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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54GM104940-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| LA CaTS Clinical Research Resources Core | UNKNOWN |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The specific aims of this research study are to
All eligible participants will be enrolled into the study at the Tulane cardiology clinic for an 8-week period. Key study personnel will screen patients from the clinic interested in the study during their appointment visit. Identifying information that will be collected from participants will be name, date of birth, and telephone number to send them text messages. Potential participants making study inquiries by email will receive prompt responses. If the participant does not enroll in the study because they are not eligible, the information will be shredded. Study personnel will also review medical records of Dr. Keith Ferdinand to identify potential patients and provide the subjects with study information (e.g. flyers, advertisements, recruitment script, etc.) The subjects may then approach the study team about participation. Study personnel will arrange a time and date with the church community site to distribute flyers describing the study to church congregants to seek study interest. Interested persons can be screened on-site for eligibility or at a date to be determined by congregants. Study personnel will use an eligibility checklist to screen participants.
Below are procedures performed during the study and the time expected to complete each task:
This study will follow an 8-week interventional cohort design using a series of questionnaires to collect data pre-post study procedures from two sites: Tulane cardiology clinic and Christian Unity Baptist Church. Participants will be screened for eligibility at both sites by in-person interviews, telephone using an Institutional Review Board (IRB) approved recruitment script, and/or clinic medical records. After screening, eligible participants will be enrolled into the study at Tulane cardiology clinic by study personnel. Blood pressure and weight will be measured by study personnel on the first and the last day of the study, in addition to calculating their risk for heart attack and stroke using the Atherosclerotic cardiovascular disease (ASCVD) Risk Estimator Plus.
9 Study personnel will calculate participant's ASCVD risk by downloading the app on their mobile device. No patient information is collected and stored in the app. Anonymous user behavior (e.g., number of people who downloaded the app, how many times a day the app was used) will be gathered through Google Analytics. All data collected in the app is anonymous and cannot be traced back to an individual user.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Other | Participants will be enrolled in a bidirectional text messaging system from Tulane University Medical Group where they will receive and send text from their mobile phones to monitor their anti-hypertension medication regimen. Text messages will be sent: daily for medication and refill reminders; weekly for hypertension education messages and asking if a support person helped them with medication reminders. Study personnel will educate participants on proper blood pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. Participants will receive the Bluetooth blood pressure device to perform SMBP at enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text | Behavioral | These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner | The change of quality of life will be measured by the responses from the 14-item Center for Disease Control (CDC) Health Related Quality of Life questioner at the enrollment (baseline) visit and at the end of study visit at 2 months. The questioner is a CDC designed quality of life survey that has 14 questions, and the investigators calculated the unhealthy days score for each participant. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. To obtain that estimate, responses to questions 2 and 3 were combined to calculate a summary index of overall unhealthy days with a logical maximum of 30 unhealthy days. The range is from 0 to 30, minimum would be 0 which indicates better outcome and 30 is the maximum and would indicate poor outcome. | Baseline, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure Done by Investigators | Change in systolic and diastolic blood pressure, which was done using 2 seated blood pressure readings using validated approaches, measured in millimeters of mercury from day one of enrollment (baseline) and at end of study visit. | Baseline, 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Ferdinand, MD | Tulane University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Unity Baptist Church | New Orleans | Louisiana | 70112 | United States | ||
| Tulane University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28126162 | Background | Ferdinand KC, Senatore FF, Clayton-Jeter H, Cryer DR, Lewin JC, Nasser SA, Fiuzat M, Califf RM. Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications. J Am Coll Cardiol. 2017 Jan 31;69(4):437-451. doi: 10.1016/j.jacc.2016.11.034. | |
| 31863786 | Background | Ferdinand DP, Nedunchezhian S, Ferdinand KC. Hypertension in African Americans: Advances in community outreach and public health approaches. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):40-45. doi: 10.1016/j.pcad.2019.12.005. Epub 2019 Dec 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Group | Participants will be enrolled in a bidirectional text messaging system from Tulane University Medical Group where they will receive and send text from their mobile phones to monitor their anti-hypertension medication regimen. Text messages will be sent: daily for medication and refill reminders; weekly for hypertension education messages and asking if a support person helped them with medication reminders. Study personnel will educate participants on proper blood pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. Participants will receive the Bluetooth blood pressure device to perform SMBP at enrollment. Text: These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Group | Participants will be enrolled in a bidirectional text messaging system from Tulane University Medical Group where they will receive and send text from their mobile phones to monitor their anti-hypertension medication regimen. Text messages will be sent: daily for medication and refill reminders; weekly for hypertension education messages and asking if a support person helped them with medication reminders. Study personnel will educate participants on proper blood pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. Participants will receive the Bluetooth blood pressure device to perform SMBP at enrollment. Text: These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner | The change of quality of life will be measured by the responses from the 14-item Center for Disease Control (CDC) Health Related Quality of Life questioner at the enrollment (baseline) visit and at the end of study visit at 2 months. The questioner is a CDC designed quality of life survey that has 14 questions, and the investigators calculated the unhealthy days score for each participant. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. To obtain that estimate, responses to questions 2 and 3 were combined to calculate a summary index of overall unhealthy days with a logical maximum of 30 unhealthy days. The range is from 0 to 30, minimum would be 0 which indicates better outcome and 30 is the maximum and would indicate poor outcome. | Posted | Mean | Standard Deviation | Days | Baseline, 2 months |
|
2 months
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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 | Patient Group | Participants will be enrolled in a bidirectional text messaging system from Tulane University Medical Group where they will receive and send text from their mobile phones to monitor their anti-hypertension medication regimen. Text messages will be sent: daily for medication and refill reminders; weekly for hypertension education messages and asking if a support person helped them with medication reminders. Study personnel will educate participants on proper blood pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. Participants will receive the Bluetooth blood pressure device to perform SMBP at enrollment. Text: These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Ferdinand | Tulane University School of Medicine | 504-988-5492 | kferdina@tulane.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 16, 2021 | Jul 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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| Self-report Adherence to Medication |
Self-report adherence to medication will be measured based on qualitative analysis of the Krousel-Wood Medication Adherence Scale 4. The subject will complete the survey twice, at baseline visit and at the end of study visit. The score range is 0 to 4 with a higher score indicating worse adherence, and a lower score indicating better adherence. |
| Baseline, 2 months |
| Change in Systolic and Diastolic Blood Pressure Done by the Participant | The subjects were asked to perform the self measured systolic and diastolic blood pressure readings at home everyday. There is increased accuracy of obtaining 7-day average systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements to assess blood pressure lowering, these measurements were obtained during the first and last week of the study. The investigators used the first and last 7-day average to calculate this outcome measure. | First week of the study, Last week of the study |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type 2 Diabetes | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
| Patient Group |
Participants will be enrolled in a bidirectional text messaging system from Tulane University Medical Group where they will receive and send text from their mobile phones to monitor their anti-hypertension medication regimen. Text messages will be sent: daily for medication and refill reminders; weekly for hypertension education messages and asking if a support person helped them with medication reminders. Study personnel will educate participants on proper blood pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. Participants will receive the Bluetooth blood pressure device to perform SMBP at enrollment. Text: These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure. |
|
|
| Secondary | Change in Systolic and Diastolic Blood Pressure Done by Investigators | Change in systolic and diastolic blood pressure, which was done using 2 seated blood pressure readings using validated approaches, measured in millimeters of mercury from day one of enrollment (baseline) and at end of study visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, 2 months |
|
|
|
| Secondary | Self-report Adherence to Medication | Self-report adherence to medication will be measured based on qualitative analysis of the Krousel-Wood Medication Adherence Scale 4. The subject will complete the survey twice, at baseline visit and at the end of study visit. The score range is 0 to 4 with a higher score indicating worse adherence, and a lower score indicating better adherence. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 months |
|
|
|
| Secondary | Change in Systolic and Diastolic Blood Pressure Done by the Participant | The subjects were asked to perform the self measured systolic and diastolic blood pressure readings at home everyday. There is increased accuracy of obtaining 7-day average systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements to assess blood pressure lowering, these measurements were obtained during the first and last week of the study. The investigators used the first and last 7-day average to calculate this outcome measure. | Posted | Mean | Standard Deviation | mmHg | First week of the study, Last week of the study |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
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| Diastolic blood pressure at 2 months |
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| Diastolic blood pressure (last 7-day average) |
|