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NAFF Arabic Validation Study | Clinical Trials | Clareo Health

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NAFF Arabic Validation Study

Cross-cultural Adaptation and Validation of the Nottingham Assessment of Functional Footcare (NAFF) Questionnaire Among Arabic-speaking Adults With Diabetes in Tunisia

NCT07271550•Faculty of Medicine, Sousse

View on ClinicalTrials.gov

Summary

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

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..

Eligibility

Age

26 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Farhat Hached University Hospital, Endocrinology Department

Sousse, Sousse Governorate, Tunisia

Key Dates

Start Date

June 1, 2021

Primary Completion Date

November 30, 2021

Completion Date

November 30, 2021

Last Updated

December 9, 2025

Enrollment

255

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus (T2DM)Diabetic Foot DiseaseBehaviorSelf CareQuestionnaire and Survey

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NAFF Arabic Validation Study

Inclusion Criteria

Exclusion Criteria

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Feasibility of a Tailored Online Self-compassion Intervention

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