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NCT Number: NCT07591103

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria University Hospital, Faculty of Nursing, Alexandria, Alexandria Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire-based assessment

Other

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 outcomes

  1. Self-management agency

    Time frame: Baseline (cross-sectional assessment)

    The level of self-management agency among adult patients with diabetes mellitus, measured using the adapted Appraisal of Self-Care Agency Scale-Revised (ASAS-R).

Secondary outcomes

  1. Health literacy

    Time frame: At enrollment

    Health literacy levels measured using the adapted All Aspects of Health Literacy Scale (AAHLS), including functional, communicative, and critical domains.

  2. Socio-ecological determinants of diabetes self-management

    Time frame: At enrollment

    Socio-ecological determinants measured across individual, interpersonal, organizational, community, and policy levels using a researcher-developed assessment tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Salem

CONTACT

[email protected]

Mohamed Fakhry Ahmed Salem, phd

CONTACT

[email protected]

+201286038014

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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