Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension (NCT05565716) | Clinical Trial Compass
CompletedNot Applicable
Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension
United States73 participantsStarted 2023-08-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of chronic kidney disease (any stage), hypertension, diabetes
* followed at University of Pennsylvania nephrology practice
* aged 18 years or over. -
* own a smart device (smartphone or tablet) capable of connecting to the internet and has Bluetooth enabled technology
* able to comprehend English.
* a mean blood pressure reading of \<180/100 mmHg in person study visit
* able and willing to provide informed consent
Exclusion Criteria:
* inability to provide consent or read or speak English
* inability to self-monitor (e.g., diagnosis of dementia, cognitive impairment, physically unable to set up BP cuff and machine)
* already participating in another blood pressure study or intervention trial
* vulnerable populations, living in a long-term care or rehabilitation institution,
* if 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
* mean blood pressure reading of \>180/100 mmHg at in person study visit
* hypertension not managed by the nephrologist in Penn Medicine
* any other reason they do not expect to be able to complete the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: Adoption
Timeframe: Collected throughout study (8 weeks)
2
Feasibility: Adherence - Number of Participants Completed 70% or More Blood Pressure Measurements
Timeframe: Collected throughout study (8 weeks)
3
Feasibility: Acceptability of SMART-HABITS-4-Health
Timeframe: collected at 4 weeks
4
Feasibility: Acceptability of SMART-HABITS-4-Health
Timeframe: collected at 8 weeks
5
Feasibility: Acceptability of SMART-HABITS-4-Health
Timeframe: Collected within 12 weeks of study completion