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Clinical Trials/NCT07591103
NCT07591103RecruitingNot Applicable

Socio-Ecological Determinants and Health Literacy as Predictors of Self-Management Agency Among Patients With Diabetes Mellitus: A Cross-Sectional Path Analysis Study

Alexandria University2 sites in 1 country400 target enrollmentStarted: May 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
400
Locations
2

Study Overview

Brief Summary

This study aims to examine the relationships between socio-ecological determinants, health literacy, and self-management agency among patients with diabetes mellitus. Using a path analysis framework, the study investigates how multi-level socio-ecological factors and different dimensions of health literacy influence patients' capacity for diabetes self-management. Understanding these pathways will support the development of comprehensive, context-sensitive interventions to improve diabetes outcomes.

Detailed Description

Diabetes mellitus is a chronic condition requiring sustained self-management behaviors influenced by individual capacities, social support systems, healthcare structures, community resources, and health policies. This observational study adopts the Social Ecological Model and Orem's Self-Care Deficit Theory to evaluate the combined effects of socio-ecological determinants and health literacy on self-management agency.

Data will be collected using structured questionnaires, including adapted health literacy and self-care agency scales, along with researcher-developed instruments assessing socio-demographic variables and socio-ecological determinants. Path analysis will be employed to examine direct and indirect relationships among study variables.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • - Adults aged 18 years and older.
  • Diagnosed with type 1 or type 2 diabetes mellitus.
  • Receiving follow-up care in outpatient or primary healthcare settings.
  • Able to communicate verbally and provide informed consent.

Exclusion Criteria

  • - Patients with severe cognitive impairment.
  • Patients with acute medical conditions preventing participation.
  • Pregnant women diagnosed with gestational diabetes.

Arms & Interventions

Patients with Diabetes Mellitus

Adult patients diagnosed with type 1 or type 2 diabetes mellitus receiving outpatient follow-up care and participating in a cross-sectional observational assessment.

Intervention: Questionnaire-based assessment (Other)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Fakhry Ahmed Salem

Lecturer of Medical-Surgical Nursing

Alexandria University

Study Sites (2)

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