The effect of a mobile application on the foot care of individuals with type 2 diabetes: A randomised controlled study

Abstract

Objective:

This study aimed to develop an animation-supported Mobile Diabetic Foot Care Education (M-DFCE) application for use by individuals with type 2 diabetes and identify its effects on knowledge, self-efficacy and foot care behaviour.

Design:

Randomised, controlled experimental study.

Setting and Method:

The study was carried out between October 2016 and September 2017. The sample consisted of 130 individuals with diabetes (65 in the experimental group and 65 in the control group). The experimental group received M-DFCE. Data were collected using the Patient Assessment Form, the Diabetes Foot Knowledge Questionnaire, the Diabetic Foot Care Self-Efficacy Scale and the Foot Self-Care Behaviour Scale. Differences between the groups were examined using Student’s t, Mann–Whitney U, Wilcoxon Signed Rank and Paired Sample tests.

Results:

Although there was no difference between the groups at initial evaluation, individuals in the experimental group who received animation-supported M-DFCE had significantly higher knowledge, self-efficacy and foot care behaviour levels than the control group.

Conclusion:

The animation-supported mobile application developed for foot care education was effective in increasing the individuals’ knowledge, self-efficacy and behaviour with respect to foot care.

Keywords

diabetic foot mobile application patient education type 2 diabetes

Introduction

Diabetes is one of the biggest health problems of our century (Saeedi et al., 2019). As a result of changes in lifestyle, the prevalence of type 2 diabetes is rapidly increasing internationally. According to the International Diabetes Federation (IDF, 2019), the number of people with diabetes (aged between 20 and 79) was approximately 463 million worldwide (Saeedi et al., 2019). If left uncontrolled, diabetes affects all the systems in the body and causes numerous complications (American Diabetes Association [ADA], 2017; Saeedi et al., 2019). One of the most severe and common complications of diabetes is diabetic foot (ADA, 2017). Lower limb amputations are preceded by foot ulcers in around 75%–85% of cases (Arshad et al., 2020).

Diabetic foot wounds and amputations can be reduced by 85% thanks to good foot care training and a multidisciplinary approach (IDF, 2017). Good knowledge, attitudes and behaviour with respect to foot care are important factors in preventing foot wounds in diabetes (Monteiro-Soares et al., 2020). The International Working Group on the Diabetic Foot (IWGDF) guidance recommends that preventive foot care should be beneficial, cost-effective and efficient and should be offered to particularly high-risk patient groups (Schaper et al., 2016). The guidance recommends further research into methods and technology to change knowledge and behaviour regarding foot care (Schaper et al., 2016).

The use of mobile applications (apps) in health is increasing worldwide. According to the 2019 Global Digital report, there are 5.11 billion mobile users across the globe; two out of three of them own mobile phones and users spend up half of their time on the Internet using mobile applications (Kemp, 2019). Mobile health technologies are used in diabetes as well as in the management of other chronic diseases. The published literature includes studies regarding the effects of the Internet and mobile phones on self-care activities in diabetes (Kim et al., 2015; Bian et al., 2017), glycaemic control management (Abbas et al., 2015), improving knowledge, behaviour and self-efficacy (Guo et al., 2015) and the prevention of diabetes (Fukuoka et al., 2015). Thanks to the features of mobile devices such as portability, instant access to information and video recording patients can access and receive information about their diseases in the desired environment (Kim et al., 2015).

The use of colourful and visually stimulating material can make mobile apps especially desirable (Katifori et al., 2020). Animations can enrich teaching environments through the use of imagery and sound together (Latif et al., 2016). Through the use of animation, the difficulties of concretising and visualising abstract concepts can be reduced. In recent years, mobile apps have become a part of patient education and their use has increased (Abrar et al., 2020; Latif et al., 2016). Technology-integrated and animation-based education is gradually gaining importance as part of diabetic foot care education.

There are many studies on the success of animation-based patient education (Abrar et al., 2020; Ahmed et al., 2015; Kayler et al., 2020). Animations can increase the effectiveness of teaching through their colourful and visual content and can make education more meaningful (Latif et al., 2016). In contrast to videos of real people, animations have the potential to explain complex concepts simply (Kayler et al., 2020). While real photographs may be suitable for representing static objects, colourful and visually rich animations are more effective in complex forms of patient education (Choi, 2011; Tumminello, 2005). In addition, education with animation may be advantageous for elderly patients with low health literacy (Ahmed et al., 2015) and individuals with low motivation and cognitive learning skills (Slater and Rouner, 2002).

Animation-supported mobile education apps for diabetic foot care and related preventive measures are important because they allow easy access to information for patients and help them manage foot care more easily (Abrar et al., 2020; Latif et al., 2016). Although studies have used mobile technology as part of diabetic foot care education (Brown et al., 2017; Fraiwan et al., 2017), no mobile app with animation content has been reported. In this study we aimed to develop a mobile app which was safe, practical and easily used in clinical settings. The app aimed to increase knowledge, self-efficacy and preventive behaviour in the short term and prevent the formation of foot wounds in the longer term, thereby reducing the incidence of diabetic foot amputation and acting as a guide for diabetes nurses regarding diabetic foot education.

Study objectives

This study was conducted to develop an animation-supported Mobile Diabetic Foot Care Education (M-DFCE) app to be given to individuals with type 2 diabetes and to determine the effect of the education provided on the knowledge, self-efficacy and behaviour of individuals with diabetes with respect to foot care.

Study hypotheses

Three study hypotheses were developed:

H1. An animation-supported M-DFCE app would be effective in increasing knowledge about diabetic foot care among individuals with diabetes.

H2. An animation-supported M-DFCE app would be effective in increasing self-efficacy with respect to foot care among individuals with diabetes.

H3. An animation-supported M-DFCE app would be effective in increasing relevant behaviour with respect to diabetic foot care among individuals with diabetes.

Materials and methods

Study design and sample

The study took the form of a randomised, controlled experimental study conducted at the diabetes outpatient clinic of a university hospital in Istanbul between October 2016 and September 2017. The study population comprised individuals with diabetes presenting to the diabetes clinic of the hospital. A power analysis based on previous research (Biçer and Enç, 2016; Sahin and Naylor, 2017) was used to estimate the sample size. Assuming a power of 80% and an α of .05, a sample size of 130 was deemed appropriate. The experimental and control groups therefore consisted of 65 individuals. A computer-based random number generator was used to divide eligible patients into groups.

Turkish-speaking individuals who were 18 years of age or older and were literate and diagnosed with diabetes at least 6 months previously according to the ADA criteria were included in the study. Participants did not have a diabetic foot wound, were able to use a smartphone, did not have communication and mental health problems and had volunteered to participate in the study. Patients with foot wounds and severe retinopathy were excluded from the study. The study design complied with guidelines on the Consolidated Standards of Reporting Trials (CONSORT) Checklist (Figure 1) and was registered in registered at ClinicalTrials.gov (Reference: NCT04265469).

Figure 1.

Allocation of subjects according to the CONSORT 2010 flow diagram.

Data collection

Data were collected using a Patient Assessment Form, the Diabetes Foot Knowledge Questionnaire (DFKQ), the Diabetic Foot Care Self-Efficacy Scale (DFCSES) and the Foot Self-Care Behaviour Scale (FSCBS). These scales were chosen since they were fit for Turkish culture and the purpose of the study. While data from individuals in the control group were collected using paper-pencil form, the data in the experimental group were sent to the researcher by e-mail.

Patient assessment form

Prepared by the researchers in accordance with the literature (Biçer and Enç, 2016; Sahin and Naylor, 2017), this form included 11 questions on age, gender, marital status, educational status, household membership, duration of diabetes, Haemoglobin A1c (HbA1c), type of diabetes therapy, smoking/alcohol consumption and compliance with treatment.

DFKQ

The five-item scale, which is a part of the Diabetes Knowledge Questionnaire-24 and assesses patients’ level of knowledge on foot care, was developed by Garcia et al. (2001). The validity and reliability of the Turkish version were assessed by Biçer and Enç (2016) and had a .58 Cronbach’s alpha value. This study found the Cronbach’s alpha value to be .72. Possible answers to the items include ‘yes’, ‘no’ and ‘I do not know’. The questionnaire is evaluated based on the total score. The correct answer was scored one point, while other answers scored zero point. The highest obtainable scale score is five. An increase in the score indicates that the individual with diabetes has an increased level of knowledge of foot care.

DFCSES

The scale which was developed by Quarles (2005) and adapted into Turkish by Biçer and Enç (2016) assessed individuals with diabetes perceived capability to performing diabetic foot care. A 10-point Likert-type instrument consisting of nine items is evaluated on a visual scale ranging from 0 to 10, with 0 indicating ‘feeling not capable of’ and 10 being ‘feeling the most capable of’. The lowest obtainable scale score is 0 and the highest is 90. An increase in score indicates that the individual’s level of self-efficacy has increased. The Cronbach’s alpha value of the scale was .94 in the study by Biçer and Enç (2016) and was .87 in this study.

FSCBS

This scale, developed by Borges and Ostwald (2008) and adapted into Turkish by Biçer and Enç (2016), assesses self-care behaviours in foot care. The 15-item 5-point Likert-type scale is scored as 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often and 5 = Always. The lowest obtainable scale is 15, while the highest is 75. An increase in the score indicates improved self-care behaviour. The Cronbach’s alpha value for the scale was .83 in the study by Biçer and Enç (2016) and was .81 in this study.

Development of the animation-supported M-DFCE

The M-DFCE app consists of cartoon animation video and contains the basic information required for successful foot care. The development process of the app took place over approximately 5 months (1 October 2016–28 February 2017). The researchers developed educational content covering all guidelines for foot care in diabetes (ADA, 2017; IDF, 2017) consensus report (Saltoğlu et al., 2015) and the content of the data collection tools used. The script of the video was divided into sex sections: (1) Diabetes and Foot Problems, (2) Daily Foot Care, (3) What Kind of Socks? (4) What Kind of Shoes? (5) Nail Care and (6) Things to be Considered in Daily Life.

The video provides basic information about daily foot care to prevent foot wounds in diabetic individuals and the six sections comprise a single video with animation. To assist in the preparation of the mobile software and video (Figure 2), the ADDIE (Analysis, Design, Development, Implementation, Evaluation) Design Model was used. The storyboards and scenarios within the animations were created by the researchers (B.D., N.B.) with the support of software specialists and mobile/computer programmers through service purchases. The animation video was dubbed into Turkish by a professional actor. The development of the M-DFCE programme was supported by 15 experts in diabetic foot and mobile technologies (certified diabetes nurses, certified wound care nurses, university experts in diabetes, university experts in mobile design, teaching technology experts, software specialists, etc.) after it had been finalised. Experts reviewed the software for scientific content (e.g. whether the content taught was correct), instructional suitability (e.g. whether the scope of the taught content is sufficient), educational programme compliance, technical quality (e.g. whether the graphics, text, sound and animations were in line with the content in the software) and visual quality (e.g. screen design conforms to visual principles) and found the software adequate.

Figure 2.

Animation-based M-DFCE.

A pilot study was conducted to evaluate the use of the M-DFCE programme with patients. A total of 15 individuals with diabetes who met the sample group criteria were selected. Patients were asked open-ended questions about M-DFCE (how they found the mobile application training programme, the parts of the video they found incomplete or unnecessary and the ease of use and comprehensibility of the mobile application). Individuals included in the pilot testing were not included in the main study.

The application was finalised in line with the feedback received from the experts and pilot-tested individuals. It comprised six sections as above with each section lasting for approximately 1 minute 30 seconds.

Intervention

Control group

The control group received education in diabetic foot care in line with clinical guidelines in the hospital diabetes education room. Routinely used in the hospital, the education included the provision of printed visual education material detailing daily things to do. Patients received the education individually via direct instruction, question–answer and discussion methods. They were asked to complete the DFKQ, DFCSES and FSCBS scales using pencil-paper before and 1 month after the education was given.

Experimental group

Individuals in the experimental group were first informed about the use of the mobile app. The app was downloaded on the patient’s phone by the researcher and a username and password created to protect privacy and confidentiality. The use of the mobile app was taught to patients by having them try out the app several times under the supervision of the researcher. Patients were also taught how to redownload the application if it became deleted and their username and password were written down on a piece of paper and given to them. Afterwards, the experimental group was asked to use the app to receive foot care education at home. Individuals received push notifications to do so twice a week. Push notifications containing visual cartoon images were sent twice a week to members of the experimental group to encourage continued use. They were asked to complete the DFKQ, DFCSES and FSCBS scales before and 1 month after the education. They were called 2 days in advance to remind them to do so and scales were uploaded into the mobile app. Data were sent electronically from the mobile app to the researcher (B.D.) via e-mail. The number and duration of the video views were also sent this way to the researcher.

Outcomes

The primary outcome of this study was an increase in Diabetes Foot Care Knowledge Questionnaire levels of individuals after the use of the app. Secondary outcomes were an increase in scores on the DFCSES and the FSCBS following app-supported education.

Data analysis

Data were analysed using SPSS (Statistical Package for Social Sciences, Chicago, IL, USA) version 16.0. The Shapiro–Wilks test was used to assess whether the data had a normal distribution. Averages, percentages, frequencies, mean and median values were calculated as part of descriptive analysis. The Pearson chi-square test and the Fisher–Freeman–Halton test were used to compare gender, marital status, educational status, persons living with, diabetes treatment type, smoking and alcohol consumption in the experimental and control groups. Treatment type and treatment compliance in diabetes were compared using the Fisher–Freeman–Halton test. Student’s t and Mann–Whitney U tests were used to compare age, Haemoglobin A1c and duration of diabetes in both groups. Student’s t test was used for normally distributed data and the Mann–Whitney U test for non-normally distributed data in comparing first and final assessments of the experimental and control groups with respect to the DFKQ, DFCSES and FSCBS scales. The Wilcoxon signed rank test was used for paired comparisons within groups. The reliability of the scales used in the study was assessed using Cronbach’s alpha reliability coefficient. All results with a p value of <.05 and a confidence interval of 95% were considered significant.

Ethical considerations

Approval to conduct the research was obtained from the Marmara University Health Science Institute Ethics Committee (30052016-44) and the İstanbul Northern Anatolian Association of Public Hospitals (77517973-770). Written informed consent was received from patients in the experimental and control groups included in the study. Permission was obtained via e-mail for the scales used in the study. Members of the control group were provided with the app after the completion of the study.

Results

Of the individuals in the experimental group, 47.7% were women, 81.5% were married, 47.7% were primary school graduates and 84.6% were living with their family. Their mean age was 49.5 ± 17.4. Of the individuals in the control group, 50.8% were women, 80% were married, 32.3% were primary school graduates and 87.7% were living with their family. Their mean age was 54.7 ± 13.6. There was no significant difference between the experimental and control groups in terms of duration of diabetes, HbA1c, diabetes treatment type, smoking/alcohol consumption and compliance with treatment (p > .05) (Table 1).

Study Hypothesis 1: An animation-supported M-DFCE app would be effective in increasing knowledge about diabetic foot care among individuals with diabetes.

The knowledge level of patients in the experimental group concerning diabetic foot care was 3.6 (1.6–5) before the animation-supported M-DFCE and 4.6 (1.6–5) 1 month after receipt of education. There was a significant increase in the knowledge level of the patients in the experimental group about foot care (p = .001). The initial assessment score of the control group was 3.6 (1.6–5), while the final assessment knowledge score was 3.6 (2.33–5). There was no significant increase in the knowledge score of the control group between first and final assessment (p = .905) (Table 2).

Study Hypothesis 2: An animation-supported M-DFCE app would be effective in increasing self-efficacy with respect to foot care among individuals with diabetes.

The diabetic foot care self-efficacy levels of the individuals in the experimental group with type 2 diabetes increased significantly after the animation-supported M-DFCE (first assessment 59 [6–90], final assessment 76 [31–90]) and there was no significant increase (p = .774) in the self-efficacy levels of the control group (first assessment 64 [15–90], final assessment 65 [23–90]) (Table 2).

Study Hypothesis 3: An animation-supported M-DFCE app would be effective in increasing relevant behaviour with respect to diabetic foot care among individuals with diabetes.

The diabetic foot care behaviour score was 52 (16–72) before the app-supported education compared to 63 (30–75) 1 month after education. Pre-training diabetic foot care behaviour score was 52 (15–70) in the control group and 43 (25–75) 1 month after the education. While there was a significant increase in diabetic foot care behaviour level in the experimental group (p = .001), no significant increase was found in the control group (p = .927) (Table 2).

Table 1.

Participants in the experimental and control groups.

Variable		Group		Value
Variable		Control (n = 65)	Experimental (n = 65)	p
Age	M ± SD	54.7 ± 13.6	49.5 ± 17.4	t:1.902^a.060
		n (%)	n (%)
Gender	Female	33 (50.8)	31 (47.7)	χ²:0.123^b.726
Gender	Male	32 (49.2)	34 (52.3)	χ²:0.123^b.726
Marital status	Married	52 (80.0)	53 (81.5)	χ²:0.050^b.824
Marital status	Single	13 (20.0)	12 (18.5)	χ²:0.050^b.824
Educational status	Primary school	21 (32.3)	31 (47.7)	χ²:4.411^b.353
	Secondary school	13 (20.0)	9 (13.8)
	High school	14 (21.5)	8 (12.3)
	University	17 (26.3)	17 (26.2)
Persons living together with	Family	57 (87.7)	55 (84.6)	χ²:0.258^b.612
Persons living together with	Alone-friend	8 (12.3)	10 (15.4)	χ²:0.258^b.612
Diabetes treatment type	Diet	0 (0.0)	5 (7.7)	χ²:7.197^c.062
	Oral Anti-Diabetic (OAD)	9 (13.8)	5 (7.7)
	Insulin	32 (49.2)	37 (56.9)
	OAD + Insulin	24 (36.9)	18 (27.7)
Smoking	Yes	14 (21.5)	14 (21.5)	χ²:0.000^b1.000
Smoking	No	51 (78.5)	51 (78.5)	χ²:0.000^b1.000
Alcohol consumption	Yes	7 (10.8)	4 (6.2)	χ²:0.894^b.344
Alcohol consumption	No	58 (89.2)	61 (93.8)	χ²:0.894^b.344
Compliance with treatment	Well	24 (36.9)	27 (41.5)	χ²:3.750^c.143
	Moderate	2 (3.1)	7 (10.8)
	Worse	39 (60.0)	31 (47.7)
Duration of diabetes (month)	Min–Max (Median)	1–540 (132)	1–504 (120)	Z:−0.569^d.569
HbA1c	M ± SD	7.9 ± 1.3	7.9 ± 1.5	t = 0.030^a.976

Data are provided as M ± SD (min–max).

Student’s t test.

Pearson chi-square test.

Fisher–Freeman–Halton test.

Mann–Whitney U test.

Table 2.

Comparison of the first assessment and final interview of the experimental and control groups regarding Diabetes Foot Knowledge Questionnaire (DFKQ). Diabetic Foot Care Self Efficacy Scale (DFCSES) and Foot Self Care Behavior Scale (FSCBS).

Scales		Diabetes Foot Knowledge Questionnaire (DFKQ)			Diabetic Foot Care Self Efficacy Scale (DFCSES)			Foot Self Care Behaviour Scale (FSCBS)
		Control (N = 65)	Experimental (N = 65)	Test valueP	Control (N = 65)	Experimental (N = 65)	Test valueP	Control (N = 65)	Experimental (N = 65)	Test valueP
First assessment	Medyan (Min–Max)	3.6 (1.6–5)	3.6 (1.6–5)	t:1.014^a.312	64 (15–90)	59 (6–90)	t:0.205^a0.838	52 (15–70)	52 (16–72)	t:−0.090^a.928
Final assessment	Medyan (Min–Max)	3.6 (2.3–5)	4.6 (1.6–5)	Z:−7.008^c.001**	65 (23–90)	76 (31–90)	Z:−3.159^c.002**	43 (25–75)	63 (30–75)	Z:−2.004^c.045*
First-Final assessment	Difference	0.01 ± 1.25	0.87 ± 1.21	Z:−4.139^c.001**	0.63 ± 3.31	13.4 ± 25.4	Z:−3.050^c.002**	0.6 ± 24.85	11.28 ± 10.47	Z:−2.525^c.012*
	Test value	Z:−0.120	Z:−4.992		Z:−0.288	Z:−4.256		Z:−0.092	Z:−6.383
	p	^f.905	^f.001**		^f.774	^f.001**		^f.927	^f.001**

Data are provided as median ± SD (min–max).

Student-t Test.

Mann Whitney U test.

Wilcoxon Signed Ranks Test

p < .05; **p < .01.

Discussion

Education videos are widely regarded as effective ways of increasing health-related knowledge. Given the benefits of educational animation and high levels of patient satisfaction, this method has been used in various fields of healthcare (Brame, 2016; de Koning et al., 2017). Studies have revealed that animation-based diabetes education can be effective in increasing patients’ level of knowledge (Al Owaifeer et al., 2018; Dahodwala et al., 2018). This study found that a mobile app supported by an animation video caused an increase in the patients’ level of knowledge.

Patients with a high perception of self-efficacy manage diabetes better (Biçer and Enç, 2016). In this study, the increase in self-efficacy scores of patients using the app was greater than that of the individuals given routine education in the hospital. Training given by means of animation videos has been shown to increase the knowledge and attitudes of patients and facilitates adaptation to the disease (Al Owaifeer et al., 2018). In addition, animation videos increase the attractiveness of the education and enable the information to inform subsequent behaviour (Kayler et al., 2020). Other studies (e.g. Bahador et al., 2017; McMillian et al., 2016) have shown that foot care education can increase the self-efficacy of patients, which parallels findings from this study.

The foot care behaviour scores of individuals receiving the animation-supported M-DFCE increased significantly compared to those of the control group. There are many studies revealing that mobile applications create positive behavioural changes in individuals with diabetes (Fu et al., 2017; Hoppe et al., 2017; Sigdel and Doyle, 2017; Summers and Curtis, 2020; Ye et al., 2018). Compared to other studies, the follow-up period of the patients in this study was limited to 1 month reflecting short-term change. Research to assess longer-term patient outcomes could identify whether changes in knowledge, attitudes and behaviour are maintained in the long run.

Limitations

The fact that this study was conducted at a single specialist centre (the diabetes outpatient clinic of a university hospital) limits generalisability. The inclusion of literate patients and those who were able to use smartphones was another limitation. The study reflected the knowledge, attitude and behaviour change over 1 month. Further studies in which animated mobile applications are evaluated over a longer period of time are warranted. As a result, the intervention needs to be tested more extensively before implementation in clinical practice.

Conclusion

Animation-supported M-DFCE proved effective in increasing foot care knowledge, self-efficacy and behaviour among individuals with type 2 diabetes. Although there are several studies of the use of mobile technology for diabetic foot care education in the literature (Abrar et al., 2020; Latif et al., 2016), none of them detail the use of a mobile app with animation content. Findings from this study have the potential to be used in clinical practice after further testing and development.

Footnotes

Acknowledgements

We thank patients for their participation in the study.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Berna Dincer

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