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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK118198-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Texting Arm | Active Comparator | 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 opposite technology to communicate BP readings. |
|
| mHealth app Arm | Active Comparator | 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 opposite technology to communicate BP readings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Texting | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected throughout study (12 weeks) |
| 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. | Collected throughout study (12 weeks) |
| 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. | 12 weeks |
| 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). | 4 weeks, 8 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Schrauben, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38954482 | Derived | Schrauben SJ, Park D, Amaral S, Purcell A, Zhang S, Kearney M, Bilger A, Feldman HI, Dember LM. Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease and Hypertension: The Supporting Self-Management of Healthy Behaviors Pilot Randomized Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1109-1118. doi: 10.2215/CJN.0000000000000492. Epub 2024 Jul 2. |
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To be determined
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47 of 221 screened participants were randomized. Of those not randomized 40 declined to participate, and 134 did not meet inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Study Participants |
| ||||||||||||||||
| First Intervention (6 Weeks) |
| ||||||||||||||||
| Second Intervention (6 Weeks) |
|
All participants randomized in the cross-over trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants randomized to intervention sequence. | Posted | Count of Participants | Participants | Collected throughout study (12 weeks) |
|
Adverse event data was collected for the entire study duration (12 weeks) for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Texting 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 opposite technology 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Schrauben | University of Pennsylvania | 267-324-7588 | sarahsch@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 2, 2021 | Aug 29, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
|
| mHealth app | Device | 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. |
|
|
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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). | 12 weeks |
| 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. | 12 weeks |
| Effectiveness of Home Monitoring of BP | Mean systolic blood pressure after 4, 8, and 12 weeks | 4, 8, and 12 weeks |
| Effectiveness of Step Monitoring | Mean step count in first week, and after 4, 8, and 12 weeks. | 4, 8, and 12 weeks |
| Maintenance | Determined by transmitting at least one BP monitored reading or daily step count each week. | 12 weeks |
| 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. | 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 | Sex frequency of randomized participants compared to the published sex frequency of the US population with CKD (female approximately 55%) | At the time of randomization |
| 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%) | At time of randomization |
| 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%). | Enrolled and randomized |
| COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
| No |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
Participants assigned to report home blood pressure readings for 6 weeks with a smartphone app paired with a Bluetooth-capable blood pressure machine. |
|
|
| 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. | Participants receiving intervention | Posted | Count of Participants | Participants | Collected throughout study (12 weeks) |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| 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). | participants completing questionnaire at 4-weeks, 8 weeks and 12 weeks. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 8 weeks, 12 weeks |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Effectiveness of Home Monitoring of BP | Mean systolic blood pressure after 4, 8, and 12 weeks | All study participants randomized. | Posted | Mean | Standard Deviation | mmHg | 4, 8, and 12 weeks |
|
|
|
| Secondary | Effectiveness of Step Monitoring | Mean step count in first week, and after 4, 8, and 12 weeks. | The outcome measure was collected on daily basis regardless of BP communication arm at 4-, 8-, and 12 weeks. | Posted | Mean | Standard Deviation | daily steps | 4, 8, and 12 weeks |
|
|
|
| Secondary | Maintenance | Determined by transmitting at least one BP monitored reading or daily step count each week. | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 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. | Not Posted | 12 weeks | 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%) | Compare the frequency of demographic characteristic of all participants randomized to that of published frequency of demographics of the US population with CKD | Posted | Count of Participants | Participants | At the time of randomization |
|
|
|
| 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%) | Randomized participants | Posted | Count of Participants | Participants | At time of randomization |
|
|
|
| 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%). | Participants who were randomized | Posted | Count of Participants | Participants | Enrolled and randomized |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | mHealth App 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 opposite technology 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. | 0 | 47 | 0 | 47 | 0 | 47 |
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| SBP at 12 weeks |
|
| Daily steps in week 8 |
|
| Daily steps in week 12 |
|
| Asian |
|