Trial Outcomes & Findings for Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems (NCT NCT03422718)

NCT ID: NCT03422718

Last Updated: 2024-06-20

Results Overview

Change in 12-month Systolic Blood Pressure (SBP)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

488 participants

Primary outcome timeframe

12 months

Results posted on

2024-06-20

Participant Flow

This trial was conducted in Flint, Michigan, an urban, low-income, predominately Black community. Participants were recruited from the city's only safety-net ED (i.e., hospitals where over 25% of patients are Medicaid recipients). Enrollment occurred between March 2019 and March 2020.

Participants entered a run-in phase of 3 weeks to determine whether a participant had persistently elevated BP. During this time, participants were prompted to text their BP once per week to the study team. Participants responding at least once and with at least one systolic BP ≥ 140 or a diastolic BP ≥ 90 were randomized.

Participant milestones

Participant milestones
Measure
Arm 1
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
12 Month Interventional Trial Period
STARTED
62
60
63
61
58
61
64
59
12 Month Interventional Trial Period
6 Month Outcome
26
35
30
29
31
32
29
28
12 Month Interventional Trial Period
COMPLETED
25
31
25
22
30
31
24
23
12 Month Interventional Trial Period
NOT COMPLETED
37
29
38
39
28
30
40
36
Optional Six Month Follow-Up Period
STARTED
25
31
25
22
30
31
24
23
Optional Six Month Follow-Up Period
Opted in to Optional Follow Up Phase
17
20
9
8
13
17
10
13
Optional Six Month Follow-Up Period
COMPLETED
1
1
1
2
2
2
5
3
Optional Six Month Follow-Up Period
NOT COMPLETED
24
30
24
20
28
29
19
20

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 1
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
12 Month Interventional Trial Period
Lost to Follow-up
26
16
23
27
21
22
36
25
12 Month Interventional Trial Period
Withdrawal by Subject
11
13
15
12
7
8
4
11
Optional Six Month Follow-Up Period
Chose Not to start 6 month extension
8
11
16
14
17
14
14
10
Optional Six Month Follow-Up Period
Withdrawal by Subject
0
3
0
0
1
2
0
0
Optional Six Month Follow-Up Period
ineligible
8
5
2
2
1
5
2
4
Optional Six Month Follow-Up Period
Lost to Follow-up
8
11
6
4
9
8
3
6

Baseline Characteristics

Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1
n=62 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
n=60 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
n=63 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
n=61 Participants
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
n=58 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
n=61 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
n=64 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
n=59 Participants
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Total
n=488 Participants
Total of all reporting groups
Age, Continuous
45.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
47.7 years
STANDARD_DEVIATION 11.8 • n=7 Participants
49 years
STANDARD_DEVIATION 11.4 • n=5 Participants
45.3 years
STANDARD_DEVIATION 11.7 • n=4 Participants
45.5 years
STANDARD_DEVIATION 12.5 • n=21 Participants
46.5 years
STANDARD_DEVIATION 12.2 • n=10 Participants
45.6 years
STANDARD_DEVIATION 12.6 • n=115 Participants
45.3 years
STANDARD_DEVIATION 12.2 • n=24 Participants
45.5 years
STANDARD_DEVIATION 12.4 • n=42 Participants
Sex: Female, Male
Female
37 Participants
n=5 Participants
37 Participants
n=7 Participants
38 Participants
n=5 Participants
37 Participants
n=4 Participants
36 Participants
n=21 Participants
38 Participants
n=10 Participants
39 Participants
n=115 Participants
37 Participants
n=24 Participants
299 Participants
n=42 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
23 Participants
n=7 Participants
25 Participants
n=5 Participants
24 Participants
n=4 Participants
22 Participants
n=21 Participants
23 Participants
n=10 Participants
25 Participants
n=115 Participants
22 Participants
n=24 Participants
189 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=24 Participants
17 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
59 Participants
n=5 Participants
59 Participants
n=7 Participants
60 Participants
n=5 Participants
59 Participants
n=4 Participants
55 Participants
n=21 Participants
59 Participants
n=10 Participants
62 Participants
n=115 Participants
58 Participants
n=24 Participants
471 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
29 Participants
n=5 Participants
29 Participants
n=7 Participants
34 Participants
n=5 Participants
31 Participants
n=4 Participants
35 Participants
n=21 Participants
39 Participants
n=10 Participants
35 Participants
n=115 Participants
30 Participants
n=24 Participants
262 Participants
n=42 Participants
Race (NIH/OMB)
White
28 Participants
n=5 Participants
27 Participants
n=7 Participants
27 Participants
n=5 Participants
29 Participants
n=4 Participants
19 Participants
n=21 Participants
19 Participants
n=10 Participants
27 Participants
n=115 Participants
25 Participants
n=24 Participants
201 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=10 Participants
2 Participants
n=115 Participants
4 Participants
n=24 Participants
22 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Region of Enrollment
United States
62 participants
n=5 Participants
60 participants
n=7 Participants
63 participants
n=5 Participants
61 participants
n=4 Participants
58 participants
n=21 Participants
61 participants
n=10 Participants
64 participants
n=115 Participants
59 participants
n=24 Participants
488 participants
n=42 Participants
Prior medication for hypertension within the last 6 months
35 Participants
n=5 Participants
35 Participants
n=7 Participants
34 Participants
n=5 Participants
34 Participants
n=4 Participants
33 Participants
n=21 Participants
33 Participants
n=10 Participants
36 Participants
n=115 Participants
33 Participants
n=24 Participants
273 Participants
n=42 Participants
Currently have a primary care provider
51 Participants
n=5 Participants
50 Participants
n=7 Participants
45 Participants
n=5 Participants
48 Participants
n=4 Participants
47 Participants
n=21 Participants
47 Participants
n=10 Participants
49 Participants
n=115 Participants
43 Participants
n=24 Participants
380 Participants
n=42 Participants

PRIMARY outcome

Timeframe: 12 months

Population: numbers analyzed in each row show all the participants at the two timepoints (baseline and 12 month) for which data exists.

Change in 12-month Systolic Blood Pressure (SBP)

Outcome measures

Outcome measures
Measure
Arm 1
n=62 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
n=60 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
n=63 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
n=61 Participants
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
n=58 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
n=61 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
n=64 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
n=59 Participants
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Change in Mean Systolic Blood Pressure
Mean @ Baseline
142.8 mmHg
Interval 138.7 to 146.9
146.8 mmHg
Interval 142.1 to 151.6
143.9 mmHg
Interval 139.6 to 148.2
144.7 mmHg
Interval 140.0 to 149.5
148 mmHg
Interval 142.5 to 153.5
145.8 mmHg
Interval 140.4 to 151.1
147.4 mmHg
Interval 142.6 to 152.1
149 mmHg
Interval 143.5 to 154.5
Change in Mean Systolic Blood Pressure
Mean of Median SBP @ 12 months
135.1 mmHg
Interval 127.7 to 142.4
136.8 mmHg
Interval 130.7 to 143.0
138.2 mmHg
Interval 129.7 to 146.7
135.4 mmHg
Interval 130.0 to 140.9
136.9 mmHg
Interval 130.5 to 143.2
138.8 mmHg
Interval 131.3 to 146.4
139 mmHg
Interval 131.6 to 146.4
138.5 mmHg
Interval 129.3 to 147.6
Change in Mean Systolic Blood Pressure
Mean Change from Baseline
-8.8 mmHg
Interval -15.0 to -2.6
-8 mmHg
Interval -15.3 to -0.7
-3.2 mmHg
Interval -10.1 to 3.7
-8.8 mmHg
Interval -18.1 to 0.5
-7.3 mmHg
Interval -15.6 to 1.1
-5.4 mmHg
Interval -12.3 to 1.6
-6 mmHg
Interval -15.7 to 3.7
-4.9 mmHg
Interval -15.8 to 5.9

SECONDARY outcome

Timeframe: Baseline ED visit (in days)

Population: 211 is all of the participants in each of the eight arms who completed

Utilizing multivariable Cox regression analysis, the relationship between mHealth components and attendance at initial Primary Care Physician (PCP) appointment after Emergency Department visit is explored. The analysis adjusts for age, sex, race, presence of a primary care provider, and usage of blood pressure medications. The Hazard Ratio in this context is a measure indicating the relative risk of experiencing the event of interest (time to first PCP visit). A Hazard Ratio greater than 1 implies a greater risk of receipt of a first PCP appointment, and a Hazard Ratio less than 1 implies a lower risk of receipt of a first PCP appointment within 12-month follow-up. The use of Hazard Ratio in this context allows for the assessment of the impact of mHealth components on the timing of primary care engagement while accounting for potential confounding variables. This allows more valuable insights into the effectiveness of these components in facilitating access to primary care visits.

Outcome measures

Outcome measures
Measure
Arm 1
n=211 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
n=211 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
n=211 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Hazard Ratio Analysis of Participant Time From Enrollment Emergency Department Visit to the First PCP Visit
0.9 hazard ratio
Interval 0.7 to 1.3
1.2 hazard ratio
Interval 0.9 to 1.6
1.2 hazard ratio
Interval 0.9 to 1.6

SECONDARY outcome

Timeframe: 12 months

Utilizing logistic regression analysis, the probability of participants attending 2 or more primary care visits within a 12-month period is explored. The analysis adjusts for age, sex, race, presence of a primary care provider, and usage of blood pressure medications. The Odds Ratio in this context indicates the likelihood of an event occurring. A higher Odds Ratio suggests an increased likelihood of attending multiple primary care visits, while a lower Odds Ratio indicates a decreased likelihood. The use of Odds Ratio in this context is justified as it allows for the comparison of the likelihood of attending two or more primary care while accounting for covariates. This is useful in logistic regression analysis, where the outcome variable is binary (i.e., attending two or more primary care visits or not) and the focus is on understanding the association between predictor variables and the probability of the outcome.

Outcome measures

Outcome measures
Measure
Arm 1
n=211 Participants
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
n=211 Participants
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
n=211 Participants
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments
Odds Ratio Analysis of Participants Completing 2 or More Primary Care Visits
0.7 Odds Ratio
Interval 0.4 to 1.4
1.8 Odds Ratio
Interval 0.9 to 3.6
1.7 Odds Ratio
Interval 0.9 to 3.5

Adverse Events

Arm 8

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Arm 5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 6

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 7

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Michigan

Phone: 734-615-2766

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place