Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02664610
• Collaborator: (none)
• Enrollment: 94
• Arms: 2
• Actual Duration (Months): 14.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Stroke	Behavioral: Text Messaging	N/A

Detailed Description

This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: REACH OUT: to Reduce High Blood Pressure
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No text messages, hypertensive Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
Experimental: Text messages, hypertensive Participants who have high blood pressure, who are randomized to receive text messages.	Behavioral: Text Messaging; hypertensive participants will be randomized to receive tailored, motivational text messages

Outcome Measures

Primary Outcome Measures

1. Mean Change in Systolic Blood Pressure [Baseline to 6 months]

Secondary Outcome Measures

1. Mean Change in Diastolic Blood Pressure [Baseline to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Lesli Skolarus, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lesli E. Skolarus, MD, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02664610
• Other Study ID Numbers: GO13884
• First Posted: Jan 27, 2016
• Last Update Posted: Jul 17, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lesli E. Skolarus, MD, Assistant Professor, University of Michigan: hypertension treatment; stroke prevention
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	No Text Messages, Hypertensive	Text Messages, Hypertensive
Arm/Group Description	Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Period Title: Overall Study
STARTED	46	48
COMPLETED	32	41
NOT COMPLETED	14	7

Baseline Characteristics

Arm/Group Title	No Text Messages, Hypertensive	Text Messages, Hypertensive	Total
Arm/Group Description	Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages	Total of all reporting groups
Overall Participants	46	48	94
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (9.8)	58 (8.5)	58 (9.8)
Sex: Female, Male (Count of Participants)
Female	36 78.3%	38 79.2%	74 78.7%
Male	10 21.7%	10 20.8%	20 21.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	45 97.8%	47 97.9%	92 97.9%
White	1 2.2%	1 2.1%	2 2.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	46 100%	48 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Systolic Blood Pressure
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Text Messages, Hypertensive	Text Messages, Hypertensive
Arm/Group Description	Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Measure Participants	32	41
Change from baseline	-14.4 (26.4)	-11.3 (22.9)
Baseline	162.2 (20.5)	160.7 (23.6)
6 months	146.7 (20.5)	147.2 (21.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Text Messages, Hypertensive, Text Messages, Hypertensive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Mean Change in Diastolic Blood Pressure
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Text Messages, Hypertensive	Text Messages, Hypertensive
Arm/Group Description	Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Measure Participants	32	41
Change from baseline	-9.5 (12.9)	-8.6 (15.9)
Baseline	99.2 (17.8)	99.0 (11.8)
6 months	88.5 (11.5)	89.4 (13.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Text Messages, Hypertensive, Text Messages, Hypertensive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	No Text Messages, Hypertensive		Text Messages, Hypertensive
Arm/Group Description	Participants who have high blood pressure, who are randomized to health information (do not receive text messages).		Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
All Cause Mortality
	No Text Messages, Hypertensive		Text Messages, Hypertensive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	No Text Messages, Hypertensive		Text Messages, Hypertensive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	No Text Messages, Hypertensive		Text Messages, Hypertensive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.