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

NCT07591103 | Not Yet Recruiting

• 1 other identifier: AI-IRB00013620DM
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus (Type 1 and Type 2)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self-management agency

  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 Outcomes (2)

• Health literacy

  At enrollment

• Socio-ecological determinants of diabetes self-management

  At enrollment

Study Arms (1)

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

Interventions

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.

Patients with Diabetes Mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, 21511, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohamed Fakhry Ahmed Salem

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Fakhry Ahmed Salem, phd

CONTACT

+201286038014; Mohamed.Fakhry@alexu.edu.eg

Ahmed Salem

CONTACT

Mohamed.Fakhry@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Medical-Surgical Nursing

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 15, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

EG (1)