SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities (SanaMente)
10 июля 2026 г. обновлено: Anahí Collado, University of Colorado, Boulder
SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are:
- Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns?
- Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being?
This is a single-arm pilot study without comparison group.
Participants will:
- Participate in the 6-8 week SanaMente peer-led group program.
- Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction.
- Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.
Обзор исследования
Статус
Статус
Рекрутинг
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
This Stage IB feasibility and pilot study is designed to refine and evaluate the SanaMente program, a culturally tailored, peer-led intervention developed to address the intersecting mental and physical health needs of rural Latinx adults living with chronic medical conditions. The study will assess implementation processes and generate preliminary evidence to inform a future, fully powered efficacy trial.
The intervention will be delivered by bilingual peer mentors who will receive standardized training prior to facilitating small group sessions. Throughout the study, implementation outcomes-including recruitment, retention, attendance, intervention fidelity, and participant engagement-will be monitored to evaluate the practicality of delivering the program in rural community settings.
A mixed-methods evaluation will be used to examine both implementation and participant outcomes. Quantitative analyses will estimate changes in mental health symptoms, health behaviors, and overall well-being over the course of the intervention, with effect size estimates used to inform the design and sample size of future studies. Qualitative data collected from participant feedback will be analyzed to identify factors influencing program engagement, perceived benefits, barriers to participation, and recommendations for improving program content and delivery.
Study findings will be used to optimize the SanaMente intervention, enhance its cultural relevance and implementation strategies, and establish the feasibility of conducting a larger randomized controlled trial to evaluate its effectiveness.
Тип исследования
Тип исследования
Интервенционный
Регистрация (Оцененный)
Регистрация
40
Фаза
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
Контакты исследования
- Имя: Antonella Onofrietti Magrassi, PhD
- Номер телефона: 15417807253
- Электронная почта: antonella.onofrietti@colorado.edu
Учебное резервное копирование контактов
- Имя: Anahi Collado, PhD
- Номер телефона: 3052835243
- Электронная почта: anahi.collado@colorado.edu
Места учебы
-
-
Colorado
-
Carbondale, Colorado, Соединенные Штаты, 81623
- Рекрутинг
- La Clinica del Pueblo
-
Контакт:
- Jenny Lang, Clinical Director, FNP
- Номер телефона: 9706183841
- Электронная почта: jenny@peoplesclinic.care
-
-
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
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- Adults aged 18 years or older.
- Identify as Hispanic/Latino/a.
- Patients of La Clínica del Pueblo in Carbondale, Colorado.
- Spanish-speaking (bilingual Spanish-English speakers are eligible).
- Interest in improving your physical and emotional well-being.
- Are currently managing or are at risk for chronic medical or metabolic conditions (e.g., diabetes, cardiovascular disease, liver, or kidney conditions), but a diagnosis is not required.
- Experiencing or at risk for stress, low mood, or anxiety (formal diagnosis not required)
- Willingness and ability to participate in the SanaMente program.
- Willing to provide a release of information authorizing study staff to communicate with La Clínica del Pueblo in the event that a participant endorses suicidality or if it becomes necessary to share relevant medical information to ensure participant safety and appropriate care.
Exclusion Criteria:
- Individuals who are unable to provide informed consent.
- Individuals who are unwilling or unable to participate in the group-based or one-to-one SanaMente sessions.
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: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Количество рук
1
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
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Экспериментальный: SanaMente Program
This is a single-arm, open-label study in which all participants receive the SanaMente intervention.
Participants will be enrolled into peer-led groups of approximately 6-10 individuals and will complete the 6-8 week program.
|
SanaMente is a culturally responsive, peer-led behavioral program designed to support mental health and promote healthy lifestyle behaviors among rural Latino/a adults with chronic medical conditions and mental health concerns.
The program is delivered by trained bilingual peer mentors in small group sessions over 6-8 weeks and integrates evidence-based strategies to improve depression, anxiety, stress, sleep, physical activity, nutrition, and overall well-being.
The intervention emphasizes culturally relevant content, peer support, and skill-building to enhance self-management and emotional wellness.
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Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item self-report measure of depressive symptom severity.
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Change in total score from baseline to post-program will be evaluated.
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Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
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Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 is a 7-item self-report measure of anxiety symptom severity.
Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Change in total score from baseline to post-program will be evaluated.
|
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
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Body Weight
Временное ограничение: Baseline and Post-Program (week6-8)
|
Body weight will be measured in kilograms (kg) using a calibrated digital scale following standardized clinical procedures.
Change in body weight from baseline to post-program will be evaluated.
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Baseline and Post-Program (week6-8)
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Systolic Blood Pressure
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.
Change from baseline to post-program will be evaluated.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
|
Diastolic Blood Pressure
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
|
Resting Heart Rate
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
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Glycemic control as assessed by Hemoglobin A1c (HbA1c)
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
HbA1c will be measured from a blood sample as an indicator of average blood glucose over the previous 2-3 months.
Values are reported as percentage (%).
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
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Total Cholesterol
Временное ограничение: Changes from baseline to post-program (week 6-8) will be evaluated.
|
Fasting total cholesterol will be measured in mg/dL.
|
Changes from baseline to post-program (week 6-8) will be evaluated.
|
|
LDL Cholesterol
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
|
HDL Cholesterol
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
|
Triglycerides
Временное ограничение: Changes from Baseline and Post-Program (week6-8) will be evaluated
|
Fasting triglycerides will be measured in mg/dL.
|
Changes from Baseline and Post-Program (week6-8) will be evaluated
|
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Alanine aminotransferase (ALT)
Временное ограничение: Changes from baseline to post-program (week 6-8) will be evaluated.
|
Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U/L.
ALT is a marker of hepatocellular injury.
|
Changes from baseline to post-program (week 6-8) will be evaluated.
|
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Electrolytes
Временное ограничение: Changes from baseline to post-program (week 6-8) will be evaluated.
|
Electrolyte balance will be assessed using serum sodium (mEq/L), potassium (mEq/L), and chloride (mEq/L), obtained from fasting blood samples.
These measures reflect systemic fluid and electrolyte homeostasis.
|
Changes from baseline to post-program (week 6-8) will be evaluated.
|
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Metabolic Function
Временное ограничение: Changes from baseline to post-program (week 6-8) will be evaluated.
|
Metabolic function will be assessed using fasting plasma glucose (mg/dL), obtained from fasting blood samples as an indicator of glycemic status..
|
Changes from baseline to post-program (week 6-8) will be evaluated.
|
|
Aspartate aminotransferase (AST)
Временное ограничение: Changes from Baseline to Post-program (week 6-8) will be evaluated
|
Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U/L.
AST is a marker of hepatocellular injury.
|
Changes from Baseline to Post-program (week 6-8) will be evaluated
|
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Total bilirubin
Временное ограничение: Changes from Baseline to post-program (week 6-8) will be evaluated
|
Total bilirubin will be assessed in fasting blood samples and reported in mg/dL.
Total bilirubin is a marker of hepatic excretory function.
|
Changes from Baseline to post-program (week 6-8) will be evaluated
|
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Serum albumin
Временное ограничение: Changes from Baseline to post-program (week 6-8) will be evaluated
|
Serum albumin will be assessed in fasting blood samples and reported in g/dL.
Serum albumin is a marker of hepatic synthetic function and nutritional status.
|
Changes from Baseline to post-program (week 6-8) will be evaluated
|
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Serum creatinine
Временное ограничение: Changes from Baseline to post-program (week 6-8) will be evaluated
|
Serum creatinine will be assessed in fasting blood samples and reported in mg/dL.
Serum creatinine is a marker of glomerular filtration and renal function.
|
Changes from Baseline to post-program (week 6-8) will be evaluated
|
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Blood urea nitrogen (BUN)
Временное ограничение: Changes from Baseline to post-program (weeks 6-8) will be evaluated
|
Blood urea nitrogen (BUN) will be assessed in fasting blood samples and reported in mg/dL.
BUN is a marker of renal function and protein metabolism.
|
Changes from Baseline to post-program (weeks 6-8) will be evaluated
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
Perceived Stress Scale-10 (PSS-10).
The PSS-10 is a 10-item self-report measure that assesses the degree to which situations in one's life are appraised as stressful during the past month.
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Change in total PSS-10 score from baseline to post-program will be evaluated.
|
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
|
Behavioral activation as assessed by the Behavioral Activation for Depression Scale-Short Form (BADS-SF)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
Behavioral Activation for Depression Scale-Short Form (BADS-SF).
The BADS-SF is a self-report measure of behavioral activation and avoidance associated with depression.
Total scores range from 0 to 54, with higher scores indicating greater behavioral activation.
Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
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Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
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Disability and functioning as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; 12-item, self-administered version).
The WHODAS 2.0 is a 12-item self-report measure assessing disability and functioning across six domains of daily life.
Total scores range from 0 to 48 using simple scoring, with higher scores indicating greater disability.
Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
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Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
|
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
Временное ограничение: Baseline, mid program (week 3-4), post-program (week 6-8)
|
International Physical Activity Questionnaire (IPAQ; Short Form).
The IPAQ is a validated self-report instrument designed to assess health-related physical activity across countries.
The short form includes 4 items assessing frequency and duration of vigorous activity, moderate activity, walking, and sitting during the last 7 days.
Physical activity will be summarized as total metabolic equivalent (MET)-minutes per week.
Higher values indicate greater physical activity.
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Baseline, mid program (week 3-4), post-program (week 6-8)
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Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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Dietary Screener Questionnaire (DSQ).
The DSQ is a self-report instrument developed to assess dietary intake patterns over the past 30 days, including frequency of consumption of fruits, vegetables, fiber, whole grains, dairy, added sugars, and other dietary components.
The DSQ is used to estimate intake of specific food groups rather than generate a single total score.
Higher estimated values indicate greater consumption of the respective dietary components being assessed.
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Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
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Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)
Временное ограничение: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
|
Everyday Discrimination Scale (EDS).
The EDS is a self-report measure assessing the frequency of routine experiences of unfair treatment and discrimination in daily life.
The standard scale includes multiple items rated on a Likert-type frequency scale, with response options typically ranging from "never" to "almost every day."
Total scores are calculated by summing item responses, with higher scores indicating greater perceived discrimination.
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Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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Другие показатели результатов
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Временное ограничение: Post-program (weeks 6-8)
|
Participant satisfaction with the SanaMente program will be assessed using the Client Satisfaction Questionnaire (CSQ-8).
Higher scores indicate greater satisfaction with the program and services received.
|
Post-program (weeks 6-8)
|
|
Program usability and acceptability
Временное ограничение: Post-program (week 6-8)
|
Participants will complete an investigator-developed exit survey assessing the program's usability, cultural relevance, perceived impact, and recommendations for improvement.
|
Post-program (week 6-8)
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Participant demographic Characteristics
Временное ограничение: baseline
|
Demographic information, including age, sex, gender identity, education, country of origin, language preference, employment status, and other background characteristics, will be collected to describe the study population and explore associations with study outcomes.
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baseline
|
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Suicide risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Screener
Временное ограничение: As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
|
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Screener to identify suicidal ideation and behaviors and facilitate appropriate safety referrals when indicated.
This is a safety assessment and not an efficacy outcome.
|
As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
|
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Alcohol Use Disorders Identification Test (AUDIT)
Временное ограничение: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
|
Alcohol use will be assessed among participants who endorse current alcohol use using the Alcohol Use Disorders Identification Test (AUDIT).
The AUDIT is a validated 10-item self-report questionnaire that assesses hazardous and harmful alcohol consumption and alcohol-related problems.
|
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
|
|
Drug Use Disorders Identification Test (DUDIT)
Временное ограничение: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
|
Drug use will be assessed among participants who endorse current drug use using the Drug Use Disorders Identification Test (DUDIT).
The DUDIT is a validated self-report questionnaire that assesses the frequency and severity of drug use and drug-related problems.
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Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
|
|
Fagerström Test for Nicotine Dependence (FTND)
Временное ограничение: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
|
Nicotine dependence will be assessed among participants who endorse current tobacco or nicotine use using the Fagerström Test for Nicotine Dependence (FTND).
The FTND is a validated self-report questionnaire that assesses the severity of nicotine dependence.
|
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Главный следователь: Anahi Collado, PhD, University of Colorado, Boulder
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
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)
Начало исследования
6 марта 2026 г.
Первичное завершение (Оцененный)
Первичное завершение
30 сентября 2026 г.
Завершение исследования (Оцененный)
Завершение исследования
10 декабря 2026 г.
Даты регистрации исследования
Первый отправленный
Первый отправленный
29 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
10 июля 2026 г.
Первый опубликованный (Действительный)
Первый опубликованный
15 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
15 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
10 июля 2026 г.
Последняя проверка
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 25-0557
- 2025*1053 (Другой номер гранта/финансирования: Colorado Department of Public Health and Environment Health Disparities and Community Grant Program)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
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. .