Study protocol: A randomized controlled trial of a community-based intervention on clinical parameters, health literacy, medication adherence, and quality of life among individuals with coexisting diabetes and hypertension

研究方案:一项随机对照试验,旨在评估社区干预措施对合并糖尿病和高血压患者的临床指标、健康素养、药物依从性和生活质量的影响。

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Abstract

BACKGROUND: Diabetes and hypertension are prevalent chronic conditions that often coexist and contribute significantly to morbidity and mortality. Effective management requires patient-centred interventions that integrate lifestyle modification, health education, and self-monitoring. OBJECTIVE: This study aims to evaluate the effectiveness of Community-Based Intervention (CBI) on clinical parameters, health literacy, medication adherence, and quality of life among Individuals with coexisting diabetes and hypertension in urban slum settings. METHODS: A randomized controlled trial (RCT) will be conducted among 120 eligible participants aged between 30-60 years. Participants will be randomly assigned to either the intervention or control group using block randomization (12 blocks, each containing 5 participants per group) with allocation concealment. The intervention group will receive a 6-week CBI consisting of pre-intervention orientation, yoga-based lifestyle modification, nurse-led counseling, and home-based monitoring, in addition to standard care. The control group will receive standard care, with informational materials provided after the intervention period. EXPECTED OUTCOMES: Data on blood sugar, blood pressure, health literacy, medication adherence, and quality of life will be collected at baseline, 2 months, 3 months, and 6 months. The intervention is expected to improve clinical outcomes, enhance health literacy, increase medication adherence, and promote better quality of life.

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