ISRCTN17123528已完成未知
A COVID-19 pandemic adapted framework for international collaboration on the cross-cultural translation of questionnaires on quality of life, disability, stigma, self-esteem, and wealth into Kinyarwanda using a mixed multistep approach with early involvement of patients living with epilepsy and healthy volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
入排标准
- 性别
- All
入选标准
- •A) Patients with epilepsy (N=2) included in panel discussions
- •1. Definite clinical diagnosis of epilepsy, defined as two epileptic seizures, unprovoked, with a minimum interval of 24 hours
- •2. Able to read self-administered questionnaires and able to write
- •3. Bilingual English and Kinyarwanda, preferably trilingual French, English, Kinyarwanda
- •4. Able to attend/complete computer-assisted personal interviewing
- •5. Willing to attend video conferencing and CASI
- •6. = 18y of age
- •7. Providing signed informed consent
- •B) Healthy volunteers (N=2) included in panel discussions
- •1. Able to read
- •2. = 18y of age
- •3. Willing to attend video conferencing and CASI
- •4. Provide signed informed consent
- •C) Volunteers (N=30) enrolled for assessment of similarity/comparability of the original version (OV) and Back translation (BT)
- •1. Fluent in English
- •2. Able to attend/complete CASI
- •3. = 18y of age
- •4. Providing signed informed consent
- •D) Patients (N=5) for testing of prefinal version
- •1. Definite clinical diagnosis of epilepsy, defined as two epileptic seizures, unprovoked, with a minimum interval of 24 hours
- •2. Able to understand and respond to the questionnaire
- •3. = 18y of age
- •4. Provide signed informed consent
- •E) Healthy Volunteers (N=5) for testing of prefinal version
- •1. Able to understand and respond to the questionnaire
- •2. = 18y of age
- •3. Provide signed informed consent
- •F) Healthcare Professional (N=5) for testing of prefinal version
- •1. = 18y of age
- •2. Board-certified healthcare professional in Rwanda
- •3. Fluent in Kinyarwanda
- •4. Provide signed informed consent
排除标准
- •A) PwE (N=2) included in panel discussions
- •1. Presence of cognitive deficit hampering interview, comprehension of questions
- •2. Presence of neurological deficit that hinders answering of questions, reading, or understanding
- •3. Presence of hallucinations, psychosis
- •B) HVs (N=2) included in panel discussions
- •1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator
- •2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions,
- •3. Presence of hallucinations, psychosis
- •C) volunteers (N=30) enrolled for assessment of similarity/comparability of the original version (OV) and Back translation (BT)
- •1. Presence of physical condition hampering reading, understanding or answering
- •2. Presence of hallucinations, psychosis
- •D) Patients (N=5) for testing of prefinal version
- •1. Presence of cognitive deficit hampering interview, comprehension of questions
- •2. Presence of neurological deficit that hinders answering of questions, reading or understanding
- •3. Presence of hallucinations, psychosis
- •E) Healthy Volunteers (N=5) for testing of prefinal version
- •1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator
- •2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions,
- •3. Presence of hallucinations, psychosis
- •F) Healthcare Profession (N=5) for testing of prefinal version
- •1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator
- •2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions
研究者
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