NCT05074173

Text My Hypertension BP Meds NOLA

Completed NA Results posted Last updated 21 August 2023

What this trial tests

NA trial testing Text in Hypertension in 36 participants. Completed in 28 May 2022.

Timeline

10 March 2022

Primary endpoint
28 May 2022

28 May 2022

Quick facts

Lead sponsor	Tulane University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	36
Start date	10 March 2022
Primary completion	28 May 2022
Estimated completion	28 May 2022
Sites	2 locations across United States

Drugs / interventions tested

• Text

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Tulane University

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner Primary · Baseline, 2 months

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, resp

Baseline

Group	Value	95% CI
Patient Group	9.11	± 10.36

2 Months

Group	Value	95% CI
Patient Group	6.81	± 9.89

Change in Systolic and Diastolic Blood Pressure Done by Investigators Secondary · Baseline, 2 months

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.

Systolic blood pressure at baseline

Group	Value	95% CI
Patient Group	142.19	± 18.94

Systolic blood pressure at 2 months

Group	Value	95% CI
Patient Group	131.69	± 13.99

Diastolic blood pressure at baseline

Group	Value	95% CI
Patient Group	81.19	± 11.17

Diastolic blood pressure at 2 months

Group	Value	95% CI
Patient Group	79.49	± 9.36

Self-report Adherence to Medication Secondary · Baseline, 2 months

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.

Adherence at baseline

Group	Value	95% CI
Patient Group	2.19	± 0.86

Adherence at 2 months

Group	Value	95% CI
Patient Group	1.58	± 0.87

Change in Systolic and Diastolic Blood Pressure Done by the Participant Secondary · First week of the study, Last week of the study

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.

Systolic blood pressure (first 7-day average)

Group	Value	95% CI
Patient Group	131.21	± 12.34

Systolic blood pressure (last 7-day average)

Group	Value	95% CI
Patient Group	127.00	± 11.54

Diastolic blood pressure (first 7-day average)

Group	Value	95% CI
Patient Group	78.07	± 6.45

Diastolic blood pressure (last 7-day average)

Group	Value	95% CI
Patient Group	77.00	± 8.77

Sponsor's own description

The specific aims of this research study are to

1. Engage participants with poorly controlled hypertension and medication non-adherence to use simple digital approaches, specifically recurring text-messages to improve medication adherence.
2. Promote participant medication adherence and interaction with telehealth platforms with recurring text reminders on medication schedules and refills, science-based hypertension education content, and communication exchange with their health providers to improve blood pressure.
3. Evaluate the role of social support in helping participants manage their hypertension and control of Cardiovascular disease (CVD) risk factors, including daily blood pressure measurement, changes in participant quality of life, and barriers towards medication adherence, and setting goals for health behaviors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. TEXT MY BP MEDS NOLA: A pilot study of text-messaging and social support to increase hypertension medication adherence.
   Ferdinand DP, Reddy TK, Wegener MR, Guduri PS, et al · · 2023 · cited 13× · PMID 37712088 · DOI 10.1016/j.ahjo.2023.100253