Text Message Reminders & Social Support for Chronic Diseases

Overseen By Sarah Schrauben, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called SMART-HABITS for Health, which uses text messages for motivational support to help individuals with chronic kidney disease, hypertension (high blood pressure), and diabetes manage their health. Participants will receive text reminders to check their blood pressure and access social support from either a chosen person or a study mentor. Some participants will also track their progress compared to others through a leaderboard. This trial suits individuals who have one of these conditions, visit the University of Pennsylvania nephrology practice, and own a smartphone or tablet. As an unphased trial, this study offers a unique opportunity to contribute to innovative health management strategies.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the focus is on text message reminders and support.

What prior data suggests that this protocol is safe for patients with chronic diseases?

Research shows that using a smartphone tool like SMART-HABITS for Health is practical for people with chronic kidney disease and high blood pressure. It helps them manage their health by sending motivational text reminders. Studies have found that people use this tool without major problems.

SMART-HABITS encourages self-care by helping users set health goals and connect with others for support. No reports of serious side effects have emerged from using this tool, suggesting it is safe and well-tolerated.

Overall, evidence indicates that SMART-HABITS is a safe option to help manage chronic conditions like high blood pressure and diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the SMART-HABITS for Health protocol because it introduces innovative ways to manage chronic diseases like hypertension. Unlike traditional methods that often rely solely on medication and occasional doctor visits, this approach leverages the power of social support and digital technology. The "Support Person" arm provides participants with a personal touch by involving someone close to them or a peer mentor to encourage regular blood pressure monitoring. Meanwhile, the "Social Norms" arm uses text messages to keep participants informed about how their health stats stack up against others, adding a competitive edge with a leaderboard. These elements aim to enhance motivation and accountability, potentially leading to better health outcomes.

What evidence suggests that SMART-HABITS for Health could be effective for managing chronic kidney disease, hypertension, and diabetes?

Research shows that the SMART-HABITS for Health program helps people with chronic kidney disease (CKD) and high blood pressure manage their health more effectively. Studies have found that patients find using a smartphone tool like SMART-HABITS easy and enjoyable. This trial will evaluate two different approaches within the SMART-HABITS program. In one arm, participants will have a support person who receives their weekly blood pressure performance details and provides encouragement. In another arm, participants will receive texted reports of blood pressure performance statistics of other participants and weekly feedback on how their information compares. Early results suggest that participants find the reminders and social support useful for tracking their health. Overall, the program aims to simplify managing chronic conditions through technology and social connections. ^{1 5 6 7 8}

Who Is on the Research Team?

Sarah Schrauben, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Own a smart device (smartphone or tablet) capable of connecting to the internet and has Bluetooth enabled technology

I have chronic kidney disease, high blood pressure, or diabetes.

Able and willing to provide informed consent

Exclusion Criteria

You live in a long-term care or rehabilitation facility.

Planning to travel or live consecutively out of the country for more than one month

Already participating in another blood pressure study or intervention trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a smartphone-based behavioral intervention with social incentives and gamification for blood pressure monitoring

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including focus groups for feedback

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SMART-HABITS for Health

Trial Overview

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.

How Is the Trial Designed?

Group I: Support Person Experimental Treatment 1 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 Norms Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Wellness Diary (WD) mobile application is designed to help users track and change their behaviors to manage chronic conditions, and it has been found acceptable and useful for long-term use.

However, WD currently lacks engaging features to ensure users remain motivated and committed over time, highlighting the need for improvements in personalization and feedback to enhance user experience and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering citizens for well-being and chronic disease management with wellness diary. Mattila, E., Korhonen, I., Salminen, JH., et al.[2018]

A pilot study involving 47 adults with diabetes showed that using text messaging to prompt blood sugar readings significantly increased patient engagement, with 66% of participants providing glucose readings when prompted, compared to only 12% at previous visits.

Participants reported feeling more accountable and supported in managing their diabetes, indicating that text messaging can enhance communication and self-management behaviors between clinic visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care by cell phone: text messaging for chronic disease management. Fischer, HH., Moore, SL., Ginosar, D., et al.[2022]

The BeWell24 app, designed to promote healthy lifestyle behaviors related to sleep, sedentary time, and exercise, was tested over 8 weeks with 26 participants, showing that users logged about 60% of their behaviors.

While the app was effective in engaging users with sleep and sedentary components, exercise tracking had low usage, and overall user satisfaction was only modest, indicating areas for improvement in user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BeWell24: development and process evaluation of a smartphone "app" to improve sleep, sedentary, and active behaviors in US Veterans with increased metabolic risk. Buman, MP., Epstein, DR., Gutierrez, M., et al.[2020]

A new trial is testing the effectiveness of SMS text messages designed to improve medication adherence in adults with type 2 diabetes, involving 958 participants over 12 months, aiming to reduce cardiovascular risk.

Preliminary feasibility studies indicate that these SMS messages are acceptable to patients and successfully influence medication adherence, setting the stage for this larger trial to assess their impact compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. Farmer, A., Jones, L., Newhouse, N., et al.[2023]

The NutriWalking (NW) app was developed to help individuals with type 2 Diabetes Mellitus and Depression by providing personalized exercise goals and promoting healthy eating habits within small peer teams.

Early usability and acceptability studies suggest that NW could be an effective self-management support tool, highlighting the importance of technology in encouraging health behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a team-based mobile health (mHealth) application for lifestyle self-management in individuals with chronic illnesses. Hartzler, AL., Venkatakrishnan, A., Mohan, S., et al.[2020]

Health reminders are crucial for helping patients manage chronic illnesses, but many face challenges like lack of motivation and ability to act on these reminders, leading to negative health outcomes.

Through participatory design sessions with mothers of children with asthma and older adults with type 2 diabetes, four types of persuasive health reminders were identified: introspective, socially supportive, adaptive, and symbolic, highlighting the need for features that enhance understanding and collaboration in health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persuasive Reminders for Health Self-Management. O'Leary, K., Liu, L., McClure, JB., et al.[2018]

The 'My Kidneys & Me' program is a 10-week digital self-management intervention designed to improve patient activation in individuals with chronic kidney disease (CKD) stages 3-4, with a total of 432 participants planned for the study.

The study will assess the feasibility of the intervention and its impact on patient activation levels using the Patient Activation Measure (PAM-13), with outcomes evaluated at baseline, 10 weeks, and 20 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Self-Management Intervention through Lifestyle Education for Kidney health' (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. Lightfoot, CJ., Wilkinson, TJ., Yates, T., et al.[2022]

Text messaging can be an effective tool to improve medication refill behavior among patients with chronic conditions, as it can be easily delivered at scale and tailored to individual needs.

Patients preferred personalized, positively framed messages that evoke social support, suggesting that the design of these messages is crucial for enhancing medication adherence and improving chronic care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews. Waughtal, J., Luong, P., Sandy, L., et al.[2022]

Patients using self-management digital interventions (DIs) for chronic conditions like hypertension and asthma reported feeling more reassured and engaged in their health management, leading to more meaningful consultations with healthcare professionals (HCPs).

Healthcare professionals noted improved clinical control and appreciated patients' enhanced understanding of their conditions, indicating that DIs can effectively support both patient self-management and HCP oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. Morton, K., Dennison, L., May, C., et al.[2022]

Out of 1,749 diabetes-related apps, only 156 were suitable for analysis, generating 473 feedback messages primarily focused on blood sugar measurement, highlighting a gap in comprehensive support for Healthy Coping behaviors.

Most feedback messages did not align with the behavioral change theory framework, indicating a need for better-structured messages to effectively promote behavior change in diabetes self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Healthy Coping Feedback Messages from Diabetes Mobile Apps: Validation Against an Evidence-Based Framework. Narindrarangkura, P., Ye, Q., Boren, SA., et al.[2023]

Text message reminders (TMR) significantly improved medication adherence among 1678 patients with coronary heart disease, showing a 2.85 times greater adherence rate compared to the control group.

TMR also led to notable reductions in systolic blood pressure and cholesterol levels, contributing to better clinical outcomes, although it did not affect mortality or diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. Zhao, YY., Dang, FP., Zhai, TT., et al.[2022]

A review of 33 North American clinical trials on mHealth interventions for chronic illness revealed that most studies (30 out of 33) effectively supported self-care maintenance behaviors, but fewer focused on self-care monitoring (12 trials) and self-care management (8 trials).

The analysis highlighted a significant gap in the examination of diverse self-care behaviors, with an overemphasis on physical activity and diet, suggesting the need for more comprehensive studies that address a wider range of self-care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review and theoretical examination of chronic illness mHealth studies using the Middle-Range Theory of Self-care of Chronic Illness. Buck, HG., Shadmi, E., Topaz, M., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38954482/

Supporting Self-Management of Healthy Behaviors in Chronic ...

Conclusions: Implementing a smartphone support tool for self-management was feasible among people with CKD and hypertension. The approach can ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05565716

Supporting Self-Management of Healthy Behaviors in ...

The planned intervention, entitled, Supporting Self-Management of Health Behaviors to Optimize Health (SMART-HABITS for Health), aims to provide support for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11390029/

The Supporting Self-Management of Healthy Behaviors ...

SMART-HABITS, one of the first smartphone-based self-management programs to support people with CKD and hypertension, promoted self-monitoring of BP and ...

4.

journals.lww.com

journals.lww.com/jasn/fulltext/2023/11001/supporting_self_management_of_healthy_behaviors.143.aspx

Supporting Self-Management of Healthy Behaviors ...

In a 12-week study among individuals with stage 3-4 CKD and HTN, we evaluated the acceptance and feasibility of SMART-HABITS, a smartphone-based intervention to ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04858295

Supporting Self-Management of Healthy Behaviors in ...

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.

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05565716/supporting-self-management-of-healthy-behaviors-in-diabetes-kidney-disease-and-hypertension

Supporting Self-Management of Healthy Behaviors in ...

The planned intervention, entitled, Supporting Self-Management of Health Behaviors to Optimize Health (SMART-HABITS for Health), aims to ...

7.

withpower.com

withpower.com/trial/phase-renal-insufficiency-10-2022-12719

Text Message Reminders & Social Support for Chronic ...

Trial Overview The SMART-HABITS for Health intervention supports self-management in patients with kidney disease, high blood pressure, and diabetes. It uses ...

8.

researchgate.net

researchgate.net/publication/381923192_Supporting_Self-Management_of_Healthy_Behaviors_in_Chronic_Kidney_Disease_and_Hypertension_The_SMART-HABITS_Pilot_Randomized_Trial

Supporting Self-Management of Healthy Behaviors in ...

Methods SMART-HABITS was piloted in a 12-week randomized cross-over trial among people with CKD and hypertension. Participants were asked to monitor blood ...