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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07591103
Enrollment
400
Registered
2026-05-15
Start date
2026-05-15
Completion date
2026-07-30
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus (Type 1 and Type 2)

Keywords

Diabetes Mellitus, Health Literacy, Self-Management, Socio-Ecological Determinants, Self-Care Agency

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.

Interventions

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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Self-management agencyBaseline (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

MeasureTime frameDescription
Health literacyAt enrollmentHealth literacy levels measured using the adapted All Aspects of Health Literacy Scale (AAHLS), including functional, communicative, and critical domains.
Socio-ecological determinants of diabetes self-managementAt enrollmentSocio-ecological determinants measured across individual, interpersonal, organizational, community, and policy levels using a researcher-developed assessment tool.

Countries

Egypt

Contacts

CONTACTMohamed Fakhry Ahmed Salem, phd
Mohamed.Fakhry@alexu.edu.eg+201286038014
CONTACTAhmed Salem
Mohamed.Fakhry@alexu.edu.eg
PRINCIPAL_INVESTIGATORMohamed Fakhry Ahmed Salem

Alexandria University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026