Abstract
Lower extremity amputation as a treatment of diabetic foot ulcer is probably a major burden for the patient's family and friends, who typically act as caregivers and support the patient in coping with the physical disabilities and emotional distress. In the present prospective study, we investigated the effects of different lower extremity amputation levels for diabetic foot ulcer treatment on caregivers of patients with diabetes using the Zarit Burden Interview (ZBI‐12) scale. Patients with diabetic foot ulcers who underwent unilateral major amputation (above‐below knee) and minor amputation of foot (heel sparing) and their caregivers were requested to volunteer to participate in this study from June 2016 to December 2018. The ZBI‐12 form was completed immediately preoperatively and 3 and 6 months after postoperatively. In the minor amputation group, the mean age of the 51 patients was 72.1 years. In the major amputation group, the mean age of the 88 patients was 73.7 years. Both groups of caregivers of patients with minor amputation and major amputations showed a significant improvement in ZBI‐12 score when compared preoperatively and at 3‐ and 6‐month follow‐up visits. The mean ZBI‐12 score was significantly higher in the major than in the minor amputation group in preoperative and all postoperative visits. The absence of the ankle joint in the below‐ or above‐knee amputation renders it more difficult for the amputee to quickly learn the use of prosthesis, thereby increasing the burden of the patient and caregivers. We found that lower extremity amputation for the treatment of chronic diabetic foot ulcers has significantly favourable effect on the caregiver burden, and thereby heel sparing was considerably more effective for the caregiver burden.
Keywords: caregiver burden, diabetic foot ulcer, heel sparing, lower extremity amputation, Zarit Burden Interview
1. INTRODUCTION
The prevalence of diabetes mellitus (DM) is increasing, and the disease currently represents a serious public health issue.1 Diabetic foot ulcers are one of the major complications of DM and have a substantial impact on the health status of the affected patients.2 Although there have been advancements with regard to understanding the pathogenesis, treatment and prevention of the disease, diabetic foot ulcers heal gradually, typically requiring intensive treatment for a long duration.3, 4 Therefore, although amputation is an important treatment option for diabetic foot, it poses additional issues for patients and caregivers.
Lower extremity amputation causes physical, psychological, and emotional dysfunction, necessitating caregiver's support for rehabilitation and general health care.5, 6, 7 Several previous studies have associated amputation care with psychological and financial burden and physical and mental stress on the family; moreover, amputation care has an impact on social relationships. Focusing on the heavy burden borne by caregivers and emphasising on their often unmet needs may help raise awareness of the impact of amputation on the patient's family within the health care community. Moreover, such information may provide a useful resource for defining structured intervention aimed at assessing, preventing, or managing issues related to stressful caregiving situations across the care continuum.8
Lower extremity amputation as a treatment of diabetic foot ulcer is probably a major burden for the patient's family and friends, who typically act as caregivers and support the patients in coping with the physical disabilities and emotional distress. In the present study, we aimed to determine the impact of amputation and its levels in patients with diabetic foot ulcer in caregivers.
2. MATERIALS AND METHODS
2.1. Study design
This prospective descriptive study was conducted at a single‐level trauma centre in Turkey from June 2016 to December 2018. Patients with unilateral major amputation (above‐below knee) and minor amputation of the foot (heel sparing) were requested to volunteer to participate in the present study. The study was approved by the Institutional Review Board of the National Institute of Orthopaedic and Traumatology. All primary caregivers provided their written informed consent on behalf of the patients.
A prospective cohort study was conducted using a questionnaire to assess the primary caregiver's sense of burden at the initiation of the study and during the study period and its relationship to the lower extremity amputation level during this period.
2.2. Study population
Inclusion criteria for patient‐caregiver pairs were as follows: caregiver must be a family member of the patient, patient must be diagnosed with DM type 2 and have a unilateral chronic diabetic foot ulcer (ulcer duration ≥6 weeks), patients must have been followed up for at least 6 months post‐discharge, and patients should be aged >60 years and should have provided signed informed consent after agreeing to participate in the study. Main exclusion criteria were as follows: diagnosis of peripheral arterial disease, type 1 diabetes, previous amputation history of contralateral lower extremity, rehospitalisation after the amputation surgery because of recurrence wound, non‐use of prosthesis after amputation, inability of the primary caregivers to complete the questionnaires due to mental illness or other diseases, caregivers receiving monetary compensation for providing care, inability of patients to turn over or those who are completely bedridden, and patients lost to follow‐up. A total of 139 participants were included in the study.
2.3. Data collection
The observational period was approximately 6 months from June 2016 to December 2018. The Zarit Burden Interview (ZBI) form was completed immediately preoperatively and 3 and 6 months after postoperatively. The patients were divided into two groups: those who underwent a minor amputation (group 1) and those who underwent a major amputation (group 2). The major amputation group was further divided into two groups: above‐knee (group A) and below‐knee (group B) amputations.
The caregiver's age, sex, educational level, monthly income, relationship to the patient, duration of care (years), hours spent together per day, and existence of any diagnosed physical or psychological disease as well as the age, sex, and educational level of the person receiving the care were recorded using a sociodemographic data form.
The ZBI form was developed by Zarit et al to subjectively evaluate the level of the burden of care in chronic disorders.9 Bedard et al suggested a consolidated and short 12‐item ZBI,10 a version of the original 22‐item ZBI where higher scores represent higher burden. ZBI is a widely used tool to describe caregiver burden and has been well validated in various caregivers. The scores from the 12‐item version have previously been assessed to show good correlation with the original version in caregivers of patients with advanced chronic diseases. A score of ≥17 has been recommended as an indicator for high caregiver burden.11 The 12 items of this version of ZBI were categorised into two domains: personal strain and role strain. Each question is scored in a five‐point Likert scale from 0 to 4 (never to almost always). A high score represents higher burden. The range of summed score is 0 to 48. The groups were compared before and after the operation within themselves and a between‐group comparison was also performed.
2.4. Statistical analyses
For the evaluation of descriptive statistics, percentages derived from the scores of the scales were stated arithmetically as mean ± SD (minimum‐maximum). Because some of the data were not normally distributed, nonparametric tests were used. In the primary analyses, we compared the ZBI at each time point between the two groups (minor and major amputation: Student's t test). Changes during the follow‐up period within each group were analysed using the Wilcoxon rank‐sum test. Statistical analyses were performed using the statistical package for the social sciences (SPSS, Chicago, Illinois). A P value of ≤.05 was considered to indicate statistical significance. The procedures were explained in detail and written informed consent was obtained from all patients.
3. RESULTS
A total of 139 patients (51 [37%] and 88 [63%] patients with minor and major amputations, respectively) and their respective caregivers met the inclusive criteria and completed the investigation.
3.1. Caregiver characteristics
Among the 139 caregivers (mean age, 56.8 ± 9.1 years), 78% were females and 74% were married. The relationship between caregiver and patient was as follows: 40% were adult children, 47% spouse, 5.2% parents, and 7.8% siblings. The caregivers spent 39.1 months in caring for the patients (Table 1).
Table 1.
Demographic data of patients and caregivers
| Patients with minor amputations, n (%) | Patients with major amputations, n (%) | Total patients, n (%) | |
|---|---|---|---|
| Patients | 51 (37%) | 88 (63%) | 139 |
| Sex | |||
| Male | 32 (62%) | 62 (70%) | 94 (67%) |
| Female | 19 (38%) | 16 (30%) | 45 (33%) |
| Age (years) | 71.2 | 73.7 | 72.8 |
| Hospital stay (days) | 23.1 | 13.2 | 17.7 |
| Caregivers | |||
| Sex | |||
| Male | 13 (26%) | 17 (20%) | 30 (22%) |
| Female | 38 (74%) | 71 (80%) | 109 (78%) |
| Age (years) | 57.2 | 56.4 | 56.8 |
| Education level | |||
| Illiterate | 16 (31%) | 25 (28%) | 41 (29%) |
| Primary school | 24 (47%) | 34 (38%) | 58 (41%) |
| High school | 11 (22%) | 29 (34%) | 40 (30%) |
| Monthly income ($) | |||
| 0–250 | 28 (54%) | 42 (47%) | 70 (50%) |
| 250–500 | 15 (29%) | 28 (31%) | 43 (30%) |
| >500 | 8 (17%) | 18 (22%) | 26 (20%) |
| Duration of care (months) | 35.1 | 42.3 | 39.1 |
| Relationship | |||
| Wife | 16 (31%) | 36 (41%) | 52 (37%) |
| Husband | 7 (13%) | 7 (8%) | 14 (10%) |
| Son | 9 (17%) | 15 (17%) | 24 (17%) |
| Daughter | 14 (27%) | 18 (20%) | 32 (23%) |
| Other | 6 (12%) | 11 (14%) | 17 (13%) |
| Marital status | |||
| Single | 9 (17%) | 13 (16%) | 22 (15%) |
| Married | 38 (74%) | 64 (72%) | 102 (73%) |
| Widowed | 4 (7%) | 11 (12%) | 15 (12%) |
3.2. Patient characteristics
Of the 139 patients (mean age, 72.8 ± 7.1 years) included in the analysis, 70% were males. In the minor amputation group, the mean age of the 51 patients (32 men and 19 women) was 72.1 years. In the major amputation group, the mean age of the 88 patients (62 men and 16 women) was 73.7 years. There was no significant difference between the groups in terms of patient age (P = .71). The major amputation group consisted of 32 patients with above‐knee amputation and 56 patients with below‐knee amputation. Mean length of hospital stay at study baseline was 17.7 ± 6.1 days (Table 1).
3.3. Primary outcome: caregiver burden
The mean preoperative ZBI value was 32.5 ± 9.1 (range, 16‐36) in the major amputation group and 21.1 ± 7.5 (range, 6‐32) in the minor amputation group; there were significant differences between both groups (P: 0 < .01). The mean ZBI value at 3 months postoperatively was 19.68 ± 6.2 (range, 8‐28) and 11.2 ± 5.1 (range, 2‐21) in the major and minor amputation groups, respectively, with a significant difference between both groups (P: 0 < .01). The mean ZBI point at 6 months postoperatively was 13.1 ± 3.2 (range, 6‐19) and 4.1 ± 1.9 (range, 0‐8) in the major and minor amputation groups, respectively, with significant differences between both groups (P: 0 < .01) (Table 2).
Table 2.
Comparison of Zarit Burden Interview‐12 results between both groups
| Patients with minor amputations | Patients with major amputations | ||||
|---|---|---|---|---|---|
| Mean ± SD | Min‐Max | Mean ± SD | Min‐Max | P value | |
| Preoperative | 21.1 ± 7.5 | 6‐32 | 32.5 ± 9.1 | 16‐36 | .001 |
| 3‐month follow‐up | 11.2 ± 5.1 | 2‐21 | 19.68 ± 6.2 | 8‐28 | .001 |
| 6‐month follow‐up | 4.1 ± 1.9 | 0‐8 | 13.1 ± 3.2 | 6‐19 | .001 |
Abbreviations: Min, minimum; Max, maximum.
Patients in both minor and major amputation groups showed a significant improvement in the ZBI value preoperatively and at 3‐ and 6‐month follow‐up visits.
There was no significant difference in caregiver burden between the above‐ and below‐knee amputations. However, the caregiver ZBI score was higher in the above‐knee group than in the below‐knee group (Table 3).
Table 3.
Comparison of Zarit Burden Interview‐12 results between below‐ and above‐knee amputations
| Patients with above‐knee amputations (n = 32) | Patients with below‐knee amputations (n = 56) | ||||
|---|---|---|---|---|---|
| Mean ± SD | Min‐Max | Mean ± SD | Min‐Max | P value | |
| Preoperative | 34.1 ± 5.4 | 20‐36 | 30.7 ± 6.1 | 16‐32 | .21 |
| 3‐month follow‐up | 22.4 ± 6.2 | 12‐28 | 17.1 ± 6.9 | 5‐22 | .09 |
| 6‐month follow‐up | 15.2 ± 3.1 | 8‐19 | 11.8 ± 3.7 | 6‐14 | .12 |
Abbreviations: Min, minimum; Max, maximum.
4. DISCUSSION
The specific burden associated with diabetes is important for the caregiver because of requirements of complex care for patients with diabetes. Caring for a family member with chronic diabetic foot wound has been confirmed as being a source of burden that involves social, psychological, physical, emotional, and practical challenges. In the present study, we investigated and compared the status of caregiver burden in patients with diabetic foot wound pre‐ and postoperatively. Lower extremity amputation for the treatment of diabetic foot ulcers has a favourable effect on caregiver burden regardless of the level of amputation.
Several studies have investigated caregiving burden of individuals caring for patients with diabetic foot wounds.11, 12, 13 Yazla et al investigated and compared the levels of the caregiving burden of individuals caring for patients with diabetic foot, with psychotic disorder, and with inguinal hernia; they considered the caregivers of patients with inguinal hernia as the control group.12 In that study, 30 hospital inpatients with diabetic foot, 30 with psychotic disorder, and 30 with inguinal hernia were included. The evaluations were conducted based on the voluntary completion of the ZBI form, Beck Depression scale, Beck Anxiety scale, Hospital Anxiety and Depression scale, and Short Form‐36 (SF‐36) scales. They found that the depression and anxiety scale scores of the diabetic foot group were significantly higher than those of the control and psychotic groups, and some aspects of the Quality of Life Scale were determined to be significantly low in caregivers of patients with diabetes. A correlation between the duration of caregiving and burden was only determined in the diabetic foot group. Another study by Nabuurs‐Franssen et al investigated and determined the impact of healing of a foot ulcer on the quality of life in patients with diabetes and their caregivers.13 In their study, the quality of life determined according to the 36‐item health‐related quality of life questionnaire (SF‐36) of 294 patients (ulcer duration ≥4 weeks) and 153 caregivers was analysed at baseline, when the ulcer was healed and at 3 months later. At the end of this study, there were 162 patients with a healed ulcer and 132 patients with persistent ulcer. The study reported that there were no differences in the quality of life at the initiation of the study between the caregivers of patients with healed ulcer and persistent ulcer. At the end of the follow‐up period, the quality of life was markedly higher in the caregivers of patients with healed ulcer than in those of patients with persistent ulcer, which changes gradually; the quality of life improved for the caregivers of patients with healed ulcer and worsened for caregivers of patients with persistent ulcers. In the present study, we found that the caregiving burden of individuals caring for patients with major amputation was significantly higher than that of the minor amputation group pre‐ and postoperatively. However, caregiving burden was significantly decreased for both groups at 3 and 6 months postoperatively.
The treatment of diabetic foot wound has a substantial burden on the patients as well as on their caregivers.13, 14 In particular, healing was associated with a considerable improvement in the quality of life related to emotional challenges experienced by the caregivers. Moreover, caregiver burden was correlated with the life status of the patients. Several factors are probably responsible for the loss of quality of life of the caregivers, such as wound care, impaired mobility, frequent hospital visits, fear of amputation, concordance of life after amputation, and usage of prosthetic device. Ojoawo et al investigated and compared the caregiving burden among informal caregivers of individuals with different levels of amputation.15 In their study, involving 66 individuals with amputation and their caregivers, the ZBI form was used to assess the caregiver burden. They found a slightly more‐than‐average but significantly higher score for females than for males, and that the caregiver burden was the highest in cases of above‐knee amputations and the lowest in cases of below‐knee amputations.
Previous studies investigating different short versions of the ZBI in caregivers of patients with cancer, dementia, and brain injuries found that the 12‐item version had the greatest validity and consistency and suggested a cut‐off of 12 points for high burden.16, 17, 18 Another study by Gratão et al suggested that the cut‐off point for the ZBI‐12 for community‐dwelling older caregivers was 13 points.18 The first study involving the development of the ZBI‐12 included caregivers of older patients, of whom most patients had dementia. A cut‐off point of 17 was determined.10 In our study, all caregivers had a higher burden preoperatively, which was higher than the cut‐off point; however, the ZBI was decreased in all groups. In particular, caregivers of patients with minor amputations had a ZBI score lesser than the cut‐off point. Although ZBI scores in the major amputation group significantly decreased postoperatively, they remained higher than the cut‐off point. However, it must be noted that the cut‐off point of ZBI score was not determined for caregivers of patients with diabetes. Differences in the care context and populations may contribute to different degrees of caregiver burden. Further studies are required to establish a cut‐off point for the evaluation of burden using the ZBI‐12.
The present study had some limitations: the sex, educational levels, and income of the caregiver groups were not homogeneous. A priori sample size calculation was not performed. Furthermore, the data can be considered to be the caregivers of patients with chronic diseases that affect their burden. Another limitation was the relatively short follow‐up period of 6 months.
5. CONCLUSION
This is a prospective descriptive study that analyses the effect of amputation level on the caregiving burden of the individuals caring for patients with chronic diabetic foot ulcer. To the best of our knowledge, this is the first study that describes the caregiving burden among the caregivers of patients with diabetic foot wound pre‐ and postoperatively. The absence of ankle joint in the below‐ or above‐knee amputation renders it more challenging for the amputee to quickly learn the use of prosthesis, which increases the burden of the patient and caregivers. In the present study, we found that lower extremity amputation for the treatment of chronic diabetic foot ulcer has significantly favourable effect on the caregiver burden and thereby heel sparing considerably more effective for the caregiver burden.
CONFLICT OF INTEREST
The author(s) declare no potential conflict of interest.
ACKNOWLEDGEMENT
The authors would like to thank Enago (www.enago.com) for the English language review.
Çamur S, Batıbay SG, Bayram S. Effect of lower extremity amputation on caregiving burden in caregivers of patients with diabetic foot: Prospective cohort study. Int Wound J. 2020;17:890–896. 10.1111/iwj.13342
Approval was given by the Institutional Review Board (IRB) and that informed consent was obtained from each patient (12.08.2018).
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