- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02445950
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
Обзор исследования
Статус
Условия
Подробное описание
The study focuses on mental well-being. The both interventions include intensive and independent phase.
The intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.
The independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- At least a bachelor level degree
- Age over 18 years
- Decreased psycho-physic state (own assessment)
- Is in a relationship
- Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship
- Willing to use technological wellness coaching tools, familiarity with technology
Exclusion Criteria:
- Work includes night shifts
- Acute health conditions or serious diseases
- Chronical pain affecting functionality
- Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)
- Participation in some other study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Technology-aided counseling
Customers receive intervention via technology-aided phone wellness counseling.
The intensive phase lasts 13 weeks and includes 5 phone calls.
The customers are able to view their change change needs and choose tasks/goals for the coaching.
The independent phase lasts 13 weeks and coaching is done via a digital tool.
|
The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
|
|
Активный компаратор: Traditional counseling
Customers receive intervention via traditional phone wellness counseling.
The intensive phase lasts 13 weeks and includes 5 phone calls.
Change needs and goals are set during the phone calls.
The independent phase lasts 13 weeks and includes 3 phone calls.
|
The intervention provides phone wellness counseling in occupational health.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time used for coaching
Временное ограничение: 6 months
|
Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log.
This is used to evaluate the cost of coaching.
|
6 months
|
|
Psychological wellbeing
Временное ограничение: 6 months
|
Measured by the Työoptimi occupational health questionnaire.
This is used to evaluate the effectiveness of the coaching.
|
6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Customer satisfaction for coaching
Временное ограничение: 6 months
|
Measured by ad hoc questionnaires.
|
6 months
|
|
Occupational health
Временное ограничение: 6 months
|
Measured by Työoptimi occupational health questionnaire.
|
6 months
|
|
Satisfaction to life situation
Временное ограничение: 6 months
|
Measured by scale from 1 to 5.
|
6 months
|
|
Self-esteem
Временное ограничение: 6 months
|
Measured by 10-item Rosenberg's Self-Esteem Scale.
|
6 months
|
|
Cognitive fusion
Временное ограничение: 6 months
|
Measured by 7-item Cognitive Fusion Questionnaire
|
6 months
|
|
Perceived stress
Временное ограничение: 6 months
|
Measured by a single-item stress scale.
|
6 months
|
|
Satisfaction to a relationship
Временное ограничение: 6 months
|
The scale is modified from The Family Federation of Finland's quality test of a relationship.
|
6 months
|
|
Activeness in conducting tasks
Временное ограничение: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
|
Carefulness in conducting tasks
Временное ограничение: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
|
Readiness to change
Временное ограничение: 6 months
|
Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
|
6 months
|
|
Lifestyle
Временное ограничение: 6 months
|
Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.
|
6 months
|
|
Number of the changes made to the profile
Временное ограничение: 1 month
|
Data from the profiling database.
|
1 month
|
|
Perceived Accuracy of the profiling tool
Временное ограничение: 1 month
|
Assessed by the coaches via questionnaires.
|
1 month
|
|
Perceived ease of use
Временное ограничение: 6 months
|
Measured by questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
|
Perceived usefulness
Временное ограничение: 6 months
|
Measured by the questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Hannu Nieminen, PhD, Technical University of Denmark
- Главный следователь: Jouni Kaartinen, DSc, VTT Technical Research Centre of Finland Ltd
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 332885 With-Me-Occ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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