Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-04 @ 11:49 PM
Study NCT ID:
NCT06473532
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-Care Maintenance', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Change in Self-care Symptom Perception', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Change in Self-care self-management', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Health Beliefs about Medication Compliance', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Health Beliefs about Dietary Compliance', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Health Beliefs about Self-Monitoring Compliance', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Heart Failure knowledge', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Atlanta Heart Failure Knowledge Questionnaire (30-items). Scored range is 0 to 30 with higher scored indicating better knowledge about heart failure.'}, {'measure': 'Change in Self-care confidence (self-efficacy)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': '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.'}, {'measure': 'Medication and Refill adherence', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Assessed with Adherence to Refilling Medication Scale (ARMS); 12 Items, 4-point Likert scale, lower scores indicate better adherence'}, {'measure': 'Heart Healthy Diet Adherence', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Assessed with Scale for Dietary Behaviors in Heart Failure (SDBHF); 19 Items, 4-point Likert scale, higher scores indicate better adherence'}, {'measure': 'Heart Failure Quality of Life', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'mHealth', 'Text Messaging', 'Mobile Phone'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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:\n\n* Is a tailored text messaging intervention feasible and acceptable among older adult patients with heart failure?\n* Does tailored text messaging improve self-care in adult patients with heart failure?\n\nParticipants 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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nThis 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥50 years of Age\n* HF Stage C, NYHA Class I-IV and on a loop diuretic\n* Own a Mobile phone with Text message plan\n* Ability to speak and read English\n* 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)\n\nExclusion Criteria:\n\n* SAVR/TAVR or Ventricular Assist Device, or Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) scheduled within the next 3 months\n* Coronary revascularization, and/or CRT-implantation within the last 30 days (EMR Review)\n* Psychosis\n* Hospice or End-of-life care\n* Advanced Renal disease (i.e., estimated Glomerular Filtration Rate \\<25 or Hemodialysis)\n* Cognitive impairment (i.e., Dementia, Alzheimer's)\n* Unable to self-manage (take medication, bathe, use the toilet, etc.)\n* Currently living in a nursing home"}, 'identificationModule': {'nctId': 'NCT06473532', 'acronym': 'TEXT4HF', 'briefTitle': 'TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure', 'orgStudyIdInfo': {'id': '2022-0704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEXT4HF', 'description': '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.', 'interventionNames': ['Behavioral: TEXT4HF']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "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."}], 'interventions': [{'name': 'TEXT4HF', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['TEXT4HF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan W Leigh, MPH, MSHI', 'role': 'CONTACT', 'email': 'leighj@uic.edu', 'phone': '312-355-3261'}, {'name': 'Spyros Kitsiou, PhD', 'role': 'CONTACT', 'email': 'skitsiou@uic.edu', 'phone': '312-355-3519'}, {'name': 'Jonathan W Leigh, MPH, MSHI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Spyros Kitsiou, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Illinois, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Jonathan W Leigh, MPH, MSHI', 'role': 'CONTACT', 'email': 'leighj@uic.edu', 'phone': '312-355-3261'}, {'name': 'Spyros Kitsiou, PhD', 'role': 'CONTACT', 'email': 'skitsiou@uic.edu'}], 'overallOfficials': [{'name': 'Jonathan W Leigh, MPH, MSHI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois Chicago'}, {'name': 'Spyros Kitsiou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Illinois Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Jonathan W. Leigh', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}