Trial Outcomes & Findings for Text My Hypertension BP Meds NOLA (NCT NCT05074173)
NCT ID: NCT05074173
Last Updated: 2023-08-21
Results Overview
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.
COMPLETED
NA
36 participants
Baseline, 2 months
2023-08-21
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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36
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Overall Study
COMPLETED
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36
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Text My Hypertension BP Meds NOLA
Baseline characteristics by cohort
| Measure |
Patient Group
n=36 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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34 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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2 Participants
n=99 Participants
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Age, Continuous
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58.68 Years
STANDARD_DEVIATION 12.78 • n=99 Participants
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Sex: Female, Male
Female
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23 Participants
n=99 Participants
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Sex: Female, Male
Male
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13 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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32 Participants
n=99 Participants
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Race (NIH/OMB)
White
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4 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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36 participants
n=99 Participants
|
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Type 2 Diabetes
Yes
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26 Participants
n=99 Participants
|
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Type 2 Diabetes
No
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9 Participants
n=99 Participants
|
|
Type 2 Diabetes
Unknown
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1 Participants
n=99 Participants
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Obesity
Obese
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26 Participants
n=99 Participants
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Obesity
Not Obese
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10 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline, 2 monthsThe 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.
Outcome measures
| Measure |
Patient Group
n=36 Participants
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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|---|---|
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Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner
Baseline
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9.11 Days
Standard Deviation 10.36
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Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner
2 Months
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6.81 Days
Standard Deviation 9.89
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SECONDARY outcome
Timeframe: Baseline, 2 monthsChange 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.
Outcome measures
| Measure |
Patient Group
n=36 Participants
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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Change in Systolic and Diastolic Blood Pressure Done by Investigators
Systolic blood pressure at baseline
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142.19 mmHg
Standard Deviation 18.94
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Change in Systolic and Diastolic Blood Pressure Done by Investigators
Systolic blood pressure at 2 months
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131.69 mmHg
Standard Deviation 13.99
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Change in Systolic and Diastolic Blood Pressure Done by Investigators
Diastolic blood pressure at baseline
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81.19 mmHg
Standard Deviation 11.17
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Change in Systolic and Diastolic Blood Pressure Done by Investigators
Diastolic blood pressure at 2 months
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79.49 mmHg
Standard Deviation 9.36
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SECONDARY outcome
Timeframe: Baseline, 2 monthsSelf-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.
Outcome measures
| Measure |
Patient Group
n=36 Participants
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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|---|---|
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Self-report Adherence to Medication
Adherence at baseline
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2.19 units on a scale
Standard Deviation 0.86
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Self-report Adherence to Medication
Adherence at 2 months
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1.58 units on a scale
Standard Deviation 0.87
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SECONDARY outcome
Timeframe: First week of the study, Last week of the studyThe 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.
Outcome measures
| Measure |
Patient Group
n=36 Participants
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.
|
|---|---|
|
Change in Systolic and Diastolic Blood Pressure Done by the Participant
Systolic blood pressure (first 7-day average)
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131.21 mmHg
Standard Deviation 12.34
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Change in Systolic and Diastolic Blood Pressure Done by the Participant
Systolic blood pressure (last 7-day average)
|
127.00 mmHg
Standard Deviation 11.54
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Change in Systolic and Diastolic Blood Pressure Done by the Participant
Diastolic blood pressure (first 7-day average)
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78.07 mmHg
Standard Deviation 6.45
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Change in Systolic and Diastolic Blood Pressure Done by the Participant
Diastolic blood pressure (last 7-day average)
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77.00 mmHg
Standard Deviation 8.77
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Adverse Events
Patient Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place