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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK118198 | 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 planned intervention, entitled, Supporting Self-Management of Health Behaviors to Optimize Health (SMART-HABITS for Health), aims to provide support for patients with chronic kidney disease (CKD), hypertension and diabetes by providing text messages delivered as motivational reminders and support to encourage blood pressure self-monitoring through goal setting, customized task prompts via text message and feedback, leveraging social connections, and use of a gamification design.
The pilot trial is designed to study the feasibility of a smartphone-based behavioral intervention in a two groups of participants diagnosed with chronic kidney disease (CKD), diabetes, and hypertension. The patients will be identified for eligibility by screening the scheduled for follow up appointments in the Penn renal CKD clinics. Patients will be prospectively enrolled after informed consent. Participants will be prospectively enrolled and will be randomized to participate into one of two arms.
All participants will receive text message reminders sent to prompt blood pressure self-monitoring at least 5 times per week, transmit the blood pressure readings to the secure Way to Health server via Omron Connect app. If a blood pressure reading is not received within 5 hours, another reminder will be sent. Automated text message feedback will be sent after the blood pressur reading is recorded with a tailored message regarding any further required actions based upon the BP readings obtained. Any participant with a single systolic blood pressure reading 200mmHg or two consecutive systolic blood pressure readings 180 mmHg or diastolic blood pressure readings 110 mmHg will be contacted immediately by an MD (Dr. Schrauben) for assessment (including evaluation for symptoms of hypertensive emergency) and referral to the emergency department, if indicated. Please see full text message algorithm (attached protocol). Any participant will undergo re-engagement protocol for low participation.
To further support behavior engagement, there is a gamification element to the design:
At the end of the study, each participant will be invited to participate in focus groups for additional feedback on their experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Support Person | Experimental | A support person not in the study will receive the participant's weekly blood pressure performance details and will contact them at least on a weekly basis to encourage continued blood pressure monitoring. Prior to randomization, the participant will select a preference between a support person that is close to them (e.g., friend or family member) or a support person who is provided by the study, a Peer Mentor. |
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| Social Norms | Experimental | In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support Person | Other | Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team. This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Adoption | Composite outcome determined by participant retention rate, total number of assessments performed by participants over complete study period; 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-4-Health at least one time as measured by data usage statistics. | Collected throughout study (8 weeks) |
| Feasibility: Adherence - Number of Participants Completed 70% or More Blood Pressure Measurements | Participants reported represent participants with good adherence, which was determined by 70% or more of the blood pressure assessments throughout the study period out of the recommended. | Collected throughout study (8 weeks) |
| Feasibility: Acceptability of SMART-HABITS-4-Health | Determined through satisfactory score on the System Usability Scale survey (defined as a score above 68). Survey range is 0-100, with higher scores indicating more usability and acceptability. | collected at 4 weeks |
| Feasibility: Acceptability of SMART-HABITS-4-Health | Determined by satisfactory score on the System Usability Scale (SUS) survey (defined by a score above 68). The SUS score range is 0-100, with higher scores indicating better usability and acceptability. | collected at 8 weeks |
| Feasibility: Acceptability of SMART-HABITS-4-Health | Determined by inductive qualitative analysis from semi-structured interviews with study participants after the end of the pilot study. There is no a priori set up codes or scales to assess this outcome as it is purely a qualitative outcome. | Collected within 12 weeks of study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Social Incentive Effectiveness | Mean change in baseline blood pressure (the baseline visit BP) to mean blood pressure after 8 weeks in both arms. | 8 weeks |
| CKD Knowledge | Determined by change in enrollment survey and end of study survey scores on responses regarding CKD knowledge using the 28-question Kidney Knowledge Survey (KiKS). The survey score is defined as the sum of the correct responses to each survey question divided by the total number of questions, total score range (0-1). Higher scores indicate better knowledge. |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Support Person | A support person not in the study will receive the participant's weekly blood pressure performance details and will contact them at least on a weekly basis to encourage continued blood pressure monitoring. Prior to randomization, the participant will select a preference between a support person that is close to them (e.g., friend or family member) or a support person who is provided by the study, a Peer Mentor. Support Person: Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team. This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly. |
| FG001 | Social Norms | In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information. Social Norms: Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Support Person | A support person not in the study will receive the participant's weekly blood pressure performance details and will contact them at least on a weekly basis to encourage continued blood pressure monitoring. Prior to randomization, the participant will select a preference between a support person that is close to them (e.g., friend or family member) or a support person who is provided by the study, a Peer Mentor. Support Person: Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team. This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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, total number of assessments performed by participants over complete study period; 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-4-Health at least one time as measured by data usage statistics. | Retention of randomized participants that completed 8 weeks of the study | Posted | Count of Participants | Participants | Collected throughout study (8 weeks) |
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Adverse event data collected from enrollment until end of the study (approximately 8-12 weeks).
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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 | Support Person | A support person not in the study will receive the participant's weekly blood pressure performance details and will contact them at least on a weekly basis to encourage continued blood pressure monitoring. Prior to randomization, the participant will select a preference between a support person that is close to them (e.g., friend or family member) or a support person who is provided by the study, a Peer Mentor. Support Person: Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team. This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Schrauben, Assistant Professor of Medicine and Epidemiology | University of Pennsylvania | 215-662-8730 | 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2022 | Mar 24, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Social Norms | Other | Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion. |
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| 8 weeks |
| Self-Efficacy | Determined by change in enrollment survey and end of study survey scores on responses regarding self-efficacy using the Self-Efficacy for Managing Chronic Disease 6-Item Scale. Answers range from 1 = not at all confident to 10= totally confident. Total summary score range is 6-60, with higher summary scores indicating higher self-efficacy. | 8 weeks |
| Chronic Disease Self-Management | Determined by change in enrollment survey and end of study survey scores on responses regarding self-management using the Partners in Health Scale for Chronic Condition Self-Management (11 items). Answers range from 0=very good to 8= very poor for each of the 11 items. Total summary score range is 0-88, with higher summary scores indicating better self-management. | 8 weeks |
| Disease Related Quality of Life Change Scores | Change from baseline to end of study in disease-specific quality of life as measured by the Kidney Disease and Quality of Life 36-item survey (KDQOL-36), a validated instrument assessing health-related quality of life in individuals with kidney disease. The KDQOL-36 includes kidney disease-specific sub scales: Burden of Kidney Disease, Symptoms and Problems, and Effects of Kidney disease on Daily Life. Raw scores are transformed to T-scores, standardized to a general population reference with a mean of 50 and standard deviation of 10. For all sub-scales, higher T-scores indicate better health-related quality of life (i.e., lower symptom burden and less impact of kidney disease), while lower scores indicate worse quality of life. Scores are reported separately by each domain. A change of approximately 5 points is generally considered clinically meaningful in kidney disease populations. | 8 weeks |
| Maintenance | Determined by the usage of SMART-HABITS-4-Health. Good maintenance will be determined by at least one access to the SMART-HABITS-4-Health portal or one BP monitor each week. | 8 weeks |
| Reach | Determined by the comparison of the sex frequency (percentage) of the enrolled participants compared to sex frequency of general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 54% female and 46% male). | 8 weeks |
| Reach | Determined by the comparison of race groups (Black, White Asian, other) frequency (percentage) of the enrolled participants compared to the race frequencies of the general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 20% for Black, 12% White, 14% Asian, and 14% Hispanic). | 8 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 collected with field notes from verbal conversations and textual data from email and text messages. | 8 weeks |
| BG001 | Social Norms | In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information. Social Norms: Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| OG001 | Social Norms | In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information. Social Norms: Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion. |
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| Primary | Feasibility: Adherence - Number of Participants Completed 70% or More Blood Pressure Measurements | Participants reported represent participants with good adherence, which was determined by 70% or more of the blood pressure assessments throughout the study period out of the recommended. | Randomized participants who were not withdrawn who sent in blood pressure measures at least 5 times per week throughout the 8 week study. | Posted | Count of Participants | Participants | Collected throughout study (8 weeks) |
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| Primary | Feasibility: Acceptability of SMART-HABITS-4-Health | Determined through satisfactory score on the System Usability Scale survey (defined as a score above 68). Survey range is 0-100, with higher scores indicating more usability and acceptability. | Number of participants who completed the usability survey at 4 weeks. | Posted | Mean | Standard Deviation | score on a scale | collected at 4 weeks |
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| Primary | Feasibility: Acceptability of SMART-HABITS-4-Health | Determined by satisfactory score on the System Usability Scale (SUS) survey (defined by a score above 68). The SUS score range is 0-100, with higher scores indicating better usability and acceptability. | Number of participants who completed system usability scale at 8 weeks. | Posted | Mean | Standard Deviation | score on a scale | collected at 8 weeks |
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| Primary | Feasibility: Acceptability of SMART-HABITS-4-Health | Determined by inductive qualitative analysis from semi-structured interviews with study participants after the end of the pilot study. There is no a priori set up codes or scales to assess this outcome as it is purely a qualitative outcome. | Participants who participants in the optional one-on-one semi structured interview or focus group. | Posted | Count of Participants | Participants | Collected within 12 weeks of study completion |
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| Secondary | Social Incentive Effectiveness | Mean change in baseline blood pressure (the baseline visit BP) to mean blood pressure after 8 weeks in both arms. | Number of participants included in study at 8 weeks. | Posted | Mean | Standard Deviation | mean difference of systolic BP (mmHg) | 8 weeks |
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| Secondary | CKD Knowledge | Determined by change in enrollment survey and end of study survey scores on responses regarding CKD knowledge using the 28-question Kidney Knowledge Survey (KiKS). The survey score is defined as the sum of the correct responses to each survey question divided by the total number of questions, total score range (0-1). Higher scores indicate better knowledge. | Number of participants who completed the KiKS survey at 8 weeks. | Posted | Mean | Standard Deviation | mean change of score on a scale | 8 weeks |
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| Secondary | Self-Efficacy | Determined by change in enrollment survey and end of study survey scores on responses regarding self-efficacy using the Self-Efficacy for Managing Chronic Disease 6-Item Scale. Answers range from 1 = not at all confident to 10= totally confident. Total summary score range is 6-60, with higher summary scores indicating higher self-efficacy. | Number of participants who completed self-efficacy survey at end of study. | Posted | Mean | Standard Deviation | Mean change in score on a scale | 8 weeks |
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| Secondary | Chronic Disease Self-Management | Determined by change in enrollment survey and end of study survey scores on responses regarding self-management using the Partners in Health Scale for Chronic Condition Self-Management (11 items). Answers range from 0=very good to 8= very poor for each of the 11 items. Total summary score range is 0-88, with higher summary scores indicating better self-management. | Number of participants who completed self-management questionnaire at 8 weeks. | Posted | Mean | Standard Deviation | Mean change of score on scale | 8 weeks |
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| Secondary | Disease Related Quality of Life Change Scores | Change from baseline to end of study in disease-specific quality of life as measured by the Kidney Disease and Quality of Life 36-item survey (KDQOL-36), a validated instrument assessing health-related quality of life in individuals with kidney disease. The KDQOL-36 includes kidney disease-specific sub scales: Burden of Kidney Disease, Symptoms and Problems, and Effects of Kidney disease on Daily Life. Raw scores are transformed to T-scores, standardized to a general population reference with a mean of 50 and standard deviation of 10. For all sub-scales, higher T-scores indicate better health-related quality of life (i.e., lower symptom burden and less impact of kidney disease), while lower scores indicate worse quality of life. Scores are reported separately by each domain. A change of approximately 5 points is generally considered clinically meaningful in kidney disease populations. | Number of participants who completed the KDQOL-36 survey at 8 weeks. | Posted | Mean | Standard Deviation | Change of the T-score (mean change, SD) | 8 weeks |
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| Secondary | Maintenance | Determined by the usage of SMART-HABITS-4-Health. Good maintenance will be determined by at least one access to the SMART-HABITS-4-Health portal or one BP monitor each week. | Number of participants randomized | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Reach | Determined by the comparison of the sex frequency (percentage) of the enrolled participants compared to sex frequency of general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 54% female and 46% male). | Number of participants randomized. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Reach | Determined by the comparison of race groups (Black, White Asian, other) frequency (percentage) of the enrolled participants compared to the race frequencies of the general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 20% for Black, 12% White, 14% Asian, and 14% Hispanic). | Randomized participants | Posted | Count of Participants | Participants | 8 weeks |
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| 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 collected with field notes from verbal conversations and textual data from email and text messages. | Posted | Count of Participants | Participants | No | 8 weeks |
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|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Social Norms | In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information. Social Norms: Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion. | 0 | 37 | 0 | 37 | 0 | 37 |
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| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Theme: Program Barriers |
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| Theme: Feedback on technology |
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| Theme: Suggestions for Improvement |
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| Effects of Kidney Disease on Daily Life |
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| White race group |
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| Active Assistance with Synchronization of Technology |
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| Videoconference/in-person Meeting for Technology Issues |
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| Collection of Blood Pressure Device for Data Collection |
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| Switched Virtual to Physical ClinCards |
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| Interview Collection of Enrollment Survey Instead of Self-Report |
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