Conceptual validation of a family-centered intervention for adults with type 1 and type 2 diabetes mellitus: insights from focus groups with healthcare professionals, patients, and families

Abstract

Background: Diabetes mellitus is a global health challenge requiring sustained self-management. Evidence highlights the role of families in supporting adults with diabetes mellitus, yet many interventions fail to adopt structured, theory-informed, and family-centred approaches. To address this gap, the psychoeducational intervention "Juntos com a Família + Capazes" (Together with Family + Capable) was developed within the Medical Research Council Framework for Complex Interventions, integrating empirical evidence, theoretical models, and stakeholder input. This study conducted a pre-intervention conceptual validation, exploring perspectives of healthcare professionals, adults with Type 1 and Type 2 diabetes mellitus, and family members on its structure, content, and feasibility. Methods: A qualitative descriptive design was applied. Focus groups interviews with healthcare professionals, adults with diabetes mellitus, and family members, were guided by a semi-structured interview guide. Sessions were audio-recorded, transcribed, and analysed using deductive qualitative content analysis with independent manual coding and consensus discussions. Results: Three focus groups were held (n = 19): two with healthcare professionals and one with adults with diabetes and family members, separated due to participant availability and feasibility constraints. Participants critically reflected on the pre-implementation conceptual design of the programme, described as a six-month intervention with a six-month follow-up, structured into seven modules and delivered flexibly across 7-12 sessions. They endorsed the overall structure and content while suggesting refinements to module sequencing and module titles. Participatory strategies, tailored motivational phone calls, and strong family involvement were considered essential for engagement, sustained behavioural change, and feasibility. Analysis revealed both convergent themes and stakeholder-specific perspectives, integrating clinical expertise with lived experience. Conclusions: The "Juntos com a Família + Capazes" programme was conceptually validated, prior to implementation, as a family-centred, theory-informed, and adaptable intervention for adults with diabetes mellitus and their families. This pre-implementation phase enables refinements to content, sequencing, language, and delivery strategies, strengthening cultural relevance, acceptability, and feasibility. Conducting conceptual validation before piloting ensured that both clinical expertise and lived experiences shaped the intervention, highlighting the value of focus groups in identifying adjustments that enhance its real-world applicability. Future research should evaluate its effectiveness, sustainability, and scalability across healthcare contexts.