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

Observational Diabetes Mellitus (Type 1 and Type 2)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire-based assessment.
Who it may be relevant to
Registry conditions: Diabetes Mellitus (Type 1 and Type 2). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Questionnaire-based assessment
    No clinical or behavioral intervention is applied. This observational study involves a questionnaire-based assessment to collect data on socio-ecological determinants, health literacy, and self-management agency among adult patients with diabetes mellitus.

Primary outcome measures

  • Self-management agency [Time frame: Baseline (cross-sectional assessment)]
Secondary outcome measures (2)
  • Health literacy [Time frame: At enrollment]
  • Socio-ecological determinants of diabetes self-management [Time frame: At enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Egypt · 2 centers
  • Alexandria University Hospital, Faculty of Nursing — Alexandria
  • Faculty of Nursing, Alexandria University — Alexandria

Identifiers

NCT: NCT07591103 · AU-20-10-463

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗