TEXT4HF: Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
NCT Number: NCT06473532
Acronym: TEXT4HF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: BEHAVIORAL: TEXT4HF
Sponsor: University of Illinois at Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-30
Locations: University of Illinois, Chicago, Chicago, Illinois, 60612, United States

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 5 text messages/week targeting medication adherence, heart-healthy diet, and daily HF symptoms monitoring for 12 weeks.

Primary Outcome Measures: 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., 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., 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., Baseline, 4 weeks, 12 weeks
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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, 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, Baseline, 4 weeks, 12 weeks|Health Related Quality of Life, Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale, Baseline, 4 weeks, 12 weeks