NCT04062461: IC-CBC

Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients

Status unknown NA Last updated 2 March 2023

What this trial tests

NA trial testing Multifaceted strategy based on sending text messages(SMS) in Heart Failure in 704 participants. Status unknown.

Timeline

8 July 2019

Primary endpoint
6 January 2023

30 April 2023

Quick facts

Lead sponsor	Hospital do Coracao
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	704
Start date	8 July 2019
Primary completion	6 January 2023
Estimated completion	30 April 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Multifaceted strategy based on sending text messages(SMS)
• Usual outpatient care

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Hospital do Coracao

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. mHealth education interventions in heart failure.
   Allida S, Du H, Xu X, Prichard R, et al · · 2020 · cited 47× · PMID 32613635 · DOI 10.1002/14651858.cd011845.pub2
2. Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.
   Rohde LE, Rover MM, Hoffmann Filho CR, Rabelo-Silva ER, et al · · 2024 · cited 7× · PMID 38055237 · DOI 10.1001/jamacardio.2023.4501