Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT04062461
Brief Summary:
Study Design: A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS)to patients with heart failure.
Methodological quality:
* Central randomization with allocation concealment;
* Decision committee for blind outcome assessment;
* Intention-to-treat analysis
Detailed Description:
Study Design -A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS) to patients with heart failure.
Methodological quality
-Central randomization with allocation concealment; Decision committee for blind outcome assessment; Intention-to-treat analysis
Primary Objective -To develop and evaluate the feasibility of a monitoring, education and self-care strategy to optimize the management of patients with heart failure (HF) after hospital discharge.
Secondary Objectives
-To evaluate, in patients with heart failure, the effect of a self-care promotion program using a multifaceted strategy in comparison to the usual care about acceptability to the application of SMS, patient and / or family satisfaction with care, quality of life scales health scales, self-care scales and knowledge on HF, visual analog scale of dyspnea, and clinical outcomes at 30 and 180 days.
Experimental group:
-Self-care promotion using a multifaceted strategy based on the use of a tele-monitoring device, based on short message system (SMS) messages and self-care teaching tools.
Patients will receive daily messages to optimize self-care in heart failure with the following functions:
* customized reminders about medication schedules
* weight and symptoms of decompensation monitoring assessing a decision tree with diuretics adjustment if needed and alerts that define the need to contact a health professional for early intervention before deterioration of the clinical state, identifying situations that require clinical intervention.
* educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)
* diary for registration of visits to health services and clinical setting.
Control group:
-Usual outpatient care
Follow-up
* Follow up will be at least 180 days from the inclusion in the study.
* Sample size estimation 350 patients per group (700 patients)
Study:
NCT04062461
Study Brief:
Protocol Section:
NCT04062461