NAFF Arabic Validation Study

December 5, 2025 updated by: Emna Taghouti, Faculty of Medicine, Sousse

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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..

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Sousse Governorate
      • Sousse, Sousse Governorate, Tunisia, 4000
        • Farhat Hached University Hospital, Endocrinology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
01/06/ 2021-31/07/ 2021 (2 months)
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.
01/08/2021 to 28/11/2021 (4 months)
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.
Test-retest interval of 10-14 days between initial assessment and follow-up assessment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the end of data collection
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.
At the end of data collection
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.
At the end of data collection
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.
At the end of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculty of Medicine, Sousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAFF-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly due to ethical constraints and participant privacy protections as per the Ethics Committee approval (CEFMS 81/2021) and Tunisian data protection regulations. Aggregate data and statistical results are available through the published manuscript. Researchers interested in collaboration may contact the principal investigator to discuss potential data sharing arrangements that comply with ethical and regulatory requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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