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)
COMPLETED
NA
488 participants
12 months
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
| 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
| 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
| 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 monthsPopulation: 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
| 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
| 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 monthsUtilizing 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
| 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
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place