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

70 Participants Needed

Trial Summary

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 data supports the idea that Text Message Reminders & Social Support for Chronic Diseases is an effective treatment?

The available research shows that text message reminders can improve medication adherence, which means patients are more likely to take their medicine as prescribed. This is important for managing chronic diseases like diabetes, kidney disease, and hypertension. Additionally, self-management interventions, which include digital tools like text messages, have been shown to help patients better manage their health by increasing their knowledge, skills, and confidence. This can lead to better health outcomes compared to not using these digital interventions. ^{1 2 3 4 5}

What safety data exists for text message reminders and social support in managing chronic diseases?

The provided research does not directly address safety data for text message reminders and social support interventions like SMART-HABITS. However, related studies suggest that mobile applications and digital interventions for chronic disease management are generally found to be acceptable and useful. The studies focus on user engagement, satisfaction, and the effectiveness of behavior change, but do not specifically mention safety concerns. Therefore, while these interventions are considered suitable for long-term use, specific safety data is not detailed in the provided research. ^{4 5 6 7 8}

Is the treatment SMART-HABITS for Health a promising treatment for chronic diseases?

Yes, SMART-HABITS for Health is a promising treatment for chronic diseases. It uses text message reminders and social support to help people manage their health better. This approach can motivate patients to take their medications on time and stay on top of their health tasks, which can lead to better health outcomes. ^{8 9 10 11 12}

What is the purpose of this trial?

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, 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.

Research Team

Sarah Schrauben, MD, MSCE

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Analysis of Healthy Coping Feedback Messages from Diabetes Mobile Apps: Validation Against an Evidence-Based Framework. [2023]

3. United States 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. [2021]

4. United States 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. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Empowering citizens for well-being and chronic disease management with wellness diary. [2018]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Persuasive Reminders for Health Self-Management. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acceptability of a team-based mobile health (mHealth) application for lifestyle self-management in individuals with chronic illnesses. [2020]

11. Canada 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Care by cell phone: text messaging for chronic disease management. [2022]