Trial Summary
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.
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.
12345What 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.
45678Is 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.
89101112Eligibility 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
+4 more
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
+6 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn Presbyterian Medical CenterPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. [2022]To understand the experiences of patients and healthcare professionals (HCPs) using self-management digital interventions (DIs) for chronic physical health conditions.
Analysis of Healthy Coping Feedback Messages from Diabetes Mobile Apps: Validation Against an Evidence-Based Framework. [2023]Label="BACKGROUND">In this study, we focused on Healthy Coping, a key principle of ADCES7 Self-Care Behaviors® (ADCES7®) that enables people with diabetes to achieve health goals for self-care. We aimed to validate Healthy Coping-related feedback messages from diabetes mobile apps against the framework based on behavioral change theories.
An integrative review and theoretical examination of chronic illness mHealth studies using the Middle-Range Theory of Self-care of Chronic Illness. [2021]Self-management, or self-care, by individuals and/or families is a critical element in chronic illness management as more care shifts to the home setting. Mobile device-enhanced health care, or mHealth, is being touted as a means to support self-care. Previous mHealth reviews examined the effect of mHealth on patient outcomes, however, none used a theoretical lens to examine the interventions themselves. The aims of this integrative review were to examine recent (e.g., last 10 years) chronic illness mHealth empiric studies and (1) categorize self-care behaviors engaged in the intervention according to the Middle-Range Theory of Self-care of Chronic Illness, and (2) conduct an analysis of gaps in self-care theory domains and behaviors utilized. Methods included: (1) Best practice study identification, collection, and data extraction procedures and (2) realist synthesis techniques for within and across case analysis. From a pool of 652 records, 33 primarily North American clinical trials, published between 2010 and 2019 were examined. Most mHealth interventions used apps, clinician contact, and behavioral prompts with some wireless devices. Examination found self-care maintenance behaviors were supported in most (n = 30) trials whereas self-care monitoring (n = 12) and self-care management behaviors (n = 8) were less so. Few trials (n = 2) targeted all three domains. Investigation of specific behaviors uncovered an overexamination of physical activity and diet behaviors and an underexamination of equally important behaviors. By examining chronic illness mHealth interventions using a theoretical lens we have categorized current interventions, conducted a gap analysis uncovering areas for future study, and made recommendations to move the science forward.
The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. [2022]To determine the effectiveness of text message reminders (TMR) on medication adherence (MA) and to investigate the effects of TMR on clinical outcomes.
'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]Many people living with chronic kidney disease (CKD) are expected to self-manage their condition. Patient activation is the term given to describe the knowledge, skills and confidence a person has in managing their own health and is closely related to the engagement in preventive health behaviours. Self-management interventions have the potential to improve remote disease management and health outcomes. We are testing an evidence-based and theory-based digital self-management structured 10-week programme developed for peoples with CKD called 'My Kidneys & Me'. The primary aim of the study (Self-Management Intervention through Lifestyle Education for Kidney health (SMILE-K)) is to assess the effect on patient activation levels.
Empowering citizens for well-being and chronic disease management with wellness diary. [2018]Chronic conditions closely related to lifestyles are the major cause of disability and death in the developed world. Behavior change is the key to managing well-being and preventing and managing chronic diseases. Wellness diary (WD) is a mobile application designed to support citizens in learning about their behavior, and both making and maintaining behavior changes. WD has been found acceptable, useful, and suitable for long-term use as a part of an intervention. When used independently, however, it does not seem to have enough engaging and motivating features to support adoption and long-term commitment. The main improvement needs identified based on a review of WD-related studies were: personalization of the application to individual needs, increasing motivation during early use, maintaining motivation, and aiding in relapse recovery in long-term use. We present concepts to improve the personalization of WD as well as improvements to the feedback and interpretation of the self-observation data. We also present usage models on how this type of mobile application could be utilized.
BeWell24: development and process evaluation of a smartphone "app" to improve sleep, sedentary, and active behaviors in US Veterans with increased metabolic risk. [2020]Lifestyle behaviors across the 24-h spectrum (i.e., sleep, sedentary, and active behaviors) drive metabolic risk. We describe the development and process evaluation of BeWell24, a multicomponent smartphone application (or "app") that targets behavior change in these interdependent behaviors. A community-embedded iterative design framework was used to develop the app. An 8-week multiphase optimization strategy design study was used to test the initial efficacy of the sleep, sedentary, and exercise components of the app. Process evaluation outcomes included objectively measured app usage statistics (e.g., minutes of usage, self-monitoring patterns), user experience interviews, and satisfaction ratings. Participants (N = 26) logged approximately 60 % of their sleep, sedentary, and exercise behaviors, which took 3-4 min/day to complete. Usage of the sleep and sedentary components peaked at week 2 and remained high throughout the intervention. Exercise component use was low. User experiences were mixed, and overall satisfaction was modest.
Persuasive Reminders for Health Self-Management. [2018]Health reminders are integral to self-managing chronic illness. However, to act on these health reminders, patients face many challenges, such as lack of motivation and ability to perform health tasks. As a result, patients experience negative consequences for their health. To investigate the design of health reminders that persuade patients to take action, we conducted six participatory design sessions with two cohorts: mothers of children with asthma, and older adults with type 2 diabetes. Participants used collages, storyboards, and photos to express design ideas for future health reminder systems. From their design artifacts, we identified four types of persuasive reminders for health self-management: introspective, socially supportive, adaptive, and symbolic. We contribute insights into desired features for persuasive reminder systems from the perspectives of patients and informal caregivers, including features that support users to understand why and how to complete health tasks ahead of time, and affordances for intra-familial and patient-provider collaboration.
Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews. [2022]Almost 50% of patients with cardiovascular diseases face challenges in taking medications and increased morbidity and mortality. Text messaging may impact medication refill behavior and can be delivered at scale to patients by texting mobile phones. To obtain feedback from persons with chronic conditions on the design of interactive text messages and determine language of message for making messages that can motivate patients to refill medications on time. We purposively sampled 35 English and Spanish speaking patients with at least one chronic condition from three large healthcare delivery systems to participate in N-of-1 video-based synchronous interviews. Research assistants shared ideas for theory-informed text messages with content intended to persuade patients to refill their medication. We transcribed recorded interviews and conducted a content analysis to identify strategies to employ generating a dynamic interactive text message library intended to increase medication refill. Those interviewed were of diverse age and race/ethnicity and typical of persons with multiple chronic conditions. Several participants emphasized that personally tailored and positively framed messages would be more persuasive than generic and/or negative messages. Some patients appreciated humor and messages that could evoke a sense of social support from their providers and rejected the use of emojis. Messages to remind patients to refill medications may facilitate improvements in adherence, which in turn can improve chronic care. Designing messages that are persuasive and can prompt action is feasible and should be considered given the ease with which such messages can be delivered automatically at scale.
Acceptability of a team-based mobile health (mHealth) application for lifestyle self-management in individuals with chronic illnesses. [2020]With increased incidence of chronic illnesses arising due to unhealthy lifestyle habits, it is increasingly important to leverage technology applications to promote and sustain health behavior change. We developed a smartphone-based application, NutriWalking (NW), which recommends personalized daily exercise goals and promotes healthy nutritional habits in small peer teams. Here, we demonstrate an early study of usability and acceptability of this app in patients with type 2 Diabetes Mellitus and Depression. Our goal was to evaluate the potential of NW as a self-management support tool. Findings point to design considerations for team-based self-management tools delivered via mHealth platforms.
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]Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial.
Care by cell phone: text messaging for chronic disease management. [2022]To assess the feasibility of engaging adults with diabetes in self management behaviors between clinic visits by using cell phone text messaging to provide blood sugar measurement prompts and appointment reminders.