Behavior, Diabetic Foot Disease, Questionnaire and Survey, Self Care, Type 2 Diabetes Mellitus (T2DM)
Conditions
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.
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..
Interventions
None listed
Sponsors
Faculty of Medicine, Sousse
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
26 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Translation and adaptation | 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 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Internal consistency | 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. |
| Criterion Validity - Correlation with Ulceration Risk Stratification | 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. |
| Criterion Validity - Correlation with Educational Level | 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. |
| Criterion Validity - Correlation with HbA1c Levels | 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. |
Countries
Tunisia
Outcome results
None listed