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Texting Arm for Chronic Kidney Disease (SMART-HABITS Trial)

N/A
Waitlist Available
Led By Sarah Schrauben, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8, and 12 weeks
Awards & highlights

SMART-HABITS Trial Summary

This trial is testing a smartphone app designed to help people with chronic kidney disease and hypertension manage their condition. The app provides reminders, feedback, and educational resources. The trial is using a cross-over design to test preferences for text message or app-based communication of blood pressure readings.

Eligible Conditions
  • Chronic Kidney Disease
  • High Blood Pressure

SMART-HABITS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8, and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility: Acceptability of SMART-HABITS
Feasibility: Adherence
Feasibility: Adoption
+1 more
Secondary outcome measures
Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
+9 more

SMART-HABITS Trial Design

2Treatment groups
Active Control
Group I: Texting ArmActive Control1 Intervention
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.
Group II: mHealth app ArmActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,041 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,194 Total Patients Enrolled
Sarah Schrauben, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experiment still available?

"As per details on clinicaltrials.gov, this medical trial is no longer enrolling candidates; the original posting was made on July 26th 2021 and last updated August 11th 2022. Thankfully, there are 1,317 alternate trials that are actively searching for participants at present."

Answered by AI

What outcomes is this research aiming to accomplish?

"The primary measure of success for this trial, which is scheduled to last approximately 12 weeks, will be the Adherence rate. Secondary outcomes include Improvement in Quality of Life (measured by Kidney Disease and Quality of Life 36-item survey), Effectiveness of Blood Pressure Monitoring (determined by comparison between baseline reading and subsequent readings after 4, 8 and 12 weeks) as well as Reach (defined through a comparison between ethnicity frequency among enrolled participants versus that within similar population groups)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease
2021. "Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04858295.
~13 spots leftby Apr 2025
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