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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1TR004403-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Pharmacist Monitoring | Experimental | The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research Pharmacist | Behavioral | The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Talk to Research Pharmacist | We will calculate the number of participants who talk to the research pharmacist during the course of the intervention. | Through study completion, an average of 30 days |
| Number of Participants Who Return BP Measurements | We will calculate the number of participants who return at least one blood pressure measurement via text message. | Through study completion, an average of 30 days |
| Percentage of Well-Child Visits Attended | We will calculate the percentage of well-child visits that are attended by each family. | Through study completion, an average of 30 days |
| Percentage of Vaccinations Received | We will calculate the percentage of vaccinations received by each child. | Through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of BP Measurements Submitted | We will calculate the number of blood pressure values that are submitted by each participant. | Through study completion, an average of 30 days |
| Blood Pressure Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Tran, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Research Pharmacist Monitoring | The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. Research Pharmacist: The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Research Pharmacist Monitoring | The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. Research Pharmacist: The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Talk to Research Pharmacist | We will calculate the number of participants who talk to the research pharmacist during the course of the intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 30 days |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Research Pharmacist Monitoring | The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. Research Pharmacist: The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linnea Polgreen | University of Iowa | (319) 384-3024 | linnea-polgreen@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2023 | Jul 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2025 | Jul 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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We will determine how many participants' blood pressure is controlled after the intervention.
| Through study completion, an average of 30 days |
| Number of Participants Satisfied With the Study | We will measure participant satisfaction with the study using an exit survey. Satisfaction will be measured by a response of Extremely Helpful or Helpful on the question- My contact(s) with the pharmacist about my health were.... | Through study completion, an average of 30 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Primary | Number of Participants Who Return BP Measurements | We will calculate the number of participants who return at least one blood pressure measurement via text message. | Posted | Count of Participants | Participants | Through study completion, an average of 30 days |
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| Primary | Percentage of Well-Child Visits Attended | We will calculate the percentage of well-child visits that are attended by each family. | Posted | Count of Units | Well-child visits | Through study completion, an average of 30 days | Well-child visits | Well-child visits |
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| Primary | Percentage of Vaccinations Received | We will calculate the percentage of vaccinations received by each child. | Posted | Count of Units | Vaccinations | Through study completion, an average of 30 days | Vaccinations | Vaccinations |
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| Secondary | Number of BP Measurements Submitted | We will calculate the number of blood pressure values that are submitted by each participant. | Posted | Mean | Standard Deviation | Mean Number of Blood Pressure Values | Through study completion, an average of 30 days |
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| Secondary | Blood Pressure Control | We will determine how many participants' blood pressure is controlled after the intervention. | Only 13 participants provided information on blood pressure control at the end of the study, but they did not withdraw from the study. | Posted | Count of Participants | Participants | Through study completion, an average of 30 days |
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| Secondary | Number of Participants Satisfied With the Study | We will measure participant satisfaction with the study using an exit survey. Satisfaction will be measured by a response of Extremely Helpful or Helpful on the question- My contact(s) with the pharmacist about my health were.... | Posted | Count of Participants | Participants | Through study completion, an average of 30 days |
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| 0 |
| 25 |
| 0 |
| 25 |
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| 25 |
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