- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00683020
Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan (SMARTSteps)
Обзор исследования
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94110
- Center for Vulnerable Populations
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diabetes diagnosis
- Attend one of 4 CHNSF clinics
- Ages 18 or above
- Speak English, Spanish or Cantonese
- Have a touch tone phone
- Have had one or more clinic visits in the preceding 24 months
- Will be in the SF Bay Area for the following six months
Exclusion Criteria:
- Pregnant
- Unable to provide verbal consent
- Leaving the region in the next 12 months
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support.
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The ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication. For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients.
Другие имена:
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Без вмешательства: WAIT LIST Control
WAIT LIST Control: six month Wait List.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Changes in the Physical Component Summary of the SF-12 Health Survey
Временное ограничение: Baseline and 6 months
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in the Mental Component Summary of the SF-12 Health Survey
Временное ограничение: Baseline and 6 months
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Number of Days Spent in Bed Due to Illness
Временное ограничение: 6 months
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A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did health problems keep you in bed for all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.
Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported.
A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness).
To calculate the mean, one raises e by the number given as the log mean.
Lower log means indicate better functional status.
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6 months
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Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Временное ограничение: 6 months
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A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?"
Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never".
These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses.
The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
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6 months
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Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Временное ограничение: Baseline and 6 months
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The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors.
The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence.
Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score.
For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged.
For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged.
For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Временное ограничение: Baseline and 6 months
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The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors.
The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence.
Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score.
For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged.
For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged.
For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Временное ограничение: Baseline and 6 months
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The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project.
The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care).
Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested.
Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy.
Total scale score is calculated as the average across all items.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
Временное ограничение: Baseline and 6 months
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The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model.
The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support.
Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care.
Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score.
Higher transformed and total scale scores indicate better care.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
Временное ограничение: Baseline and 6 months
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The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on providers' communication over the prior 6 months.
The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness).
Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Higher total scores indicate better communication.
Change is calculated as 6-month score minus baseline score.
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Baseline and 6 months
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Changes in Hemoglobin A1c Levels
Временное ограничение: Baseline and 6 months
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Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way.
This serves as a marker for average blood glucose levels over the previous months prior to the measurement.
Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease.
Change is calculated as 6-month level minus baseline level.
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Baseline and 6 months
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Changes in Systolic Blood Pressure (SBP)
Временное ограничение: Baseline and 6 months
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Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body.
Change is calculated as 6-month pressure minus baseline pressure.
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Baseline and 6 months
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Changes in Diastolic Blood Pressure (DBP)
Временное ограничение: Baseline and 6 months
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Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood.
Change is calculated as 6-month pressure minus baseline pressure.
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Baseline and 6 months
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Соавторы и исследователи
Следователи
- Главный следователь: Dean Schillinger, MD, University of California, San Francisco
Публикации и полезные ссылки
Общие публикации
- Ratanawongsa N, Quan J, Handley MA, Sarkar U, Schillinger D. Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims. BMC Health Serv Res. 2018 Apr 6;18(1):254. doi: 10.1186/s12913-018-3071-4.
- Quan J, Lee AK, Handley MA, Ratanawongsa N, Sarkar U, Tseng S, Schillinger D. Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis. Popul Health Manag. 2015 Dec;18(6):412-20. doi: 10.1089/pop.2014.0154. Epub 2015 Jun 23.
- Ratanawongsa N, Handley MA, Quan J, Sarkar U, Pfeifer K, Soria C, Schillinger D. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol. BMC Health Serv Res. 2012 Jan 26;12:22. doi: 10.1186/1472-6963-12-22.
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
Другие идентификационные номера исследования
- R18HS017261 (Грант/контракт AHRQ США)
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. .
Клинические исследования ATSM Intervention
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Brigham and Women's HospitalNational Institute on Aging (NIA)ЗавершенныйРевматические заболевания | Красная волчанка, системная | Приверженность, лекарства | ПодаграСоединенные Штаты
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Meghan MarsacChildren's Hospital of PhiladelphiaЗавершенный
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Seton Healthcare FamilyUniversity of Texas at AustinЗавершенныйКачество жизни | Хроническое заболевание | Хроническое заболеваниеСоединенные Штаты
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University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)РекрутингДоконтактная профилактика ВИЧСоединенные Штаты
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University Medical Center GroningenGGZ Drenthe Mental Health InstitutionРекрутингСердечно-сосудистый риск | Депрессия, униполярная | Депрессия, биполярное расстройствоНидерланды
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Hospital Clinic of BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer; University of BarcelonaЗавершенныйЗаболевания печени | Неалкогольная жировая болезнь печени | Образ жизни, ЗдоровыйИспания
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Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute... и другие соавторыНеизвестныйТравматическое повреждение мозгаСоединенные Штаты
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Duke UniversityNational Institutes of Health (NIH)Еще не набираютПродвинутый рак | Рак желудочно-кишечного тракта
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University of Illinois at ChicagoЗавершенный
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgНеизвестныйИнфаркт головного мозгаГермания