Family-centered training and counselling for enhancing foot self-care knowledge and practices towards prevention of diabetes foot – a randomized controlled trial in urban Jodhpur | BMC Public Health

Diabetes is a lifestyle disease needing lifetime treatment and a significant portion of it involves behaviour/lifestyle modification through selfcare. Literature shown that intervention to the person with diabetes could achieve increase in foot care practices only to a certain level and there is a potential opportunity to involve family to further enhance level of the practices [15]. This study was planned considering the potential role of family involvement in diabetes foot care and selfcare practices which could positively influence diabetes foot outcomes. While there are existing studies related to family involvement in diabetes care, they focus on glycaemic control, diabetes knowledge and summary of diabetes selfcare activities [16,17,18]. They do not focus on the specific aspect of foot care, highlighting a gap in the literature that our study aims to address. Current study may possibly be one of the initial efforts for assessing the effectiveness of family centered intervention in improvement of foot care practice in diabetes.

Strengthening the family in its capacity to prevent and manage diabetes and its complications is one of the resolutions mentioned in the Ahmedabad Declaration of 2018 (Research Society for Study of Diabetes India) in line with the theme for World Diabetes Day 2018 and 2019 [19]. In our study, two family members were included to make the intervention uniform and feasible and were nominated by person with diabetes to enable autonomy and better family support based on existing dynamics, as the focus of our intervention was to establish family support for foot care practices through improvement in awareness among family members. The family-centered care used in this study is supported by the recommendations of various agencies, including the International Working Group on the Diabetic Foot (IWGDF), International Diabetes Federation (IDF) and World Health Organization (WHO) to include family members in diabetes care [8, 20]. In our study, the family intervention emphasised not only health education but also counselling for identification and solving the challenges related to foot care in diabetes and providing family support. Intervention module was designed to provide a comprehensive health education package delivered through the integration of multiple strategies that were proven to be effective in published literature.

Due to the lack of a uniform scale to measure outcomes, we have adopted the scales used in a study conducted in the same country (India), which was prepared based on foot care practices advised by ADA and NDEP (National Diabetes Education Program) [10]. We added extra items to the questionnaire, which helped us explore changes in additional components of foot care practices. The family support questionnaire by La Greca AM et al. with addition of items related to foot care, gave advantage of understanding the pattern of change in family support and perceived supportiveness after family-centered health education in the context of foot care in diabetes [13].

In this study, the sample size was determined based on foot care knowledge, which may limit the power to detect changes in practice or clinical outcomes. However, literature indicates that there is a strong correlation between knowledge of foot care and the implementation of proper practices, with higher levels of knowledge being associated with better foot care practices [21]. By improving knowledge regarding foot care practices, individuals with diabetes become more aware of the condition and it facilitates positive behaviour that could potentially reduce the foot complications. A clear definition of the amount of knowledge changes necessary to result in meaningful improvements in foot care practices or health outcomes is lacking, as methodologies and outcome measures vary across previous studies. Therefore, in this study, we compared both knowledge scores and foot care practice scores to better understand the impacts of intervention.

We have recruited individuals with diabetes of 18 to 60 years of age to find the effectiveness of family intervention among functionally independent individuals. We excluded the dependent population (children, adolescents, and old age) from our study as our focus was enabling family support for foot care which differs from concept of ‘caregiving’. In our study, majority of the participants were female because the same pattern was seen in sampling frame. This trend may be attributed to the fact that many men in this locality are unable to visit NCD clinic during regular working hours due to job commitments and they often prefer seeking medical care from private clinics or general practitioners, which offer more flexible hours beyond standard work times. There was high fidelity of the intervention as single investigator provided the intervention and all participants, persons with diabetes and family members, attended both the health education sessions without any loss to follow up. The family support questionnaire was also useful in assessing the intervention fidelity.

In this study, family-centered training and counselling was effective in improving foot care knowledge and practices among people with diabetes compared to OPD-based care without involvement of the family members. The knowledge of family members has a role in specific support for diabetes care, which can affect the adherence to self-care behaviour by person with diabetes. More knowledge in family members regarding diabetes is associated with higher perceived diabetes-specific family supportive behaviours.

During initial assessment, the perceived diabetes specific support for foot care was negligible in both groups and this might be due to lack of awareness among family members regarding foot care practices in diabetes (reflected as low baseline knowledge score). Lack of awareness was reported as a challenge for providing support in foot care practice by majority of the family members at baseline. Many family members opined that the relevance or method of foot care to person with diabetes were not conveyed to them. Even though they had knowledge regarding medication, diet, exercise, and regular follow up, foot care in diabetes was a relatively new concept to majority of them. Perceived supportiveness was seen only in intervention group at endline and the change was very evident as baseline family support was very poor in most of the items. Apart from regular reminders and motivations for foot care, the reported role of family members in making ‘foot care kit’ like buying items for kit, refilling/replacing the items, assembling them together in a bag, keeping it safe and providing the kit for foot care highlights the novel areas of family support.

During the intervention delivery, it was challenging to schedule sessions where the person with diabetes and two family members could be present together, as they often had conflicting work schedules during weekdays. As a result, the investigator had to accommodate flexible appointments to ensure their availability through multiple home visits. COVID pandemic was another challenge during the study and it was tackled by optimising the methodology. The end-line data collection was done by fixing appointments with participants, taking all precautions, and maintaining social distance. The attrition was very less and comparable in both group in current study. For primary outcome, it was 2.8% (I = 1.9% and C = 3.7%) and 6.5% for clinical assessment (I = 5.5% and C = 8.0%) even with ongoing COVID pandemic. The possibility of spillover of intervention to the control group in our study could not be completely ruled out as the participants were recruited from the same healthcare facility and were residing in the same area. Though there were possibilities for spillover of intervention, analysis of the control group revealed no improvement in variables pertaining to family involvement, suggestive of limited contamination.

The possibility of non-controllable confounding variables, including psychological and intellectual (other than education level) characteristics of person with diabetes and family members, and family dynamics affecting the knowledge and practice outcomes could not be excluded as those were not studied. Even though the study was able to capture the incidence of foot ulcer in control group, one limitation of the study is its short duration which was insufficient to assess the long-term effect in preventing foot ulcers (constraints of being a non-funded single field investigator-driven study).

Current study was conducted among people with diabetes, 18 to 60 years old residing in urban area and the results may be generalised to similar settings. We were not able to include the rural population in our study due to feasibility reasons (postgraduate dissertation with time and resource constraints), and our NCD clinic was established in an urban area. Further studies are needed to explore the effectiveness of such interventions in other populations and settings like rural areas. With family systems, a strength of Indian culture and with ongoing emphasis on families as essential allies in health care, families should be considered as the functional unit of healthcare intervention and provision of preventive foot care in diabetes. The role of facilitators, mediators, and challenges for foot care practices and provision of family support for the same can be explored through future studied. In addition, the possible negative impacts of family support and the role of family dynamics need to be studied. The feasibility of provision of family-centered training and counselling, including costs and resources involved, need to be explored through additional studies. Interventions for improving foot care in person with diabetes with no family member or only one family member which is beyond the scope of this study can be explored through future research. When family support is not available, community volunteers, frontline health workers and neighbourhood networks can be potential stakeholders in such intervention [22]. We were unable to include parameters like glycemic control and other complications of diabetes (diagnosed through investigations) in our study due to resource constraints. So, we could not assess their effect on the study outcomes.

From the results of our study, we recommend inclusion of family centered training and counselling for foot care in diabetes as a part of routine diabetes care in primary health care setting. After this study, the inclusion of family-centered intervention on foot care among persons with diabetes attending our outpatient department was appreciated by the beneficiaries and improvement in self-care was noticed.