Abstract
Background: Diabetic foot ulcer (DFU) is a common but preventable complication of diabetes mellitus. Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Self-care education interventions that engage persons with diabetes and their family caregivers have been shown as effective in preventing diabetes- related foot ulcers, yet this has not been evaluated in Africa. It follows that this PhD thesis set out to assess the potential of harnessing the family-centred cultural environment in Ghana to facilitate the prevention of diabetic foot ulcer in Ghana.Aim: The overall aim of the study is to develop a culturally appropriate diabetes-related foot ulcer prevention self-care program involving persons with diabetes and their family caregivers, and test its feasibility, acceptability, and potential efficacy in Ghana.
Methods: Guided by the joint National Institute of Health Research and Medical Research Council framework for developing and evaluating complex interventions, four work packages were conducted. The initial phase of the study, a systematic review (published paper 1), identified types of informal caregiver interventions and their impact in preventing and/or managing diabetes-related foot ulcers. The second and third phases in a reiterative process modified an evidence-based foot-care intervention through a stakeholder engagement, comprising Patient Public Involvement activities in Ghana and qualitative research interviews with key informant nurses (n = 5), persons with diabetes (n = 5) and family caregivers (n = 5). Nurse educators (N = 3) were trained by the researcher to deliver the intervention. In the final phase, 50 dyads (adults at high risk of diabetes-related foot ulcers and their nominated family caregivers) participated in an individually randomised parallel group feasibility trial of the adapted intervention compared to usual care to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Among participants with diabetes, patient reported outcomes were footcare behaviour, foot self-care efficacy and diabetes knowledge assessed using adapted Nottingham Assessment of Functional Foot scale (NAFF), Foot Care Confidence Scale (FCCS) and Diabetes Knowledge Questionnaire (DKQ) respectively. Diabetes distress and diabetes knowledge (DKQ) of caregivers were also assessed using adapted Diabetes Distress Scale for Spouses and Partners (DDS-SP) and DKQ respectively.
Results:
• Following the search of electronic databases during the review, 9275 articles were screened, out of which 10 met the inclusion criteria and consisted of RCTs (n = 5), non-RCTs (n = 1), and Pre-post studies (n = 4). The review found that engaging both persons with diabetes and their informal caregivers in healthcare programs strengthened selfcare interventions that resulted in improved diabetes self- management and clinical outcomes. Family caregivers acted as surrogate healthcare providers at home. Caregivers were engaged in diverse roles ranging from practical engagement in daily foot checks and wound care to collaborative setting of diabetes/foot care goals and problem solving. Despite the heterogenous nature of behavioural, psychological, and educational interventions identified in the review, engaging the dyad (caregivers and person with diabetes) in in-person education and hands-on skills training on wound care and foot checks were distinctive characteristics of interventions that consistently produced improved foot self-care behaviour and clinically significant improvement in wound healing. The review identified an evidence gap in the literature, highlighting the dearth of studies from African settings suggesting the potential viability of caregiver involved footcare interventions in Ghana. Nevertheless, the study identified footcare intervention components that could be contextualised and evaluated in lower resource settings where the involvement of knowledgeable, skilled and confident caregivers could reap significant benefits to their family and community in the absence of access to high quality healthcare for people with and/or at risk of diabetic foot disease. Therefore, the identified intervention components were taken to the next phase of the study to be assessed for their contextual utility in Ghana.
• A patient and public involvement and stakeholders (PPI/S) activity in Ghana modified an evidence-based intervention that reflected the literacy and information needs of persons with diabetes in Ghana without altering the core component of the original intervention. This resulted in a context appropriate diabetic foot self-care intervention curriculum that uses easy to do footcare skills training and education for persons with diabetes and nominated family caregivers with the aim of enhancing their knowledge, skills and confidence in footcare.
• Key informant research participants were positive regarding the content, relevance, acceptability, and practical educational approaches adopted (including skills demonstrations) in the intervention. There was less consensus regarding the optimal method of intervention delivery (remote versus face to face). Also, systemic factors of human resource limitations and patient/caregiver limited time to engage in face-to- face intervention sessions were identified, and these related to implementation science framework tenets in a manner that can impede upscaling efforts of the intervention if not addressed. Nurse participants were not diabetes specialists, and they suggested the need for educator (nurse providers) training to implement the intervention. The key informant interviews concluded with identified nurse training needs and intervention curriculum that is interactive, engaging and used self-efficacy enhancing mechanisms in its content curation and delivery, reflecting the theoretical basis of the behavioural intervention.
• The feasibility trial successfully recruited, randomised, and delivered the intervention to participating dyads (N = 50) as planned. Thus, the trial’s predetermined study protocol and intervention feasibility targets on recruitment, retention and intervention delivery fidelity were met. At 12-weeks post randomisation, efficacy signals favoured the intervention group on greater NAFF, FCC, and DKQ scores with a mean difference between intervention and control groups being 10.16 (95% C.I. 7.66, 12.67), 8.27(95% C.I. 5.87, 10.68) and 1.44(95% C.I. 0.78, 2.09) respectively for persons with diabetes. The effect size was large with a Cohen's d above 1 for each of the outcomes. Similar changes favouring family caregivers in the intervention group were observed on DDS-SP and DKQ with a mean difference of -12.59 (95% C.I. - 16.91, -8.27) and 1.34(95% C.I. 0.84, 1.83) respectively. However, these efficacy signals are being interpreted with caution in the face of some study limitations including the inadequate internal reliability of NAFF following its adaptation for the study context. In the feasibility trial, healthcare workers (nurses, n = 3) trained on the intervention and given protected time were able to deliver the intervention appropriately. However, participants wanted more information and discussion on caregiver roles. The nurse providers also struggle to effectively engage reluctant dyads who will not volunteer to carry out redemonstration of taught footcare skills. Despite these challenges, they found it to be feasible to deliver the intervention per protocol.
Conclusion: Delivering feasible diabetes-related foot ulcer prevention services, which include a role for patient and family education and training on footcare and reportable signs and symptoms could improve DFU occurrence. This contextual family-oriented foot self- care education is feasible in Ghana and may improve self-care and self-efficacy with the potential to decrease diabetes-related complications. An effectiveness trial of the intervention is feasible, but the primary outcome and patient reported outcome measure remain an uncertainty due to unconfirmed contextual validity of some outcome measures that requires further exploration. Future studies should explore the potential of adapting some or all the intervention for remote delivery to fit the busy work schedules of patients and caregivers and lessen staff burden.
Date of Award | 1 Oct 2024 |
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Original language | English |
Awarding Institution |
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Supervisor | Jackie Sturt (Supervisor) & Kirsty Winkley (Supervisor) |