Trial Outcomes & Findings for Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease (NCT NCT04858295)
NCT ID: NCT04858295
Last Updated: 2025-11-17
Results Overview
Composite outcome determined by participant retention rate, any use of the SMART-HABITS dashboard; Good adoption will be determined by greater than or equal to 70 percent of those retained in the study, and greater than or equal to 70 percent of those enrolled who actually used SMART-HABITS dashboard/web app as measured by data usage statistics.
COMPLETED
NA
47 participants
Collected throughout study (12 weeks)
2025-11-17
Participant Flow
47 of 221 screened participants were randomized. Of those not randomized 40 declined to participate, and 134 did not meet inclusion criteria.
Participant milestones
| Measure |
Text Message and Then mHealth App Arm
Participants will receive automated text message reminders to check their blood pressure (BP) at least three days per week (participants will choose which days and times to receive reminders). Participants will transmit BP readings with text message to the Way to Health server. If a BP reading is not received within 3 hours, another reminder will be sent. Automated text message feedback will be sent with a tailored message. Participants will asked to set a daily step goal of at least 3,000 steps per day and transmit their step count information from their FitBit. Participants will be reminded once a day to sync their FitBit. Motivating messages will be sent weekly. After 4 weeks, and 8 weeks of the study, a usability survey will be sent. Weekly and daily feedback will be sent. At the conclusion of week 6, individuals will "crossover" and will continue for an additional 6 weeks using the mHealth app to communicate BP readings.
Texting: The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail, voice), self-administered surveys, and secure data capture for research purposes. Way to Health has been used successfully in prior behavior intervention studies.
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mHealth App Then Texting Arm
Participants randomized to the mHealth app (Omron Connect) arm will receive reminder messages to check their BP via push notifications from the Omron Connect app at least three times weekly. Upon receipt of the BP reading to the research platform from Omron Connect, participants will receive automatic tailored text message feedback similar to the texting arm. Participants will asked to set a daily step goal of at least 3,000 steps per day and transmit their step count information from their FitBit. Participants will be reminded once a day to sync their FitBit. Motivating messages will be sent weekly. After 4 weeks, and 8 weeks of the study, a usability survey will be sent. Weekly and daily feedback will be sent. At the conclusion of week 6, individuals will "crossover" and will continue for an additional 6 weeks using the text message to communicate BP readings.
mHealth app: Omron Connect app available on a participant's smartphone connects to the participant's home Omron blood pressure monitor via bluetooth technology. The Omron Connect app, which stores the blood pressure readings and provides reminders to the participant via push notifications also communicates with the Way to Health research platform via Internet connection.
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|---|---|---|
|
All Study Participants
STARTED
|
23
|
24
|
|
All Study Participants
Received Intervention
|
23
|
23
|
|
All Study Participants
COMPLETED
|
22
|
21
|
|
All Study Participants
NOT COMPLETED
|
1
|
3
|
|
First Intervention (6 Weeks)
STARTED
|
23
|
24
|
|
First Intervention (6 Weeks)
Received Intervention
|
23
|
23
|
|
First Intervention (6 Weeks)
COMPLETED
|
23
|
21
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
0
|
3
|
|
Second Intervention (6 Weeks)
STARTED
|
23
|
21
|
|
Second Intervention (6 Weeks)
COMPLETED
|
22
|
21
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=47 Participants
All study participants were randomized to two approaches to communicate home blood pressure readings, with an mHealth app (Omron Connect) for 6 weeks and with text messages for the alternate 6 weeks.
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|---|---|
|
Employment Status
Employed
|
16 Participants
n=202 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=202 Participants
|
|
Age, Continuous
|
63 years
n=202 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/Alaskan Native
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
21 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White or Caucasian
|
23 Participants
n=202 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=202 Participants
|
|
Highest Level of Education
≤High school
|
6 Participants
n=202 Participants
|
|
Highest Level of Education
Some college
|
14 Participants
n=202 Participants
|
|
Highest Level of Education
College or more
|
27 Participants
n=202 Participants
|
|
Employment Status
Not Employed
|
4 Participants
n=202 Participants
|
|
Employment Status
Retired
|
20 Participants
n=202 Participants
|
|
Employment Status
Unable to work/disabled
|
7 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Collected throughout study (12 weeks)Population: Participants randomized to intervention sequence.
Composite outcome determined by participant retention rate, any use of the SMART-HABITS dashboard; Good adoption will be determined by greater than or equal to 70 percent of those retained in the study, and greater than or equal to 70 percent of those enrolled who actually used SMART-HABITS dashboard/web app as measured by data usage statistics.
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
n=47 Participants
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
|
Feasibility: Adoption
Retention
|
44 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Feasibility: Adoption
Any use of SMART-HABITS
|
18 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Collected throughout study (12 weeks)Population: Participants receiving intervention
Determined by the number of blood pressure assessments and step counts performed divided by the number of assessments recommended. Good adherence will be determined by greater than or equal to 70 percent performed out of the recommended.
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
n=47 Participants
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
|
Feasibility: Adherence
Adherence to 3 or more BP transmissions per week
|
36 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Feasibility: Adherence
Adherence to 5 or more daily step count transmissions per week
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms after the crossover, so all study participants who completed the end of study questionnaire were analyzed together regardless of arm.
Determined through change in pre- and post-study scores on the three attitude statements toward mHealth, entitled Attitudes Toward Mobile Phone-Based Health Monitoring. Answers reported on 5-point Likert scale ranging from 1= strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, to 5 = strongly agree (total range 3-15), with higher scores indicating better acceptability. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Outcome measures
| Measure |
Per Intervention: Text Message
n=42 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
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Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)
|
12 score on a scale
Interval 10.0 to 14.0
|
—
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—
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—
|
—
|
—
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PRIMARY outcome
Timeframe: 4 weeks, 8 weeks, 12 weeksPopulation: participants completing questionnaire at 4-weeks, 8 weeks and 12 weeks.
Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).
Outcome measures
| Measure |
Per Intervention: Text Message
n=23 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
n=24 Participants
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
n=23 Participants
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
n=16 Participants
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
n=23 Participants
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
n=24 Participants
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
|
Feasibility: Acceptability of SMART-HABITS
|
77 score on a scale
Standard Deviation 16.2
|
64.5 score on a scale
Standard Deviation 19.7
|
70.1 score on a scale
Standard Deviation 14.8
|
65.9 score on a scale
Standard Deviation 19.4
|
71.6 score on a scale
Standard Deviation 16.4
|
65.6 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms of the crossover, so all study participants who completed the end of study questionnaire were analyzed together regardless of arm.
Determined by change in pre-pilot and post-pilot scores on responses regarding CKD knowledge using the 28-question Kidney Knowledge Survey (KiKS). The survey score is defined the percentage correct responses to each answered question divided by the total, total range 0-100%. Higher percentages indicate better knowledge. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Outcome measures
| Measure |
Per Intervention: Text Message
n=38 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
|
66.7 score on a scale
Interval 66.6 to 66.8
|
—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms of the crossover, so all study participants who completed the end of study Self-Efficacy for Management Chronic Disease survey were analyzed together regardless of arm.
Determined by change in pre-pilot and post-pilot scores on responses regarding self-efficacy using the Self-Efficacy for Managing Chronic Disease 6-Item Scale. Answer range from 1 = not at all confident to 10= totally confident, with higher scores indicating higher self-efficacy.
Outcome measures
| Measure |
Per Intervention: Text Message
n=38 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
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Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
|
7.8 score on a scale
Interval 6.95 to 8.65
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms of the crossover, so all study participants who completed the end of study Partners in Health Scale for Chronic Condition Self-management were analyzed together regardless of arm.
Determined by change in pre-pilot and post-pilot scores on responses regarding self-management using the Partners in Health Scale for Chronic Condition Self-Management (11 items). Answers range on a linear scale provided: very good=0, 1, 2, 3, 4=satisfactory, 5, 6, 7, 8= very poor. Total range of scores 0-88, with higher scores indicating better self-management.
Outcome measures
| Measure |
Per Intervention: Text Message
n=40 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
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|---|---|---|---|---|---|---|
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Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
|
72 score on a scale
Interval 64.5 to 79.5
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms of the crossover, so all study participants who completed the end of study eHealth Literacy Scale (eHEALS) were analyzed together regardless of arm.
Determined by change in pre-pilot and post-pilot scores on responses regarding eHealth literacy Scale (eHEALS). eHEALS consists of eight questions with 5 response options on a Likert-scale, and scored as a cumulative score of the eight questions (total range 8-40) with higher scores indicating better eHealth literacy (a score of ≥32 is considered to be adequate eHealth literacy).
Outcome measures
| Measure |
Per Intervention: Text Message
n=42 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
|
30.5 score on a scale
Interval 27.6 to 33.4
|
—
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) so all participants had completed both arms of the crossover, so all study participants who completed the end of study KDQOL-36 were analyzed together regardless of arm.
Determined by change in pre-pilot and post-pilot scores on responses regarding disease-related quality of life using the Kidney Disease Quality of Life 36-item survey (KDQOL-36). Scores are reported separately for each of the three KDQOL-36 subscales: Symptoms and Problems (12 items), Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items); all items have 5 response options. Each sub-scale scores are transformed to 0 to 100 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Per Intervention: Text Message
n=42 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Burden of Kidney Disease
|
77.5 score on a scale
Standard Deviation 23.9
|
—
|
—
|
—
|
—
|
—
|
|
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Effects of Kidney Disease
|
83.4 score on a scale
Standard Deviation 24.4
|
—
|
—
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—
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—
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—
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|
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Symptoms/Problems
|
85.9 score on a scale
Standard Deviation 21.4
|
—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 4, 8, and 12 weeksPopulation: All study participants randomized.
Mean systolic blood pressure after 4, 8, and 12 weeks
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
n=47 Participants
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Effectiveness of Home Monitoring of BP
SBP at 8 weeks
|
125 mmHg
Standard Deviation 10
|
129 mmHg
Standard Deviation 12
|
—
|
—
|
—
|
—
|
|
Effectiveness of Home Monitoring of BP
SBP at 12 weeks
|
126 mmHg
Standard Deviation 9
|
129 mmHg
Standard Deviation 14
|
—
|
—
|
—
|
—
|
|
Effectiveness of Home Monitoring of BP
SBP at 4 weeks
|
125 mmHg
Standard Deviation 9
|
130 mmHg
Standard Deviation 12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4, 8, and 12 weeksPopulation: The outcome measure was collected on daily basis regardless of BP communication arm at 4-, 8-, and 12 weeks.
Mean step count in first week, and after 4, 8, and 12 weeks.
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
n=47 Participants
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Effectiveness of Step Monitoring
Daily steps in week 12
|
6515 daily steps
Standard Deviation 3994
|
6153 daily steps
Standard Deviation 3282
|
—
|
—
|
—
|
—
|
|
Effectiveness of Step Monitoring
Daily steps in week 1
|
6846 daily steps
Standard Deviation 3902
|
5897 daily steps
Standard Deviation 3541
|
—
|
—
|
—
|
—
|
|
Effectiveness of Step Monitoring
Daily steps in week 4
|
6758 daily steps
Standard Deviation 4142
|
6250 daily steps
Standard Deviation 3400
|
—
|
—
|
—
|
—
|
|
Effectiveness of Step Monitoring
Daily steps in week 8
|
7387 daily steps
Standard Deviation 4614
|
6106 daily steps
Standard Deviation 4081
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The outcome measure was collected at 12 weeks (end of study) regardless of arm and BP communication mode so participants were analyzed regardless of arm.
Determined by transmitting at least one BP monitored reading or daily step count each week.
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksQualitative reports describing adaptions that were made to the SMART-HABITS program in response to participant feedback, including descriptions of alterations that were made to the schedule of reminders and messaging content. Participant feedback data will be collected with field notes from verbal conversations and textual data from email and text messages.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of randomizationPopulation: Compare the frequency of demographic characteristic of all participants randomized to that of published frequency of demographics of the US population with CKD
Sex frequency of randomized participants compared to the published sex frequency of the US population with CKD (female approximately 55%)
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Reach: Qualitatively Similar Frequency of the Sex Distribution of Participants in the Study at the Time of Randomization vs. Published Information on the US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Female
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reach: Qualitatively Similar Frequency of the Sex Distribution of Participants in the Study at the Time of Randomization vs. Published Information on the US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Male
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of randomizationPopulation: Randomized participants
Frequency of race groups (Black, White other) of participants at time of randomization compared to the approximate frequency---- of the US population with CKD (black race group = 18%, white race group = 75%)
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Black
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
White
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
American Indian/Alaskan Native
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Asian
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrolled and randomizedPopulation: Participants who were randomized
Determined by the comparison of ethnicity (Hispanic, Non-Hispanic) frequency (percentage) of the randomized participants compared to ethnicity frequency of the general population with chronic kidney disease stage in the United States (Hispanic = \~13%).
Outcome measures
| Measure |
Per Intervention: Text Message
n=47 Participants
Participants assigned to self-report home blood pressure readings for 6 weeks with text message.
|
Per Intervention: mHealth App
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine.
|
Text Message Then mHealth App (at 8 Weeks)
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 8 weeks.
|
mHealth App Then to Text Message (at 8 Weeks)
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 8 weeks.
|
12 Week Usability Survey of Those Who Received Text Message Arm First
Study participants randomized to text message first and crossed over at 6 weeks to mHealth app who completed survey at 12 weeks.
|
12 Week Usability Survey of Those Two Received mHealth Arm First
Study participants randomized to mHealth app first and crossed over at 6 weeks to text message who completed usability survey at 12 weeks.
|
|---|---|---|---|---|---|---|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Ethnic Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Hispanic ethnicity
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reach: Qualitatively Similar Frequency (Percentage) of the Ethnic Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Non-Hispanic
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Texting Arm
mHealth App Arm
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