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To examine the associations among diabetes-related stress, treatment adherence, perceived social support, and health-related quality of life (HRQoL) in adults with type 1 diabetes mellitus (DM1), and to explore the mediating roles of support and adherence in this relationship.
A cross-sectional observational study using self-report standardised measures and mediation analysis.
A total of 772 Spanish adults with DM1 completed validated instruments measuring diabetes-related distress, perceived social support, treatment adherence, and HRQoL. Hierarchical multiple regression and serial mediation analysis (PROCESS Model 6, 10,000 bootstraps) were conducted, controlling for age, sex, and time since diagnosis.
Not applicable (primary data collection, not a review).
Diabetes-related stress was the strongest predictor of lower HRQoL. Perceived social support and treatment adherence also contributed significantly. Mediation analyses indicated that the impact of stress on HRQoL was partially mediated by perceived social support and, in sequence, by treatment adherence. The indirect path through social support alone and the sequential path involving both mediators were significant.
Stress and social support are critical in understanding and improving HRQoL in adults with DM1. Treatment adherence appears to be influenced by perceived support, highlighting an indirect mechanism linking stress to quality of life.
Healthcare professionals should integrate psychosocial assessments and interventions into routine diabetes care. Targeting stress reduction and enhancing social support may improve adherence and overall well-being in adults with DM1.
What problem did the study address? The study addressed the need to understand how psychosocial factors—specifically stress, perceived social support, and treatment adherence—contribute to HRQoL in adults with DM1. While prior research often focused on paediatric or clinical populations and rarely explored mediation models, this study sought to fill those gaps with data from a large community sample of adults.
What were the main findings? The main findings indicate that diabetes-related stress is the most significant predictor of reduced HRQoL. This relationship is partially mediated by perceived social support and, sequentially, by treatment adherence. While stress directly affects HRQoL, its negative impact is also channelled through diminished social support and decreased adherence. The indirect effect through treatment adherence alone was not significant.
Where and on whom will the research have an impact? The research has implications for adults living with DM1, particularly those in community settings outside of clinical supervision. It informs healthcare providers, diabetes educators, and policymakers on the importance of addressing emotional distress and strengthening support networks to improve both treatment adherence and overall quality of life.
This study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies. All methods and results are reported in alignment with EQUATOR Network recommendations for transparent and rigorous research reporting.
The study was conducted in collaboration with the Spanish Diabetes Federation (FEDE), which supported participant recruitment and dissemination through its affiliated associations. Patient input was incorporated throughout the study. A person with lived experience of type 1 diabetes contributed to the conceptual development of the research questions and the interpretation of findings. Their perspective helped ensure that the study design, choice of measures, and implications were relevant and meaningful to people living with the condition. This involvement supported a patient-centred approach to both the research and the manuscript preparation. Patients' participation as voluntary contributors was essential to the data collection process.
Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.
A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.
The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.
Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.
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