NAFF Arabic Validation Study

NCT ID: NCT07271550

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-11-30

Brief Summary

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This study aims to evaluate a new Arabic version of the NAFF questionnaire, which measures foot care behaviors in adults with type 2 diabetes. Participants are adults with type 2 diabetes who will complete the questionnaire online. The study will assess how reliable and valid the Arabic version is, helping healthcare providers identify risky foot care behaviors and improve patient education.

Detailed Description

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This study is a cross-sectional validation of the NAFF questionnaire translated into Arabic. Adult patients with type 2 diabetes will be recruited from endocrinology outpatient clinic in Sousse. Participants will complete the Arabic NAFF online. Primary outcomes include assessment of reliability (internal consistency, test-retest) and validity (construct and criterion validity). Secondary outcomes include the relationship between foot care behaviors and demographic or clinical factors. All participants will provide informed consent electronically. The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Sousse. Data will be analyzed using descriptive and inferential statistics to evaluate the psychometric properties of the Arabic NAFF..

Conditions

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Type 2 Diabetes Mellitus (T2DM) Diabetic Foot Disease Behavior Self Care Questionnaire and Survey

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Adults diagnosed with type 2 diabetes mellitus
* Age 26-65 years
* Ability to read and understand Arabic
* Receiving regular follow-up care at the endocrinology outpatient clinic

Exclusion Criteria

* Cognitive impairments affecting comprehension or self-care activities
* Physical disabilities hindering self-care activities
* Presence of active foot ulcers at time of enrollment
* Bilateral lower-limb amputations
Minimum Eligible Age

26 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Medicine, Sousse

OTHER

Sponsor Role lead

Responsible Party

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Emna Taghouti

Doctorante, Investigateur Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Farhat Hached University Hospital, Endocrinology Department

Sousse, Sousse Governorate, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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NAFF-A

Identifier Type: -

Identifier Source: org_study_id

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