Diabetes Mellitus (Type 1 and Type 2)NCT07591103
Socio-Ecological Determinants and Health Literacy: A Path Analysis of Self-Management Agency Among Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus (Type 1 and Type 2), run by Alexandria University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus (Type 1 and Type 2)
- What is being tested?
- Questionnaire-based assessment
- How many people
- 400 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 May 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with type 1 or type 2 diabetes mellitus and attending outpatient clinics or primary healthcare centers.
Who may be able to join
- - 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.
Who cannot join
- - Patients with severe cognitive impairment.
- Patients with acute medical conditions preventing participation.
- Pregnant women diagnosed with gestational diabetes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Salem contact
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria University Hospital, Faculty of Nursing
Alexandria, Alexandria Governorate, 21511
Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing, 01286038014, Mohamed.Fakhry@alexu.edu.eg
Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
- Not yet recruiting
Faculty of Nursing, Alexandria University
Alexandria, Alexandria Governorate, 21511
Mohamed Fakhry Ahmed Salem, phd, 01286038014, Mohamed.Fakhry@alexu.edu.eg
Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus (Type 1 and Type 2)
- Being tested
- Questionnaire-based assessment
- Keywords
- Diabetes Mellitus, Health Literacy, Self-Management, Socio-Ecological Determinants, Self-Care Agency
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire-based assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire-based assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (cross-sectional assessment)
Secondary outcomes (2)
Health literacy
Health literacy levels measured using the adapted All Aspects of Health Literacy Scale (AAHLS), including functional, communicative, and critical domains.
Measured: At enrollment
Socio-ecological determinants of diabetes self-management
Socio-ecological determinants measured across individual, interpersonal, organizational, community, and policy levels using a researcher-developed assessment tool.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 May 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (Type 1 and Type 2)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Fakhry Ahmed Salem, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591103
- Sponsor's protocol ID
- AU-20-10-463
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07591103
- Acronym / sponsor ID
- AU-20-10-463
- Conditions
- Diabetes Mellitus (Type 1 and Type 2)
- Keywords
- Diabetes Mellitus, Health Literacy, Self-Management, Socio-Ecological Determinants, Self-Care Agency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Diabetes Mellitus | – | Other: Questionnaire-based assessmentAdult patients diagnosed with type 1 or type 2 diabetes mellitus receiving outpatient follow-up care and participating in a cross-sectional observational assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with type 1 or type 2 diabetes mellitus and attending outpatient clinics or primary healthcare centers.
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (3 listed)
- - Patients with severe cognitive impairment.
- Patients with acute medical conditions preventing participation.
- Pregnant women diagnosed with gestational diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire-based assessmentNo 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. | Other | Patients with Diabetes Mellitus |
Primary outcome
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).
2 secondary outcomes
Health literacy
Time frame: At enrollment
Socio-ecological determinants of diabetes self-management
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Salem contact
Mohamed Fakhry Ahmed Salem principal investigator
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus (Type 1 and Type 2), run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fakhry Ahmed Salem, phd (+201286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management agency (time frame: Baseline (cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.