Menstruation and Anemia Research: A Community Health Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Hemoglobin levels (group level change)
研究概览
简要总结
This research is studying if a community-based, community health worker (CHW) led psychosocial intervention improves hemoglobin levels among Black/African American and/or Hispanic or Latino women with anemia compared to standard of care.
The intervention group will demonstrate a greater mean increase in hemoglobin at follow up than the control group. The expected treatment difference effect is a between group difference of 1.0-point or greater in mean Hgb at follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identify as black/African American and/or Hispanic/Latino
- •Has had a menstrual period in the last 6 months
- •Hemoglobin (Hgb) by point of care (POC) test is less than 12.0 g/dL and greater than or equal to 7.0 g/dL
- •Able to read, write, and communicate in Spanish and/or English
排除标准
- •Received iron infusion in the past month
- •Recent (within the last 4 weeks) or anticipated major surgery with anesthesia for greater than 30 minutes within the next 3 months
- •Undergone Bariatric (i.e. weight-loss) Surgery including Gastric Bypass Surgery, Gastric Sleeve Surgery or other Bariatric Surgery
- •Diagnosed with anemia related to a condition other than iron deficiency, such as thalassemia or sickle cell disease or are a carrier.
- •Diagnosed with cancer (not including thyroid, cervical, or non-melanoma skin cancer)
- •Currently or within the last 3 months experiencing bloody or black tarry stools
- •Currently or within the last 3 months vomiting blood or emesis that resembles dark coffee grounds
- •Currently pregnant women
- •Hgb by POC test is less than 7.0 g/dL
研究组 & 干预措施
Group 1-Standard of Care (SOC)
Participants will be notified that they are anemic and receive written/verbal information on anemia and instructed to follow up with their healthcare provider (standard care)
干预措施: Standard of Care (Behavioral)
Group 2-SOC and Education/CHW input
Standard care and attend a community-based series of group-based information sessions and receive support from CHW to follow up with healthcare providers about their anemia
干预措施: Standard of Care (Behavioral)
Group 2-SOC and Education/CHW input
Standard care and attend a community-based series of group-based information sessions and receive support from CHW to follow up with healthcare providers about their anemia
干预措施: Informational Series and follow-up support (Behavioral)
结局指标
主要结局
Hemoglobin levels (group level change)
时间窗: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Blood samples will be obtained to measure hemoglobin levels
次要结局
- Hemoglobin (Hgb) values (individual change)(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
- Self-reported hemoglobin levels(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
- Anemia status awareness(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
- Knowledge of anemia(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
- Confidence in managing anemia as measured by the Perceived Competence Scale(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
- Knowledge of Abnormal uterine bleeding (AUB)/menstrual health based on knowledge assessment(Visit 1 (approximately day 1), Visit 7 (approximately day 112))
研究者
Erica Marsh
Professor of Reproductive Medicine and Obstetrics and Gynecology
University of Michigan