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

June 4, 2026 updated by: Mohamed Fakhry Ahmed Salem, Alexandria University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 21511
        • Recruiting
        • Alexandria University Hospital, Faculty of Nursing
        • Principal Investigator:
          • Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
        • Contact:
      • Alexandria, Alexandria Governorate, Egypt, 21511
        • Not yet recruiting
        • Faculty of Nursing, Alexandria University
        • Principal Investigator:
          • Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with type 1 or type 2 diabetes mellitus and attending outpatient clinics or primary healthcare centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment
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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Fakhry Ahmed Salem, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 9, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-20-10-463

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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