Renal Insufficiency, ChronicSMART-HABITSNCT04858295

Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease

A study testing Texting and mHealth app in people with Renal Insufficiency, Chronic and Hypertension, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Insufficiency, Chronic, Hypertension
What is being tested?: Texting and mHealth app
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2021to 1 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Renal Insufficiency, Chronic, Hypertension
Being tested: Texting, mHealth app
Medical subject headings: Renal Insufficiency, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TextingDevice
Also called Way to Health, SMS Text
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.
mHealth appDevice
Also called Omron Connect, Smartphone application
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.

Study groups in NCT04858295
Study group	Role	What they receive
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. Receives: Device: Texting
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. Receives: Device: mHealth app

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 12 weeks
Effectiveness of Home Monitoring of BP
Mean systolic blood pressure after 4, 8, and 12 weeks
Measured: 4, 8, and 12 weeks
Effectiveness of Step Monitoring
Mean step count in first week, and after 4, 8, and 12 weeks.
Measured: 4, 8, and 12 weeks
Maintenance
Determined by transmitting at least one BP monitored reading or daily step count each week.
Measured: 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.
Measured: 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%)
Measured: 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%)
Measured: 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%).
Measured: Enrolled and randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 20211 May 2023

First posted26 Apr 2021
Study start26 Jul 2021
Primary completion30 Jun 2022
Study completion1 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04858295
Sponsor's protocol ID: 832097
Other IDs: K23DK118198-03
Acronym: SMART-HABITS
Status last verified: Oct 2025
First submitted: 31 Mar 2021
Last updated: 17 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: To be determined

Publications

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.
PubMed 38954482

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial of the Feasibility of a Patient-Centered Mobile Health Self-Management Support Tool for Healthy Behaviors (SMART-HABITS) in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT04858295
Acronym / sponsor ID: SMART-HABITS / 832097
Conditions: Renal Insufficiency, Chronic, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 26 Jul 2021 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 1 May 2023 (actual)
First posted: 26 Apr 2021 (actual)
Results: Posted 9 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Texting Arm	Active comparator	Device: TextingParticipants 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	Device: mHealth appParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TextingAlso: Way to Health, SMS TextThe 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.	Device	Texting Arm
mHealth appAlso: Omron Connect, Smartphone applicationOmron 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.	Device	mHealth app Arm

Primary outcome

Feasibility: Adoption
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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).

12 secondary outcomes

Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time frame: 12 weeks
Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time frame: 12 weeks
Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time frame: 12 weeks
Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time frame: 12 weeks
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Time frame: 12 weeks
Effectiveness of Home Monitoring of BP
Time frame: 4, 8, and 12 weeks
Effectiveness of Step Monitoring
Time frame: 4, 8, and 12 weeks
Maintenance
Time frame: 12 weeks
Implementation Issues
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Enrolled and randomized

Results and safety

Results posted to the registry on 9 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Text Message and Then mHealth App Arm	23	22
mHealth App Then Texting Arm	24	21

Primary outcome: Feasibility: Adoption

Time frame: Collected throughout study (12 weeks). Count of participants. Unit: Participants

Measure	Per Intervention: Text Message n = 47	Per Intervention: mHealth App n = 47
Retention	44	42
Any use of SMART-HABITS	18	22

Population analysed: Participants randomized to intervention sequence.

Primary outcome: Feasibility: Adherence

Time frame: Collected throughout study (12 weeks). Count of participants. Unit: Participants

Measure	Texting Arm n = 47	mHealth App Arm n = 47
Adherence to 3 or more BP transmissions per week	36	30
Adherence to 5 or more daily step count transmissions per week	43	43

Population analysed: Participants receiving intervention

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

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	All Study Participants n = 42
Value	12 (10 to 14)

Population analysed: 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.

Primary outcome: Feasibility: Acceptability of SMART-HABITS

Time frame: 4 weeks, 8 weeks, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Text Message First (at 4 Weeks) n = 23	mHealth App (at 4 Weeks) n = 24	Text Message Then mHealth App (at 8 Weeks) n = 23	mHealth App Then to Text Message (at 8 Weeks) n = 16	12 Week Usability Survey of Those Who Received Text Message Arm First n = 23	12 Week Usability Survey of Those Two Received mHealth Arm First n = 24
Value	77 (16.2)	64.5 (19.7)	70.1 (14.8)	65.9 (19.4)	71.6 (16.4)	65.6 (21.7)

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

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the entire study duration (12 weeks) for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Texting Arm	0 of 47 (0%)	0 of 47 (0%)	0 of 47
mHealth App Arm	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38954482Schrauben 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.
Individual participant dataSharing planned: Undecided. To be determined

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Schrauben, MD, MSCE principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Texting and mHealth app in people with Renal Insufficiency, Chronic and Hypertension, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Adoption (time frame: Collected throughout study (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04858295, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.