Informational Support for Anemia

(MARCH Trial)

Not yet recruiting at 1 trial location
KT
AR
Overseen ByArthi Ramakrishnan, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

EM

Erica Marsh, MD, MSCI

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for Black/African American and/or Hispanic or Latino women who have anemia, including those with iron deficiency or abnormal uterine/vaginal bleeding. Participants should be adults able to take part in community health programs.

Inclusion Criteria

Has had a menstrual period in the last 6 months
Self-identify as black/African American and/or Hispanic/Latino
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
See 1 more

Exclusion Criteria

Hgb by POC test is less than 7.0 g/dL
I am currently pregnant.
I have had bariatric surgery for weight loss.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Community Health Worker Led Psychosocial Intervention

Trial Overview

The study compares standard medical care for anemia with an added program led by community health workers that provides education and follow-up support. The goal is to see if this extra help improves blood hemoglobin levels more than usual care alone.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2-SOC and Education/CHW inputExperimental Treatment2 Interventions
Group II: Group 1-Standard of Care (SOC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+