NCT02664610

Brief Summary

One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition. Hypertension is significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor. This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2017

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

October 6, 2015

Results QC Date

December 15, 2016

Last Update Submit

May 8, 2023

Conditions

Keywords

hypertension treatmentstroke prevention

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Systolic Blood Pressure

    Baseline to 6 months

Secondary Outcomes (1)

  • Mean Change in Diastolic Blood Pressure

    Baseline to 6 months

Study Arms (2)

No text messages, hypertensive

NO INTERVENTION

Participants who have high blood pressure, who are randomized to health information (do not receive text messages).

Text messages, hypertensive

EXPERIMENTAL

Participants who have high blood pressure, who are randomized to receive text messages.

Behavioral: Text Messaging

Interventions

Text MessagingBEHAVIORAL

hypertensive participants will be randomized to receive tailored, motivational text messages

Text messages, hypertensive

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.

You may not qualify if:

  • Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionStroke

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

high lost to follow up rate. Unknown why participants did not complete the study

Results Point of Contact

Title
Lesli Skolarus
Organization
University of Michigan

Study Officials

  • Lesli Skolarus

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2015

First Posted

January 27, 2016

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

June 5, 2023

Results First Posted

July 17, 2017

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share