An interventional study of Text in Hypertension, sponsored by Tulane University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Tulane University · Not applicable, Interventional, and Supportive care
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.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 36 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Tulane University is the lead sponsor of 98 studies on the registry; 30 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: 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.
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.
Time frame: Baseline, 2 months
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.
Time frame: Baseline, 2 months
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.
Time frame: 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.
Time frame: First week of the study, Last week of the study
| Milestone | Patient Group |
|---|---|
| Started | 36 |
| Completed | 36 |
| Not completed | 0 |
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.
| Days | Patient Group |
|---|---|
| Baseline | 9.11 ± 10.36 |
| 2 Months | 6.81 ± 9.89 |
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.
| mmHg | Patient Group |
|---|---|
| Systolic blood pressure at baseline | 142.19 ± 18.94 |
| Systolic blood pressure at 2 months | 131.69 ± 13.99 |
| Diastolic blood pressure at baseline | 81.19 ± 11.17 |
| Diastolic blood pressure at 2 months | 79.49 ± 9.36 |
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.
| units on a scale | Patient Group |
|---|---|
| Adherence at baseline | 2.19 ± 0.86 |
| Adherence at 2 months | 1.58 ± 0.87 |
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.
| mmHg | Patient Group |
|---|---|
| Systolic blood pressure (first 7-day average) | 131.21 ± 12.34 |
| Systolic blood pressure (last 7-day average) | 127.00 ± 11.54 |
| Diastolic blood pressure (first 7-day average) | 78.07 ± 6.45 |
| Diastolic blood pressure (last 7-day average) | 77.00 ± 8.77 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Group | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Categorical(Participants) | Patient Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 2 |
| Age, Continuous(Years) | Patient Group |
|---|---|
| Mean | 58.68 ± 12.78 |
| Sex: Female, Male(Participants) | Patient Group |
|---|---|
| Female | 23 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | Patient Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 32 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Patient Group |
|---|---|
| United States | 36 |
| Type 2 Diabetes(Participants) | Patient Group |
|---|---|
| Yes | 26 |
| No | 9 |
| Unknown | 1 |
| Obesity(Participants) | Patient Group |
|---|---|
| Obese | 26 |
| Not Obese | 10 |
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