Type 2 Diabetes Mellitus (T2DM)NCT07271550
NAFF Arabic Validation Study
An observational study of Type 2 Diabetes Mellitus (T2DM) and Diabetic Foot Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Diabetic Foot Disease, Behavior
- How many people
- 255 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Farhat Hached University Hospital, Endocrinology Department
Sousse, Sousse Governorate, 4000
About this study
Official title: 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.
Read the 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..
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Diabetic Foot Disease, Behavior, Self Care, Questionnaire and Survey
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Test-retest interval of 10-14 days between initial assessment and follow-up assessment.
Secondary outcomes (4)
Internal consistency
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.
Measured: At the end of data collection
Criterion Validity - Correlation with Educational Level
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.
Measured: At the end of data collection
Criterion Validity - Correlation with HbA1c Levels
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.
Measured: At the end of data collection
Criterion Validity - Correlation with Ulceration Risk Stratification
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.
Measured: At the end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emna Taghouti, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271550
- Sponsor's protocol ID
- NAFF-A
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the Nottingham Assessment of Functional Footcare (NAFF) Questionnaire Among Arabic-speaking Adults With Diabetes in Tunisia
- ClinicalTrials.gov ID
- NCT07271550
- Acronym / sponsor ID
- NAFF-A
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Diabetic Foot Disease, Behavior, Self Care, Questionnaire and Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 26 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
4 secondary outcomes
Internal consistency
Time frame: At the end of data collection
Criterion Validity - Correlation with Educational Level
Time frame: At the end of data collection
Criterion Validity - Correlation with HbA1c Levels
Time frame: At the end of data collection
Criterion Validity - Correlation with Ulceration Risk Stratification
Time frame: At the end of data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Diabetic Foot Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation and adaptation (time frame: 01/06/ 2021-31/07/ 2021 (2 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.