NAFF Arabic Validation Study

NCT07271550 | Completed

• 1 other identifier: NAFF-A
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Translation and adaptation

  Translation, cultural adaptation, and assessment of content validity through expert panel evaluation using a 4-point relevance scale. Content validity index calculated by dividing items rated 3-4 by total items (n=29). Values ≥0.80 considered acceptable.

  01/06/ 2021-31/07/ 2021 (2 months)

• Descriptive data

  Participants were asked to complete the NAFF-A questionnaire in the waiting room before clinical consultation. Demographic and clinical data were collected from medical records in collaboration with attending physicians, including gender, age, educational level, residence, diabetes duration, HbA1c levels, and history of ulceration or amputation.

  01/08/2021 to 28/11/2021 (4 months)

• Test-Retest Reliability of NAFF-A (Intraclass Correlation Coefficient)

  Assessment of temporal stability of the NAFF-A using intraclass correlation coefficient (ICC) between test and retest administrations. Values ≥0.70 indicate good reliability, with higher values indicating better temporal stability.

  Test-retest interval of 10-14 days between initial assessment and follow-up assessment.

Secondary Outcomes (4)

• Internal consistency

  At the end of data collection

• Criterion Validity - Correlation with Educational Level

  At the end of data collection

• Criterion Validity - Correlation with HbA1c Levels

  At the end of data collection

• Criterion Validity - Correlation with Ulceration Risk Stratification

  At the end of data collection

Eligibility Criteria

• Age: 26 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Farhat Hached University Hospital, Endocrinology Department

Sousse, Sousse Governorate, 4000, Tunisia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorante, Investigateur Principal

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: December 9, 2025
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)