Heart FailureTEXT4HFNCT06473532
TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
A study testing TEXT4HF in people with Heart Failure, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- TEXT4HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥50 years of Age
- HF Stage C, NYHA Class I-IV and on a loop diuretic
- Own a Mobile phone with Text message plan
- Ability to speak and read English
- Suboptimal HF self-care. (SCHFI Score of 3 or less in at least 2 items of any subscale: Self-care maintenance, Symptom Perception, or Self-management)
Who cannot join
- SAVR/TAVR or Ventricular Assist Device, or Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) scheduled within the next 3 months
- Coronary revascularization, and/or CRT-implantation within the last 30 days (EMR Review)
- Psychosis
- Hospice or End-of-life care
- Advanced Renal disease (i.e., estimated Glomerular Filtration Rate <25 or Hemodialysis)
- Cognitive impairment (i.e., Dementia, Alzheimer's)
- Unable to self-manage (take medication, bathe, use the toilet, etc.)
- Currently living in a nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Chicago
Chicago, Illinois, 60612
About this study
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?
Read more
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 self-monitoring for 12 weeks.
Read the detailed description
Heart failure (HF) is a serious chronic condition and the most common hospital discharge diagnosis among older adults in the United States. Almost 7 million Americans are diagnosed with HF and new cases are rapidly rising at a rate of nearly 1 million per year. This feasibility pilot randomized controlled trial will be conducted using individually tailored text message (TM) intervention, delivered to improve HF self-care adherence.
This randomized controlled trial in older adult patients (≥50 years of age) with HF to determine the feasibility (recruitment capability, acceptability), and preliminary efficacy of the Text4HF intervention compared with usual care over 12 weeks. Thirty (n=30) adult patients from the University of Illinois Hospital \& Health Sciences System (UIH) will be randomly assigned to the intervention or usual care group. Patients in the TM intervention (TEXT4HF) will receive messages that target the most common self-care factors known to precipitate HF hospitalizations (medication adherence, heart-healthy diet, and self-monitoring).
- Conditions
- Heart Failure
- Being tested
- TEXT4HF
- Keywords
- Heart Failure, mHealth, Text Messaging, Mobile Phone
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEXT4HFBehavioural
In addition to usual care, participants in the intervention group will receive 5 TMs/week for 12 weeks at a time of their preference. Tailoring of the TMs is performed based on participants' responses to validated questionnaires (health beliefs scales, HF-knowledge scale, and self-efficacy about HF self-care scale), administered at baseline and 4 weeks. They will also receive an AHA HF discharge informational packet.
| Study group | Role | What they receive |
|---|---|---|
| TEXT4HF | Experimental | 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. Receives: Behavioral: TEXT4HF |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Care Maintenance
Self-care maintenance will be measured with Subscale A of the Self-Care Heart Failure Index (SCHFI) v.7.2, which includes 10-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Measured: Baseline, 4 weeks, 12 weeks
Change in Self-care Symptom Perception
Self-care symptom perception will be measured the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale B, which includes 9-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Measured: Baseline, 4 weeks, 12 weeks
Change in Self-care self-management
Self-care self-management will be measured with the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale C, which includes 8-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (8)
Health Beliefs about Medication Compliance
Beliefs about Medication Compliance Scale (12-items)The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 6-30. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.
Measured: Baseline, 4 weeks, 12 weeks
Health Beliefs about Dietary Compliance
Beliefs about Dietary Compliance Scale (12 items)The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 6-30. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.
Measured: Baseline, 4 weeks, 12 weeks
Health Beliefs about Self-Monitoring Compliance
Beliefs about Self-Monitoring Scale (18 items). The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 18-90. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.
Measured: Baseline, 4 weeks, 12 weeks
Heart Failure knowledge
Atlanta Heart Failure Knowledge Questionnaire (30-items). Scored range is 0 to 30 with higher scored indicating better knowledge about heart failure.
Measured: Baseline, 4 weeks, 12 weeks
Change in Self-care confidence (self-efficacy)
Self-care confidence ill be measured with the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale D, which includes 10-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Measured: Baseline, 4 weeks, 12 weeks
Medication and Refill adherence
Assessed with Adherence to Refilling Medication Scale (ARMS); 12 Items, 4-point Likert scale, lower scores indicate better adherence
Measured: Baseline, 4 weeks, 12 weeks
Heart Healthy Diet Adherence
Assessed with Scale for Dietary Behaviors in Heart Failure (SDBHF); 19 Items, 4-point Likert scale, higher scores indicate better adherence
Measured: Baseline, 4 weeks, 12 weeks
Heart Failure Quality of Life
Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start26 Sep 2024
- Primary completion10 Feb 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W Leigh, MPH, MSHI, Principal investigator, University of Illinois ChicagoSpyros Kitsiou, PhD, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473532
- Sponsor's protocol ID
- 2022-0704
- Acronym
- TEXT4HF
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leigh JW, Pressler SJ, Gerber BS, Kansal M, Cajita M, Kitsiou S. Tailored Text Messaging Intervention to Improve Self-Care in Patients With Heart Failure (Text4HF): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 24;15:e86667. doi: 10.2196/86667.
PubMed 42497360
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06473532
- Acronym / sponsor ID
- TEXT4HF / 2022-0704
- Conditions
- Heart Failure
- Keywords
- Heart Failure, mHealth, Text Messaging, Mobile Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 self-monitoring for 12 weeks.
Detailed description
Heart failure (HF) is a serious chronic condition and the most common hospital discharge diagnosis among older adults in the United States. Almost 7 million Americans are diagnosed with HF and new cases are rapidly rising at a rate of nearly 1 million per year. This feasibility pilot randomized controlled trial will be conducted using individually tailored text message (TM) intervention, delivered to improve HF self-care adherence.
This randomized controlled trial in older adult patients (≥50 years of age) with HF to determine the feasibility (recruitment capability, acceptability), and preliminary efficacy of the Text4HF intervention compared with usual care over 12 weeks. Thirty (n=30) adult patients from the University of Illinois Hospital \& Health Sciences System (UIH) will be randomly assigned to the intervention or usual care group. Patients in the TM intervention (TEXT4HF) will receive messages that target the most common self-care factors known to precipitate HF hospitalizations (medication adherence, heart-healthy diet, and self-monitoring).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEXT4HF | Experimental | Behavioral: TEXT4HFIn 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. |
| Control Group | No 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 may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥50 years of Age
- HF Stage C, NYHA Class I-IV and on a loop diuretic
- Own a Mobile phone with Text message plan
- Ability to speak and read English
- Suboptimal HF self-care. (SCHFI Score of 3 or less in at least 2 items of any subscale: Self-care maintenance, Symptom Perception, or Self-management)
Key exclusion criteria (8 listed)
- SAVR/TAVR or Ventricular Assist Device, or Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) scheduled within the next 3 months
- Coronary revascularization, and/or CRT-implantation within the last 30 days (EMR Review)
- Psychosis
- Hospice or End-of-life care
- Advanced Renal disease (i.e., estimated Glomerular Filtration Rate <25 or Hemodialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEXT4HFIn addition to usual care, participants in the intervention group will receive 5 TMs/week for 12 weeks at a time of their preference. Tailoring of the TMs is performed based on participants' responses to validated questionnaires (health beliefs scales, HF-knowledge scale, and self-efficacy about HF self-care scale), administered at baseline and 4 weeks. They will also receive an AHA HF discharge informational packet. | Behavioural | TEXT4HF |
Primary outcome
Change in Self-Care Maintenance
Time frame: Baseline, 4 weeks, 12 weeks
Self-care maintenance will be measured with Subscale A of the Self-Care Heart Failure Index (SCHFI) v.7.2, which includes 10-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Change in Self-care Symptom Perception
Time frame: Baseline, 4 weeks, 12 weeks
Self-care symptom perception will be measured the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale B, which includes 9-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Change in Self-care self-management
Time frame: Baseline, 4 weeks, 12 weeks
Self-care self-management will be measured with the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale C, which includes 8-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
8 secondary outcomes
Health Beliefs about Medication Compliance
Time frame: Baseline, 4 weeks, 12 weeks
Health Beliefs about Dietary Compliance
Time frame: Baseline, 4 weeks, 12 weeks
Health Beliefs about Self-Monitoring Compliance
Time frame: Baseline, 4 weeks, 12 weeks
Heart Failure knowledge
Time frame: Baseline, 4 weeks, 12 weeks
Change in Self-care confidence (self-efficacy)
Time frame: Baseline, 4 weeks, 12 weeks
Medication and Refill adherence
Time frame: Baseline, 4 weeks, 12 weeks
Heart Healthy Diet Adherence
Time frame: Baseline, 4 weeks, 12 weeks
Heart Failure Quality of Life
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42497360Leigh JW, Pressler SJ, Gerber BS, Kansal M, Cajita M, Kitsiou S. Tailored Text Messaging Intervention to Improve Self-Care in Patients With Heart Failure (Text4HF): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 24;15:e86667. doi: 10.2196/86667.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Leigh, MPH, MSHI principal investigator
University of Illinois Chicago
Spyros Kitsiou, PhD study chair
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEXT4HF in people with Heart Failure, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Care Maintenance (time frame: Baseline, 4 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.