providers. It can also remove barriers related to time and distance.⁴⁶

Diabetes educators regularly use theoretical knowledge, even if they do not realize it. To teach, it is necessary to have some assumptions about how people learn and what constitutes effective teaching. Theories are important tools that provide an effective, strong, and consistent basis for the design, understanding, and conduct of research on the education of patients with diabetes. Diabetes educators benefit from theory-based interventions.^9,44,47

This study has limitations. The inclusion of 1 hospital in the study is a limitation because of the difficulties experienced by the researcher in obtaining time and permission to conduct this work.

To the authors’ knowledge, this is the first study in which the Roy Adaptation Model and Social Cognitive Learning Theory were used together in diabetic foot care training. Diabetic foot care training and telephone follow-up developed and carried out in line with Social Cognitive Learning Theory and the Roy Adaptation Model were effective in improving foot care behaviors, facilitating the coping and adaptation process of individuals with diabetes, and increasing these individuals’ self-efficacy regarding foot care.

Acknowledgments: The authors express their gratitude to all the study participants for their time and effort.

Affiliations: ¹İzmir Ataturk Training and Research Hospital, İzmir, Turkey; ²Ege University, İzmir, Turkey

ORCID: Akyol, 0000-0003-1018-4715; Tolasa, 0000-0003-0649-7858

Disclosure: The authors report no financial or other conflicts of interest. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Correspondence: Arzu Güngör Tolasa, PhD; İzmir Ataturk Training and Research Hospital: İzmir Ataturk Egitim ve Arastirma Hastanesi, Internal Medicine Clinic, Hasan Tahsin Street No: 143 35150 Karabağlar/İzmir, İzmir, İzmir 35120 Turkey; arzugungor18@hotmail.com

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