Text Messaging for Heart Failure

(TEXT4HF Trial)

Overseen By Jonathan W Leigh, MPH, MSHI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Loop diuretics

Disqualifiers: Heart transplant, Psychosis, Advanced renal disease, others

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

Compensation: Varies

Number of Visits: 8

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tailored text messages can help older adults with heart failure improve their self-care. Participants will receive either regular care or regular care plus approximately five text messages a week, encouraging healthy habits such as taking medications, eating well, and self-monitoring. The study seeks individuals diagnosed with heart failure, taking specific heart medications, possessing a mobile phone with texting capabilities, and feeling the need to improve their self-care.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance self-care strategies for heart failure patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems like you will continue with your usual care, which includes your regular medications.

What prior data suggests that this text messaging intervention is safe for older adults with heart failure?

Research has shown that text messaging programs like TEXT4HF are generally safe and easy to use. In past studies, people with heart failure who received personalized text messages to help manage their condition reported no major problems. These studies found that older adults consider these programs both doable and acceptable, with no significant reports of negative effects from receiving the messages.

The messages aim to assist with medication adherence, encourage a heart-healthy diet, and support self-monitoring of health. This method has improved self-care without introducing new health risks. Overall, using text messages in health programs maintains a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TEXT4HF because it leverages the power of technology to enhance heart failure care. Unlike traditional treatments that focus on medications and lifestyle changes through in-person consultations, TEXT4HF uses tailored text messages to reinforce key health behaviors like medication adherence, heart-healthy eating, and self-monitoring. This method is innovative because it provides continuous, personalized support and education directly to patients' phones, potentially increasing engagement and improving outcomes without the need for frequent clinic visits. By integrating digital health into heart failure management, TEXT4HF aims to make self-care more accessible and convenient, which could be especially beneficial for patients with limited mobility or those living in remote areas.

What evidence suggests that this text messaging intervention is effective for heart failure?

Research has shown that personalized text messages can help people manage heart failure more effectively. In this trial, participants in the TEXT4HF arm will receive tailored text messages in addition to usual care. Some studies have found that these messages can improve self-care by reminding patients to take their medication and maintain healthy habits. One study found that similar text message programs helped people take better care of themselves and reduced hospital visits. However, other research has not found significant changes in heart function. Despite these mixed results, text messaging remains a promising tool for managing heart failure. ^{2 3 4 5 6}

Who Is on the Research Team?

Jonathan W Leigh, MPH, MSHI

Principal Investigator

University of Illinois Chicago

Spyros Kitsiou, PhD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for older adults with heart failure who can receive text messages and are willing to participate in a study for 12 weeks. They should be able to complete questionnaires via text or phone calls. There's no specific mention of exclusion criteria provided.

Inclusion Criteria

I am 50 years old or older.

My heart failure is at a stage where I have symptoms.

Own a Mobile phone with TM plan

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Psychosis

Hospice or End-of-life care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires about self-care, quality of life, health beliefs, medications, and diet

1 week

1 visit (in-person or virtual)

Intervention

Participants receive tailored text messages targeting medication adherence, heart-healthy diet, and daily HF symptoms monitoring

12 weeks

5 text messages per week

Follow-up

Participants are monitored for changes in self-care and health beliefs through questionnaires at 4 and 12 weeks

12 weeks

2 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TEXT4HF

Trial Overview The TEXT4HF study tests if tailored text messaging helps improve self-care in patients with heart failure over a period of 12 weeks, compared to standard care alone. Participants will either get regular follow-ups and educational materials (control) or the same plus personalized texts about medication, diet, and symptom monitoring (intervention).

How Is the Trial Designed?

Group I: TEXT4HF Experimental Treatment 1 Intervention

In addition to usual care and a standard AHA information packet for patients with HF, participants in the intervention group will receive 5 tailored TMs/week for 12 weeks, targeting health beliefs about medication adherence, heart-healthy diet, self-monitoring, and heart failure knowledge.

Group II: Control Group Active Control 1 Intervention

The control group will receive standard HF medical care, which includes nurse-led patient education about HF self-care before and/or after discharge as well as follow-up visits at the Outpatient Heart Failure Clinic at UIH post-hospital discharge and several times per year or more, depending on the severity of the patient's condition. Participants will also receive the AHA information packet for patients with HF.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

A survey of 540 Chinese heart failure patients revealed that only about 70% were aware of their heart failure status and medication regimen, highlighting a significant gap in patient knowledge.

An overwhelming 95.6% of patients expressed willingness to receive SMS reminders and education to improve self-care, indicating that SMS could be an effective tool for enhancing self-management in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and Acceptability of Receiving SMS Self-care Messages in Chinese Patients With Heart Failure: An Inpatient Survey. Li, X., Chen, C., Qu, MY., et al.[2018]

The iHeartU mobile health app was developed to enhance self-management for heart failure patients, aiming to improve communication with healthcare providers and reduce hospital readmission rates.

Initial usability testing is underway, and the app is designed to be user-friendly and accessible, particularly for low-income patients, potentially leading to better health outcomes and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study. Zhang, L., Babu, SV., Jindal, M., et al.[2020]

A 24-week interactive text message-based mobile health intervention significantly improved self-care behaviors in heart failure patients, with notable increases observed between the first and third months of follow-up.

Patients using the text messaging program also showed higher disease knowledge compared to the control group, indicating that this intervention not only supports self-care but also enhances understanding of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a 24-week interactive text message-based mobile health intervention for enhancing self-care behaviours of patients with heart failure: A quasi-experimental study. Son, YJ., Kim, SW., Lee, WS., et al.[2023]

Healthcare providers (HCPs) believe that mobile apps can significantly enhance heart failure (HF) management by improving patient engagement, facilitating remote care, and providing educational support, based on interviews with 21 HCPs including cardiologists and nurses.

Challenges to app adoption include patient factors like age and technology access, but HCPs see potential in features like reminders and gamification to encourage adherence to treatment and self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Health Care Provider Perspectives on the Use of Mobile Apps to Support Patients With Heart Failure Management: Qualitative Descriptive Study. Sivakumar, B., Lemonde, M., Stein, M., et al.[2022]

In a study of 754 heart failure patients, 50% reported experiencing dizziness and 44% reported a dry cough, with these adverse effects leading to a 38% increased likelihood of medication changes.

Among the reported adverse effects, a dry cough was associated with the highest risk of medication change (1.83 times more likely), while patients reporting gout had a fourfold increase in the likelihood of starting or intensifying alleviating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of perceived adverse effects on medication changes in heart failure patients. De Smedt, RH., Jaarsma, T., Haaijer-Ruskamp, FM., et al.[2013]

In a study of 495 heart failure patients, 67% reported experiencing adverse drug events (ADEs) in the past month, with common symptoms including dry mouth and dizziness.

Patients who believed they had more disease symptoms and held negative beliefs about their medications were at a higher risk of experiencing ADEs, suggesting that addressing these perceptions could improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients: A cross-sectional survey. De Smedt, RH., Denig, P., van der Meer, K., et al.[2011]

In a study of 151 patients with systolic heart failure followed for about 10 months, treatment-related serious adverse events (SAEs) were common, but there was no significant difference in SAEs between those receiving NT-proBNP-guided care and standard care.

Patients who experienced SAEs had poorer quality of life and less improvement in heart function, and a risk score was developed to help predict which patients might be at higher risk for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and prediction of adverse events from intensive chronic heart failure management and effect on quality of life: results from the pro-B-type natriuretic peptide outpatient-tailored chronic heart failure therapy (PROTECT) study. Gandhi, PU., Szymonifka, J., Motiwala, SR., et al.[2015]

A study involving 37 heart failure patients showed that a significant majority (78.3%) believe technology could aid in managing their condition, indicating a positive perception of mobile health tools.

About 70.3% of participants expressed willingness to use technology for heart failure education and self-management, suggesting that mobile platforms could be effectively integrated into patient education programs for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Mobile Technology for Heart Failure Education and Self-Management Among Middle-Aged and Older Adults. Tarte, VP., Amirehsani, KA.[2020]

In a study of 1906 heart failure patients from the NHANES survey (1999-2018), only a small percentage met target goals for body mass index (19.09%) and waist circumference (27.38%), indicating poor control of these risk factors.

Adherence to recommended medications was also low, with only about half of patients taking beta blockers (54.77%) and ACE inhibitors/ARBs (52.62%), highlighting the need for improved strategies to optimize treatment and lifestyle changes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factor control among heart failure patients in the United States: Results from the NHANES 1999-2018. Tang, Y., Yan, J., Tang, L., et al.[2022]

A prototype of a sensor-controlled digital game (SCDG) was tested by 10 older adults with heart failure, who played it for an average of 6 out of 7 days, indicating good usability and engagement.

Participants reported that the SCDG was interesting and easy to use, with an average step count of 4,117 steps per week, suggesting it may effectively motivate physical activity and improve self-management of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Sensor-Controlled Digital Game to Engage Older Adults with Heart Failure in Physical Activity and Weight Monitoring. Radhakrishnan, K., Julien, C., O'Hair, M., et al.[2021]

In a study involving 767 patients with chronic heart failure, the use of SMS reminders after hospital discharge significantly reduced the rate of death or readmission at 180 days compared to usual care, indicating its efficacy in improving patient outcomes.

Both SMS and structured telephone support improved self-care behaviors, such as medication compliance and water restriction, compared to usual care, suggesting that these interventions can enhance patient management in chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-discharge short message service improves short-term clinical outcome and self-care behaviour in chronic heart failure. Chen, C., Li, X., Sun, L., et al.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/search/SYbVfXbVE0W0faPHCWU_ow/project-details/10639357

iCardia4HF This study addresses a critical gap in our understanding of the potential use of consumer mobile health technologies and individually tailored text messages to ...

2. researchgate.net researchgate.net/publication/397075490_A_Tailored_Text_Messaging_Intervention_Text4HF_to_Improve_Self-Care_in_Patients_with_Heart_Failure_Protocol_for_a_Pilot_Randomized_Controlled_Trial_Preprint

A Tailored Text Messaging Intervention (Text4HF) to ... A Tailored Text Messaging Intervention (Text4HF) to Improve Self-Care in Patients with Heart Failure: Protocol for a Pilot Randomized Controlled ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06205225

iCardia4HF: Multi-component mHealth Intervention for ... Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2812755

Multifaceted Strategy Based on Automated Text Messaging ... This randomized clinical trial evaluates the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after ...

5. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2023/12/13/15/58/multifaceted-strategy-based

Automated Text Messaging After HF Hospitalization A heart failure (HF) telemonitoring strategy delivered through text messages did not improve NT-proBNP levels or clinical outcomes when ...

6. trialx.com trialx.com/clinical-trials/listings/323276/text4hf-a-randomized-controlled-trial-of-a-tailored-text-messaging-intervention-to-improve-self-care-in-older-adult-patients-with-heart-failure/

TEXT4HF: A Randomized Controlled Trial of a Tailored ... TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure.