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Идёт набор NCT07433764

Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study

Наблюдательное Psychological Well Being

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Psychological Well Being. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Psychometric Validation of Test-Retest Reliability of the WB6Dim Digital Self-Assessment Tool for Well-Being Using a 3-Day Interval Protocol and Contamination Control

Обзор

This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine well-being changes between assessments. Participants complete the 28-item WB6Dim questionnaire at baseline (T1) and again 3 days later (T2). A single contamination control question at T2 identifies participants who experienced a significant life event during the interval; these pairs are excluded from primary ICC analyses and retained for exploratory analyses. An optional third assessment at 9 weeks (T3) provides preliminary exploratory data on sensitivity to change following access to a well-being program. T3 is not part of the primary design.

Подробное описание

The first validation study of the WB6Dim instrument (NCT07301879) established strong internal consistency and convergent validity across N=295 participants. Test-retest reliability was assessed over a 14-day interval on N=92 usable pairs, yielding preliminary ICC estimates ranging from .49 to .77. However, the 14-day interval is methodologically suboptimal for a dynamic monitoring tool: real-life events occurring during two weeks cannot be distinguished from instrument instability, and confidence intervals were wide due to the limited number of pairs.

The present study addresses these limitations through three improvements. First, the interval is reduced to 3 days, substantially reducing contamination risk while avoiding memory-based response bias. Second, a contamination control question is administered at T2 to identify and exclude pairs where a significant life event occurred. Third, the target of N=220 usable pairs produces 95% confidence intervals with maximum width of .20 across all dimensions, meeting the precision threshold for definitive psychometric publication.

Only the 28 WB6Dim items are administered, with no additional gold-standard scales, reducing response burden to approximately 3 minutes per session. Participant matching is performed via email address.

Первичные конечные точки

  • Test-Retest Reliability (ICC) of the WB6Dim Internal Tension Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Sleep and Recovery Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Energy Reservoir Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Self-Esteem Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Emotional Climate Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Cognitive Saturation Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Hyperconnection Dimension [Срок оценки: Day 0 to Day 3]
  • Test-Retest Reliability (ICC) of the WB6Dim Perceived Autonomy Dimension [Срок оценки: Day 0 to Day 3]
Вторичные конечные точки (2)
  • Contamination Rate at T2 [Срок оценки: Day 3]
  • ICC Comparison Between Contamination-Free and Contaminated Pairs [Срок оценки: Day 0 to Day 3]

Критерии участия

Критерии включения

  • Adults aged 18 years or older
  • Able to read and understand French
  • Access to an internet-connected device
  • Willing to complete the WB6Dim questionnaire at T1 and T2
  • Consent to anonymous data collection for research purposes

Критерии исключения

  • Under 18 years of age
  • Unable to read or understand French

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Clover Link — Bandol

Публикации

  • Alitta Q. Validation Study of the WB6Dim Digital Self-Assessment Tool for Well-Being Using Gold-Standard Psychometric Scales. ClinicalTrials.gov NCT07301879. First posted 2025-12-24.

Идентификаторы

NCT: NCT07433764 · WB6Dim-C-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗