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Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease

A Pilot Trial of the Feasibility of a Patient-Centered Mobile Health Self-Management Support Tool for Healthy Behaviors (SMART-HABITS) in Chronic Kidney Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04858295
Acronym
SMART-HABITS
Enrollment
47
Registered
2021-04-26
Start date
2021-07-26
Completion date
2023-05-01
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renal Insufficiency, Chronic

Brief summary

The pilot cross-over study aims to examine the feasibility of a smartphone-based self-management supportive intervention, Supporting Self-Management of Healthy Behaviors (SMART-HABITS) in patients with chronic kidney disease (CKD) and hypertension. SMART-HABITS is a web-based application accessible on any device that has Internet access and utilizes a mobile health research platform (Way to Health) that links to wearable sensor smartphone applications such as FitBit and Omron Connect, to provide reminders, tailored feedback, and provide access to educational resources, and to community resources. The cross-over design is used to test preferences of using text message or a smartphone app to communicate blood pressure readings.

Detailed description

The pilot study aims to examine the feasibility, as measured by adoption, adherence, and acceptance, of a smartphone-based self-management supportive intervention, Supporting Self-Management of Healthy Behaviors (SMART-HABITS) in patients with chronic kidney disease (CKD) and hypertension. SMART-HABITS is a web-based application accessible on any device that has Internet access and utilizes the mobile health research platform to provide the components of the intervention: a) text message reminders (Arm 1), b) text message tailored feedback (Arm 1 and 2), c) positive affirmation text messages (Arms 1 and 2), d) access to educational resources, community resources, CKD patient forums (Arms 1 and 2), e) option to select a accountability partner to share reminders and feedback (Arms 1 and 2). SMART-HABITS encompasses multiple behavior change techniques and is centered on the Health Belief Model and the Social Cognitive Theory. SMART-HABITS will deliver reminder text messages to a participant's smartphone to perform blood pressure self-monitoring in one arm and encourage an increase in walking activity both arms. The Omron Connect app will deliver the reminder notifications to check blood pressure and will deliver the BP readings to research platform (in the non-texting arm). After blood pressure measurements and daily step counts are remotely transmitted from the smartphone to mobile health research platform server, tailored feedback will be provided via text message). Additionally, intermittent positive affirmation messages will also be sent to participants to encourage engagement in the behaviors. Within the SMART-HABITS web-based application, there will be a participant portal that will provide access to links to community resources, educational links about CKD, and a display of adherence to behaviors and data transmission. At the beginning and end of the study, questionnaires will be completed to assess patient-reported outcomes, which will serve as secondary endpoints.

Interventions

DEVICETexting

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.

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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients with hypertension (treated with three or less anti-hypertensive medications) and chronic kidney disease stage 3 or 4 managed in participating nephrology practices * have a smartphone that they are willing to carry with them the majority of the time while enrolled in the study * able to comprehend English, * have ability to walk. * mean blood pressure of \<=180/100 mmHg from historical blood pressure readings in the electronic medical record * able and willing to provide informed consent

Exclusion criteria

* inability to provide consent or read or speak English * had MI or stroke within the previous six months, * diagnosis of dementia or cognitive impairment * inability to walk * already participating in another physical activity study * belong to vulnerable population * likely to receive a kidney transplant within 1 month of enrollment into the trial * living in a long-term care or rehabilitation institution * likely to have their care transferred to another facility outside participating clinic areas during the course of the study * planning to travel or live consecutively out of the country for more than one month * participating in another intervention trial, * hypertension not managed by the nephrologist in the clinic * prescribed more than three anti-hypertensive medications (i.e. resistant hypertension), * any other reason they do not expect to be able to complete the study.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: AdoptionCollected throughout study (12 weeks)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.
Feasibility: AdherenceCollected throughout study (12 weeks)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.
Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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.
Feasibility: Acceptability of SMART-HABITS4 weeks, 8 weeks, 12 weeksDetermined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).

Secondary

MeasureTime frameDescription
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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.
Effectiveness of Home Monitoring of BP4, 8, and 12 weeksMean systolic blood pressure after 4, 8, and 12 weeks
Effectiveness of Step Monitoring4, 8, and 12 weeksMean step count in first week, and after 4, 8, and 12 weeks.
Maintenance12 weeksDetermined by transmitting at least one BP monitored reading or daily step count each week.
Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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.
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 HypertensionAt the time of randomizationSex frequency of randomized participants compared to the published sex frequency of the US population with CKD (female approximately 55%)
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 HypertensionAt time of randomizationFrequency 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%)
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 HypertensionEnrolled and randomizedDetermined 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%).
Implementation Issues12 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.
Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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.
Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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.
Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)12 weeksDetermined 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).

Countries

United States

Participant flow

Pre-assignment details

47 of 221 screened participants were randomized. Of those not randomized 40 declined to participate, and 134 did not meet inclusion criteria.

Participants by arm

ArmCount
All Study 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.
47
Total47

Baseline characteristics

CharacteristicAll Study Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
21 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Age, Continuous63 years
Employment Status
Employed
16 Participants
Employment Status
Not Employed
4 Participants
Employment Status
Retired
20 Participants
Employment Status
Unable to work/disabled
7 Participants
Highest Level of Education
College or more
27 Participants
Highest Level of Education
≤High school
6 Participants
Highest Level of Education
Some college
14 Participants
Race/Ethnicity, Customized
Race/Ethnicity
American Indian/Alaskan Native
1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian
2 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black or African American
21 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White or Caucasian
23 Participants
Region of Enrollment
United States
47 Participants
Sex: Female, Male
Female
23 Participants
Sex: Female, Male
Male
24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 470 / 47
other
Total, other adverse events
0 / 470 / 47
serious
Total, serious adverse events
0 / 470 / 47

Outcome results

Primary

Feasibility: Acceptability of SMART-HABITS

Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).

Time frame: 4 weeks, 8 weeks, 12 weeks

Population: participants completing questionnaire at 4-weeks, 8 weeks and 12 weeks.

ArmMeasureValue (MEAN)Dispersion
Per Intervention: Text MessageFeasibility: Acceptability of SMART-HABITS77 score on a scaleStandard Deviation 16.2
Per Intervention: mHealth AppFeasibility: Acceptability of SMART-HABITS64.5 score on a scaleStandard Deviation 19.7
Text Message Then mHealth App (at 8 Weeks)Feasibility: Acceptability of SMART-HABITS70.1 score on a scaleStandard Deviation 14.8
mHealth App Then to Text Message (at 8 Weeks)Feasibility: Acceptability of SMART-HABITS65.9 score on a scaleStandard Deviation 19.4
12 Week Usability Survey of Those Who Received Text Message Arm FirstFeasibility: Acceptability of SMART-HABITS71.6 score on a scaleStandard Deviation 16.4
12 Week Usability Survey of Those Two Received mHealth Arm FirstFeasibility: Acceptability of SMART-HABITS65.6 score on a scaleStandard Deviation 21.7
Primary

Feasibility: Adherence

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.

Time frame: Collected throughout study (12 weeks)

Population: Participants receiving intervention

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageFeasibility: AdherenceAdherence to 3 or more BP transmissions per week36 Participants
Per Intervention: Text MessageFeasibility: AdherenceAdherence to 5 or more daily step count transmissions per week43 Participants
Per Intervention: mHealth AppFeasibility: AdherenceAdherence to 3 or more BP transmissions per week30 Participants
Per Intervention: mHealth AppFeasibility: AdherenceAdherence to 5 or more daily step count transmissions per week43 Participants
Primary

Feasibility: Adoption

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.

Time frame: Collected throughout study (12 weeks)

Population: Participants randomized to intervention sequence.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageFeasibility: AdoptionAny use of SMART-HABITS18 Participants
Per Intervention: Text MessageFeasibility: AdoptionRetention44 Participants
Per Intervention: mHealth AppFeasibility: AdoptionRetention42 Participants
Per Intervention: mHealth AppFeasibility: AdoptionAny use of SMART-HABITS22 Participants
Primary

Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)

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.

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
Per Intervention: Text MessageFeasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)12 score on a scale
Secondary

Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

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.

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
Per Intervention: Text MessageChange in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)66.7 score on a scale
Secondary

Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

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).

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
Per Intervention: Text MessageChange in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)30.5 score on a scale
Secondary

Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)

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.

Time frame: 12 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Per Intervention: Text MessageChange in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)Burden of Kidney Disease77.5 score on a scaleStandard Deviation 23.9
Per Intervention: Text MessageChange in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)Effects of Kidney Disease83.4 score on a scaleStandard Deviation 24.4
Per Intervention: Text MessageChange in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)Symptoms/Problems85.9 score on a scaleStandard Deviation 21.4
Secondary

Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

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.

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
Per Intervention: Text MessageChange in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)7.8 score on a scale
Secondary

Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

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.

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
Per Intervention: Text MessageChange in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)72 score on a scale
Secondary

Effectiveness of Home Monitoring of BP

Mean systolic blood pressure after 4, 8, and 12 weeks

Time frame: 4, 8, and 12 weeks

Population: All study participants randomized.

ArmMeasureGroupValue (MEAN)Dispersion
Per Intervention: Text MessageEffectiveness of Home Monitoring of BPSBP at 4 weeks125 mmHgStandard Deviation 9
Per Intervention: Text MessageEffectiveness of Home Monitoring of BPSBP at 8 weeks125 mmHgStandard Deviation 10
Per Intervention: Text MessageEffectiveness of Home Monitoring of BPSBP at 12 weeks126 mmHgStandard Deviation 9
Per Intervention: mHealth AppEffectiveness of Home Monitoring of BPSBP at 4 weeks130 mmHgStandard Deviation 12
Per Intervention: mHealth AppEffectiveness of Home Monitoring of BPSBP at 8 weeks129 mmHgStandard Deviation 12
Per Intervention: mHealth AppEffectiveness of Home Monitoring of BPSBP at 12 weeks129 mmHgStandard Deviation 14
Secondary

Effectiveness of Step Monitoring

Mean step count in first week, and after 4, 8, and 12 weeks.

Time frame: 4, 8, and 12 weeks

Population: The outcome measure was collected on daily basis regardless of BP communication arm at 4-, 8-, and 12 weeks.

ArmMeasureGroupValue (MEAN)Dispersion
Per Intervention: Text MessageEffectiveness of Step MonitoringDaily steps in week 16846 daily stepsStandard Deviation 3902
Per Intervention: Text MessageEffectiveness of Step MonitoringDaily steps in week 87387 daily stepsStandard Deviation 4614
Per Intervention: Text MessageEffectiveness of Step MonitoringDaily steps in week 126515 daily stepsStandard Deviation 3994
Per Intervention: Text MessageEffectiveness of Step MonitoringDaily steps in week 46758 daily stepsStandard Deviation 4142
Per Intervention: mHealth AppEffectiveness of Step MonitoringDaily steps in week 126153 daily stepsStandard Deviation 3282
Per Intervention: mHealth AppEffectiveness of Step MonitoringDaily steps in week 15897 daily stepsStandard Deviation 3541
Per Intervention: mHealth AppEffectiveness of Step MonitoringDaily steps in week 46250 daily stepsStandard Deviation 3400
Per Intervention: mHealth AppEffectiveness of Step MonitoringDaily steps in week 86106 daily stepsStandard Deviation 4081
Secondary

Implementation Issues

Qualitative 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.

Time frame: 12 weeks

Secondary

Maintenance

Determined by transmitting at least one BP monitored reading or daily step count each week.

Time frame: 12 weeks

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageMaintenance43 Participants
Secondary

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

Sex frequency of randomized participants compared to the published sex frequency of the US population with CKD (female approximately 55%)

Time frame: At the time of randomization

Population: Compare the frequency of demographic characteristic of all participants randomized to that of published frequency of demographics of the US population with CKD

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageReach: 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 HypertensionFemale23 Participants
Per Intervention: Text MessageReach: 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 HypertensionMale24 Participants
Secondary

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

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%).

Time frame: Enrolled and randomized

Population: Participants who were randomized

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageReach: 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 HypertensionHispanic ethnicity1 Participants
Per Intervention: Text MessageReach: 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 HypertensionNon-Hispanic46 Participants
Secondary

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

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%)

Time frame: At time of randomization

Population: Randomized participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Per Intervention: Text MessageReach: 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 HypertensionBlack21 Participants
Per Intervention: Text MessageReach: 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 HypertensionWhite23 Participants
Per Intervention: Text MessageReach: 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 HypertensionAmerican Indian/Alaskan Native1 Participants
Per Intervention: Text MessageReach: 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 HypertensionAsian2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026