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NCT Number: NCT07271550

NAFF Arabic Validation Study

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Foot Disease Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Questionnaire and Survey Self Care

Age range

26 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Farhat Hached University Hospital, Endocrinology Department

Sousse, Sousse Governorate, 4000, Tunisia

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Translation and adaptation

    Time frame: 01/06/ 2021-31/07/ 2021 (2 months)

    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.

  2. Descriptive data

    Time frame: 01/08/2021 to 28/11/2021 (4 months)

    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.

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

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

    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.

Secondary outcomes

  1. Internal consistency

    Time frame: At the end of data collection

    Assessment of internal consistency reliability of the Arabic version of the Nottingham Assessment of Functional Footcare questionnaire using Cronbach's alpha coefficient. Acceptable range is 0.70-0.95, with higher values indicating better internal consistency.

  2. Criterion Validity - Correlation with Educational Level

    Time frame: At the end of data collection

    Spearman's correlation coefficient between NAFF-A total scores and participant educational level (primary, secondary, university). Positive correlation expected based on literature showing higher education associated with better self-care behaviors.

  3. Criterion Validity - Correlation with HbA1c Levels

    Time frame: At the end of data collection

    Spearman's correlation coefficient between NAFF-A total scores and glycated hemoglobin (HbA1c) levels. Negative correlation expected as better foot care behaviors should be associated with better glycemic control.

  4. Criterion Validity - Correlation with Ulceration Risk Stratification

    Time frame: At the end of data collection

    Spearman's correlation coefficient between NAFF-A total scores and ulceration risk grades (0-3 scale based on IWGDF guidelines). Negative correlation expected as better foot care behaviors should be associated with lower ulceration risk.

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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