Cross-cultural Adaptation and Validation of the Nottingham Assessment of Functional Footcare (NAFF) Questionnaire Among Arabic-speaking Adults With Diabetes in Tunisia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Translation and adaptation
研究概览
简要总结
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.
详细描述
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..
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 26 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Translation and adaptation
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Criterion Validity - Correlation with Ulceration Risk Stratification(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)
- Internal consistency(At the end of data collection)
研究者
Emna Taghouti
Doctorante, Investigateur Principal
Faculty of Medicine, Sousse