Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
24 июня 2021 г. обновлено: Wake Forest University Health Sciences
Web-based Pain Self-Management: Nurse-Guided
To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting.
Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period.
To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique.
The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables.
Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible.
If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina.
Wake Baptist may also develop its own web-based CBT for commercial use.
Тип исследования
Интервенционный
Регистрация (Действительный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
North Carolina
-
Winston-Salem, North Carolina, Соединенные Штаты, 27104
- Wake Forest Baptist Health
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria: -
- patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
- at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
- at least 18 years of age;
- reliable phone (landline or cell), and
- have home computer with reliable internet access.
Exclusion Criteria:
- planned elective surgery during the study period;
- very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
- ongoing unresolved disability claims;
- inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
- cancer-related musculoskeletal pain;
- history of bipolar disorder or schizophrenia; and
- takes daily opioid for more than one year.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Telephone Contact (Nurse)
6 regular telephone contacts by nurses who will use a motivational interviewing technique
|
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
|
|
Активный компаратор: E-mail contact
6 computer generated email reminders (control arm) over an 8-week period.
|
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
Временное ограничение: Up to Week 16
|
Questionnaire that measures subject pain intensity.
The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
|
Up to Week 16
|
|
PROMIS Pain Interference
Временное ограничение: Up to Week 16
|
PROMIS pain interference is a questionnaire that measures interference of pain on subject's life.
The possible raw score range is 6-30.
The raw score has been converted into a T score.
The T score range is from 41.6 to 75.6.
A t-score indicates the number of standard deviations away from the mean.
A t-score of 50 is equal to the mean of a reference population.
Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population.
|
Up to Week 16
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Completed Phone Calls
Временное ограничение: Up to Week 16
|
The number of completed phone calls by the nurse will be recorded.
|
Up to Week 16
|
|
Completed Learning Modules Per Treatment Arm
Временное ограничение: Week 16
|
The number of completed learning modules per treatment arm will be recorded.
|
Week 16
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Subjects With Interest in Pain Self-management
Временное ограничение: Up to Week 16
|
This refers to the acceptability a subject has to pain self management.
This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?"
|
Up to Week 16
|
|
Proportion of Patients Who Viewed Educational Video
Временное ограничение: Up to Week 16
|
This refers to the acceptability a subject has to watching the educational video on web-based CBT.
This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (EMMI) divided by the number of patients who received the video from EMMI.
|
Up to Week 16
|
|
Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.
Временное ограничение: Up to Week 16
|
This refers to the acceptability a subject has to participating in the study.
This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video.
|
Up to Week 16
|
|
Ratings of Perceived Disruption
Временное ограничение: Up to Week 16
|
This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures
|
Up to Week 16
|
|
Uptake Rates
Временное ограничение: Up to Week 16
|
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program.
For the uptake rate, the number of times participants log in to web-based CBT will be recorded.
|
Up to Week 16
|
|
Self-report Frequency of Practicing Pain Coping Skills
Временное ограничение: Up to Week 16
|
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program.
Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5.
Higher scores denote better outcomes.
|
Up to Week 16
|
|
Participant Overall Satisfaction on Web-based CBT Program
Временное ограничение: Up to Week 16
|
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program.
Recorded in a question - scale 0-5.
Higher scores denote better outcomes.
|
Up to Week 16
|
|
Nurse's Time
Временное ограничение: Up to Week 16
|
This refers to the feasibility of the web-based CBT program.
The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded.
|
Up to Week 16
|
|
Perceived Work Rating
Временное ограничение: Up to Week 16
|
This refers to the feasibility of the web-based CBT program.
Nurses will rate perceived additional work load.
Recorded using sing a scale 1-5, higher scores denotes worse outcomes.
|
Up to Week 16
|
|
Motivational Interviewing Treatment Integrity (MITI) Scale
Временное ограничение: Up to Week 16
|
This refers to the feasibility of the web-based CBT program.
This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI).
|
Up to Week 16
|
|
Mean Opioid Daily Dose
Временное ограничение: Up to Week 16
|
This refers to the burden or utilization of health care in relation to the web-based CBT program.
The mean daily dose of opioids will be recorded for all participants.
|
Up to Week 16
|
|
Non-study Phone Calls
Временное ограничение: Up to Week 16
|
This refers to the burden or utilization of health care in relation to the web-based CBT program.
The number of pain relevant phone calls will be recorded.
|
Up to Week 16
|
|
New Referrals to Other Musculoskeletal-related Specialties
Временное ограничение: Up to Week 16
|
This refers to the burden or utilization of health care in relation to the web-based CBT program.
The number of new referrals to other musculoskeletal-related specialties will be recorded.
|
Up to Week 16
|
|
Number of Emergency Room Visits Related to Pain
Временное ограничение: Up to Week 16
|
This refers to the burden or utilization of health care in relation to the web-based CBT program.
The number of ER visits per subject related to pain will be recorded.
|
Up to Week 16
|
|
PROMIS Physical Health -Fatigue
Временное ограничение: Up to Week 16
|
This is a questionnaire that pertains to subject physical health.
Raw summed score from 4 to 20, where 20 represents severe fatigue.
|
Up to Week 16
|
|
PROMIS Physical Health - Physical Function
Временное ограничение: Up to Week 16
|
This is a questionnaire that pertains to subject physical health.
Raw summed score from 4 to 20, where 20 represents severe physical impairment.
|
Up to Week 16
|
|
PROMIS Physical Health - Sleep-related Impairment
Временное ограничение: Up to Week 16
|
This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment.
|
Up to Week 16
|
|
PROMIS Physical Health- Pain Behavior
Временное ограничение: Up to Week 16
|
This is a questionnaire that pertains to subject physical health.
Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior.
|
Up to Week 16
|
|
PROMIS Social Health
Временное ограничение: Up to Week 16
|
This is a questionnaire that pertains to subject social health.
Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions.
|
Up to Week 16
|
|
Brief Pain Inventory (BPI) Pain Severity
Временное ограничение: Up to Week 16
|
This is a pain severity questionnaire.
BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score.
|
Up to Week 16
|
|
BPI Pain Interference
Временное ограничение: Up to Week 16
|
This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life.
The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items.
|
Up to Week 16
|
|
Pain Catastrophizing Score (PCS)
Временное ограничение: Up to Week 16
|
This questionnaire shows the subject's perceived pain.
The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome.
|
Up to Week 16
|
|
Global Rating of Change (GRoC)
Временное ограничение: Up to Week 16
|
This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed.
The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome.
|
Up to Week 16
|
|
Patient Health Questionnaire Depression Scale (PHQ-8)
Временное ограничение: Up to Week 16
|
A questionnaire that shows patient's level of depression.
Scores can be 0-24, with 0 being the best outcome and 24 being the worst.
A score of 10 or greater is considered major depression.
A score of 20 or more is severe major depression.
|
Up to Week 16
|
|
Generalized Anxiety Disorder (GAD-7)
Временное ограничение: Up to Week 16
|
A questionnaire that shows how much anxiety a subject has.
Scores can be 0-18.
A score of 5-9 means mild anxiety.
A score of 10-14 means moderate anxiety.
A score of 15-18 means severe anxiety.
|
Up to Week 16
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Dennis Ang, MD, Wake Forest University Health Sciences
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
17 июля 2019 г.
Первичное завершение (Действительный)
18 января 2021 г.
Завершение исследования (Действительный)
18 января 2021 г.
Даты регистрации исследования
Первый отправленный
23 апреля 2019 г.
Впервые представлено, что соответствует критериям контроля качества
23 апреля 2019 г.
Первый опубликованный (Действительный)
25 апреля 2019 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 июля 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 июня 2021 г.
Последняя проверка
1 февраля 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00056912
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina.
With assistance from Wake Forest Innovation, Wake Baptist may also develop its own web-based CBT that can be commercialize in the future.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .