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Text Message Reminders & Social Support for Chronic Diseases
N/A
Recruiting
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
Diagnosis of chronic kidney disease (any stage), hypertension, diabetes
Aged 18 years or over
Must not have
Inability to self-monitor (e.g., diagnosis of dementia, cognitive impairment, physically unable to set up BP cuff and machine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected with 12 weeks of study completion
Awards & highlights
No Placebo-Only Group
Summary
This trial supports patients with chronic diseases by providing text message reminders & support to help track & manage blood pressure, leveraging social connections & gamification.
Who is the study for?
This trial is for adults over 18 with chronic kidney disease, hypertension, or diabetes who are patients at the University of Pennsylvania nephrology practice. They must have a blood pressure lower than 180/100 mmHg, own a smart device with internet and Bluetooth, understand English, and be able to give informed consent.
What is being tested?
The SMART-HABITS for Health intervention supports self-management in patients with kidney disease, high blood pressure, and diabetes. It uses motivational text messages, goal setting prompts via texts leveraging social connections and gamification to encourage regular blood pressure monitoring.
What are the potential side effects?
Since this trial involves behavioral interventions like text message reminders rather than medications or medical procedures, there are no direct physical side effects. However participants may experience stress or anxiety related to self-monitoring or changes in behavior.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic kidney disease, high blood pressure, or diabetes.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot monitor my health by myself due to a condition like dementia or physical limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected with 12 weeks of study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected with 12 weeks of study completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility: Acceptability of SMART-HABITS-4-Health
Feasibility: Adherence
Feasibility: Adoption
Secondary study objectives
Chronic Kidney Diseases
Chronic disease
Disease Related Quality of Life
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Support PersonExperimental Treatment1 Intervention
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.
Group II: Social NormsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,561 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,359 Total Patients Enrolled
Sarah Schrauben, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
147 Total Patients Enrolled
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