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

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine whether an individually tailored text messaging intervention can improve self-care in older adult patients with heart failure. The main question it aims to answer are: * Is a tailored text messaging intervention feasible and acceptable among older adult patients with heart failure? * Does tailored text messaging improve self-care in adult patients with heart failure? Participants will be randomly assigned to one of two groups for 12 weeks: 1) intervention (text messaging); or 2) control group. Both groups will receive usual care, which includes regular follow-up visits at the heart failure clinic (standard care), plus a "Discharge Packet for Patients Diagnosed with Heart Failure", developed by the American Heart Association. Both groups will be asked via text messages and/or telephone calls to complete questionnaires at baseline/start, 4 weeks and 12 weeks, about self-care, quality of life, health beliefs, medications, diet, etc. Participants assigned to the intervention group will also receive approximately 5 text messages/week targeting medication adherence, heart-healthy diet, and daily HF symptoms monitoring for 12 weeks.

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 data supports the effectiveness of the treatment TEXT4HF for heart failure?

Research shows that using text messages to support heart failure patients can improve their self-care behaviors and reduce hospital readmissions. This suggests that the TEXT4HF treatment, which uses text messaging, may help patients manage their condition better. ^{1 2 3 4 5}

Is text messaging for heart failure safe for humans?

The research does not provide specific safety data for text messaging interventions like TEXT4HF, but it suggests that using text messages to support self-care in heart failure patients is generally considered acceptable and does not mention any safety concerns. ^{1 6 7 8 9}

How is the TEXT4HF treatment different from other heart failure treatments?

TEXT4HF is unique because it uses text messaging to improve self-care behaviors in heart failure patients, helping them manage their condition better after leaving the hospital. Unlike traditional treatments that focus on medication or devices, this approach emphasizes patient engagement and education through mobile technology. ^{1 3 6 10 11}

Research Team

Jonathan W Leigh, MPH, MSHI

Principal Investigator

University of Illinois Chicago

Spyros Kitsiou, PhD

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

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.

Currently living in a nursing home

I have not had heart surgery or a CRT device implanted in the last 30 days.

Timeline

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)

Treatment Details

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).

Participant Groups

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 of symptoms, 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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Canada 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Post-discharge short message service improves short-term clinical outcome and self-care behaviour in chronic heart failure. [2021]

4. Canada 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. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Risk factor control among heart failure patients in the United States: Results from the NHANES 1999-2018. [2022]

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

Perceptions and Acceptability of Receiving SMS Self-care Messages in Chinese Patients With Heart Failure: An Inpatient Survey. [2018]

7. England 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. [2011]

8. United States 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. [2015]

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

The impact of perceived adverse effects on medication changes in heart failure patients. [2013]

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

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

11. Germany 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. [2021]