Heart Failure
Conditions
Keywords
Heart Failure, mHealth, Text Messaging, Mobile Phone
Brief 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? * 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).
Interventions
BEHAVIORALTEXT4HF
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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Care Maintenance | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure knowledge | Baseline, 4 weeks, 12 weeks | Atlanta Heart Failure Knowledge Questionnaire (30-items). Scored range is 0 to 30 with higher scored indicating better knowledge about heart failure. |
| Change in Self-care confidence (self-efficacy) | Baseline, 4 weeks, 12 weeks | 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. |
| Health Beliefs about Medication Compliance | Baseline, 4 weeks, 12 weeks | 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. |
| Heart Healthy Diet Adherence | Baseline, 4 weeks, 12 weeks | Assessed with Scale for Dietary Behaviors in Heart Failure (SDBHF); 19 Items, 4-point Likert scale, higher scores indicate better adherence |
| Heart Failure Quality of Life | Baseline, 4 weeks, 12 weeks | Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale |
| Medication and Refill adherence | Baseline, 4 weeks, 12 weeks | Assessed with Adherence to Refilling Medication Scale (ARMS); 12 Items, 4-point Likert scale, lower scores indicate better adherence |
| Health Beliefs about Dietary Compliance | Baseline, 4 weeks, 12 weeks | 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. |
| Health Beliefs about Self-Monitoring Compliance | Baseline, 4 weeks, 12 weeks | 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. |
Countries
United States
Contacts
Primary ContactJonathan W Leigh, MPH, MSHI
Backup ContactSpyros Kitsiou, PhD
Outcome results
None listed