NCT07091032招募中不适用
Building Connections Between Practices, Patients, and Community Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,600
- 试验地点
- 2
- 主要终点
- Self-reported height/weight for Body Mass Index (BMI)
研究概览
简要总结
Building Connections seeks to address health and healthcare inequities in socially vulnerable communities. The project will be conducted in collaboration with clinical practices across Massachusetts, serving a diverse population heavily represented in Community Clinics and Health Centers. The program will offer evidence-based interventions in obesity/weight management, cancer screening, and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The general inclusion criteria involve being 18+, speaking English or Spanish, and meeting one or more of the following criteria:
- •Obesity: Patients with a body mass index of 30 kg/m2 or greater (i.e., obese category).
- •Cancer screening: Average-risk patients without recommended colorectal or cervical cancer screenings for their age group and biological sex. Specifically:
- •Colon Cancer (CRC) inclusion criteria: Patients aged 45-75 who are due for screenings, with last FIT longer than 1 year ago, last colonoscopy longer than 10 years ago, and last Cologuard longer than 3 years ago.
- •Cervical cancer inclusion criteria: Women and patients with a cervix aged 30-65 who are due for screening: with last pap longer than 3 years ago; last co-test longer than 5 years ago; last primary HPV screening longer than 5 years ago.
- •Mental health: Patients with moderate to severe depression or anxiety symptoms.
排除标准
- •The general exclusion criteria are: those with current pregnancy, or the participant is cognitively impaired, not having a visit to the primary care clinic in the prior 2 years, and speaking a language other than English or Spanish.
- •Exclusion criteria for obesity intervention: had prior metabolic or bariatric surgery or planning to have this surgery in the next 6 months, currently enrolled in an intensive lifestyle program.
- •Exclusion criteria for cancer screening intervention include:
- •Colon Cancer (CRC) exclusion criteria: has colorectal cancer documented in the problem list; has ulcerative colitis or Crohn's disease documented in the problem list
- •Cervical cancer exclusion criteria: has cervical cancer documented in the problem list; has had a prior hysterectomy.
- •Exclusion criteria for mental health: include patients with active suicidality, active substance use disorder, a history of schizophrenia or bipolar disorder, or who are already receiving behavioral health care (therapy sessions in the past 3 months or an appointment upcoming in the next month).
结局指标
主要结局
Self-reported height/weight for Body Mass Index (BMI)
时间窗: Baseline, month 6, and month 12
Calculation of Body Mass Index
Computerized Adaptive Testing (CAT) of Mental Health (MH)
时间窗: Baseline, month 6, month 12
CAT-MH Depression/MDD and Anxiety
Rate of cancer screening test completion
时间窗: Baseline, month 6, month 12
Number of eligible people who complete a screening test out of total eligible
次要结局
- World Health Organization Disability Assessment Schedule (WHODAS) 2.0(Baseline, month 6, month 12)
- Rapid Prime Diet Quality Score Screener (rPDQS)(Baseline, month 6, month 12)
- Cancer screening test type(Baseline, month 6, month 12)
研究者
Margarita Alegria, PhD
Chief, Disparities Research Unit
Massachusetts General Hospital
研究点 (2)
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