Hypertension, Renal Insufficiency, Chronic
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Adoption | Collected 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: Adherence | Collected 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 weeks | 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. |
| Feasibility: Acceptability of SMART-HABITS | 4 weeks, 8 weeks, 12 weeks | Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study) | 12 weeks | 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. |
| Effectiveness of Home Monitoring of BP | 4, 8, and 12 weeks | Mean systolic blood pressure after 4, 8, and 12 weeks |
| Effectiveness of Step Monitoring | 4, 8, and 12 weeks | Mean step count in first week, and after 4, 8, and 12 weeks. |
| Maintenance | 12 weeks | Determined 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 weeks | 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. |
| 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 | At the time of randomization | Sex 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 Hypertension | At time of randomization | 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%) |
| 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 | Enrolled and 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%). |
| Implementation Issues | 12 weeks | 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. |
| Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 12 weeks | 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. |
| Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 12 weeks | 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. |
| Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 12 weeks | 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). |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 47 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 63 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Intervention: Text Message | Feasibility: Acceptability of SMART-HABITS | 77 score on a scale | Standard Deviation 16.2 |
| Per Intervention: mHealth App | Feasibility: Acceptability of SMART-HABITS | 64.5 score on a scale | Standard Deviation 19.7 |
| Text Message Then mHealth App (at 8 Weeks) | Feasibility: Acceptability of SMART-HABITS | 70.1 score on a scale | Standard Deviation 14.8 |
| mHealth App Then to Text Message (at 8 Weeks) | Feasibility: Acceptability of SMART-HABITS | 65.9 score on a scale | Standard Deviation 19.4 |
| 12 Week Usability Survey of Those Who Received Text Message Arm First | Feasibility: Acceptability of SMART-HABITS | 71.6 score on a scale | Standard Deviation 16.4 |
| 12 Week Usability Survey of Those Two Received mHealth Arm First | Feasibility: Acceptability of SMART-HABITS | 65.6 score on a scale | Standard Deviation 21.7 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Per Intervention: Text Message | Feasibility: Adherence | Adherence to 3 or more BP transmissions per week | 36 Participants |
| Per Intervention: Text Message | Feasibility: Adherence | Adherence to 5 or more daily step count transmissions per week | 43 Participants |
| Per Intervention: mHealth App | Feasibility: Adherence | Adherence to 3 or more BP transmissions per week | 30 Participants |
| Per Intervention: mHealth App | Feasibility: Adherence | Adherence to 5 or more daily step count transmissions per week | 43 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Per Intervention: Text Message | Feasibility: Adoption | Any use of SMART-HABITS | 18 Participants |
| Per Intervention: Text Message | Feasibility: Adoption | Retention | 44 Participants |
| Per Intervention: mHealth App | Feasibility: Adoption | Retention | 42 Participants |
| Per Intervention: mHealth App | Feasibility: Adoption | Any use of SMART-HABITS | 22 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Per Intervention: Text Message | Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study) | 12 score on a scale |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Per Intervention: Text Message | Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 66.7 score on a scale |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Per Intervention: Text Message | Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 30.5 score on a scale |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Per Intervention: Text Message | Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 7.8 score on a scale |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Per Intervention: Text Message | Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study) | 72 score on a scale |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Intervention: Text Message | Effectiveness of Home Monitoring of BP | SBP at 4 weeks | 125 mmHg | Standard Deviation 9 |
| Per Intervention: Text Message | Effectiveness of Home Monitoring of BP | SBP at 8 weeks | 125 mmHg | Standard Deviation 10 |
| Per Intervention: Text Message | Effectiveness of Home Monitoring of BP | SBP at 12 weeks | 126 mmHg | Standard Deviation 9 |
| Per Intervention: mHealth App | Effectiveness of Home Monitoring of BP | SBP at 4 weeks | 130 mmHg | Standard Deviation 12 |
| Per Intervention: mHealth App | Effectiveness of Home Monitoring of BP | SBP at 8 weeks | 129 mmHg | Standard Deviation 12 |
| Per Intervention: mHealth App | Effectiveness of Home Monitoring of BP | SBP at 12 weeks | 129 mmHg | Standard Deviation 14 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per Intervention: Text Message | Effectiveness of Step Monitoring | Daily steps in week 1 | 6846 daily steps | Standard Deviation 3902 |
| Per Intervention: Text Message | Effectiveness of Step Monitoring | Daily steps in week 8 | 7387 daily steps | Standard Deviation 4614 |
| Per Intervention: Text Message | Effectiveness of Step Monitoring | Daily steps in week 12 | 6515 daily steps | Standard Deviation 3994 |
| Per Intervention: Text Message | Effectiveness of Step Monitoring | Daily steps in week 4 | 6758 daily steps | Standard Deviation 4142 |
| Per Intervention: mHealth App | Effectiveness of Step Monitoring | Daily steps in week 12 | 6153 daily steps | Standard Deviation 3282 |
| Per Intervention: mHealth App | Effectiveness of Step Monitoring | Daily steps in week 1 | 5897 daily steps | Standard Deviation 3541 |
| Per Intervention: mHealth App | Effectiveness of Step Monitoring | Daily steps in week 4 | 6250 daily steps | Standard Deviation 3400 |
| Per Intervention: mHealth App | Effectiveness of Step Monitoring | Daily steps in week 8 | 6106 daily steps | Standard Deviation 4081 |
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per Intervention: Text Message | Maintenance | 43 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
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |
| Per Intervention: Text Message | 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 |