Using Technology to Track Pain and Pain-related Outcomes
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
- В протоколе указаны: Navio Mobile App.
- Кому может быть актуально
- Состояния в реестре: Pain, Chronic. Базовые параметры: от 21 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Persistent pain is a public health epidemic. The current protocol seeks to develop technology to aid patients' tracking of patients' pain, medications and pain-related variables. The investigators seek to talk with patients in co-investigator's clinic to solicit feedback, as well as pilot test the technology with pain patients.
Подробное описание
Chronic pain affects over 100 million Americans, costs the US over $630 billion annually, and reduces quality of life. It is among the most clinically challenging and financially burdensome conditions facing clinicians and healthcare organizations. Sleep disturbance is common in chronic pain conditions with some studies reporting a prevalence as high as 70%-88%. Psychiatric disorders, including substance abuse and mood disorders are prevalent in chronic pain and are associated with impairment and decreased quality of life. Sleep is increasingly recognized as a critical regulator of mental health. Taken together, epidemiological, cross-sectional, and prospective studies support the hypothesis that insomnia, chronic pain, and depression are mutually interacting, each increasing the risk for the emergence and/or exacerbation of the other. The gold standard of chronic pain management is multidisciplinary pain treatment (MPT), but patients rarely receive MPT secondary to limited access and a severe shortage of pain management specialists. Thus, there is an urgent need for empirically supported, cost-effective multidisciplinary pain self-management options that are accessible to patients and trusted by primary and tertiary care providers. To address this problem, the investigators' group in collaboration with the Johns Hopkins Technology Innovation Center (TIC) has developed a mobile chronic pain, medication and symptom tracking digital technology platform designed to eventually support multidisciplinary pain treatment by enhancing patient-provider communication and delivering comprehensive, personalized, interactive evidence-based pain management strategies. The investigators' App (version 1.3) is currently able to collect self-report data (i.e., pain; sleep; mood; catastrophizing; stress; pain flares) and continuous, passively collected wearable biosensor data (i.e., heart rate; breathing; sleep; heart rate variability/stress). The investigators propose a prospective, observational proof of concept study to demonstrate feasibility and adherence while establishing the psychometric properties of a mobile pain App and to compare these data with passively collected physiological data and laboratory indices of pain in patients with chronic low back pain (CLBP).
Вмешательства
- Другое Navio Mobile App
Participants will use the Navio Mobile App to track participants' pain and pain treatment
Первичные конечные точки
- Patterns of self-reported clinical Pain [Срок оценки: Up to 2 weeks]
- Patterns of Pain Catastrophizing [Срок оценки: Up to 2 weeks]
- Patterns of Positive Mood [Срок оценки: Up to 2 weeks]
- Patterns of Negative Mood [Срок оценки: Up to 2 weeks]
Вторичные конечные точки (1)
- Patient Adherence as assessed by completion of questionnaire on the app [Срок оценки: Up to 2 weeks]
Критерии участия
Критерии включения
- ≥ 21 years of age
- Pain duration > 3 months
- Average pain level of >3 out of 10 (0=no pain; 10=worst pain imaginable)
- English fluency
- Are not scheduled to undergo any medical procedures during the course of the study
- Have a physician-confirmed medical diagnosis associated with chronic pain
- Are willing to comply with the study protocol and give written informed consent. Patients taking non-narcotic analgesics must be on a stable dose one month prior to participation.
Критерии исключения
- Delirium, dementia, or cognitive impairment (i.e., Mini Mental State Exam score <24)
- Unstable major psychiatric disorder or history of schizophrenia
- Beck Depression Inventory score >30 or report of suicidal ideation
- Active substance abuse;
- Refusal to provide access to relevant medical record information.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Behavioral Medicine Research Lab — Baltimore
Идентификаторы
NCT: NCT04267588 · IRB00196831