NCT05074173

Brief Summary

The specific aims of this research study are to

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

September 29, 2021

Results QC Date

July 24, 2023

Last Update Submit

August 17, 2023

Conditions

Hypertension

Keywords

Quality of lifeAdherenceHigh blood pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Systolic and Diastolic Blood Pressure Done by Investigators

    Baseline, 2 months

  • Self-report Adherence to Medication

    Baseline, 2 months

  • Change in Systolic and Diastolic Blood Pressure Done by the Participant

    First week of the study, Last week of the study

Study Arms (1)

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.

Behavioral: Text

Interventions

TextBEHAVIORAL

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.

Patient Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 years of age.
  • Speak and read English.
  • Diagnosis of stage 1\* and 2\*\* hypertension (HTN), taking at least one antihypertensive medication.
  • Internet and mobile phone access with two-way texting capability.
  • \> 1 on 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) or similar tool.
  • Able to download blood pressure tracking App to mobile phone. (\*Stage 1 HTN: 130-139 mmHg or 80-89 mmHg16) (\*\*Stage 2 HTN: 140 mmHg or higher or \>90 mmHg16)

You may not qualify if:

  • Having been hospitalized within 6 months of starting the study if the patient has a diagnosis of heart failure, end-stage kidney disease, acute coronary syndrome, or stroke.
  • Plans to cancel mobile phone plan within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christian Unity Baptist Church

New Orleans, Louisiana, 70112, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (2)

  • 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.

    PMID: 28126162BACKGROUND

  • 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.

    PMID: 31863786BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Self-Help DevicesEquipment and Supplies

Results Point of Contact

Title
Keith Ferdinand
Organization
Tulane University School of Medicine
kferdina@tulane.edu
504-988-5492

Study Officials

  • Keith Ferdinand, MD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

March 10, 2022

Primary Completion

May 28, 2022

Study Completion

May 28, 2022

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-08

Locations

US(2)