NCT06731166

Brief Summary

The goal of this clinical trial is to measure the effectiveness of video monitoring associated with the transition of care for patients with heart failure. The main questions it aims to answer is: Is video monitoring superior to monitoring via audio calls in patients with heart failure? Researchers will compare monitoring by video to a monitoring by audio to see if drug videomonitoring works to improve selfcare in heart failure and other outocomes. Participants will: intervention group receive video calls guided by cardiologist nurses at 7, 30, 60, 180 and 365 days after hospital discharge. the control group will receive audio calls for data collection, at the same time mentioned.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jun 2025Jun 2028

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

December 9, 2024

Last Update Submit

March 12, 2026

Conditions

Keywords

Heart FailureNursing CareClinical TrialTelenursing

Outcome Measures

Primary Outcomes (1)

  • Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure

    European Self-Care Scale The European self-care scale consists of 12 questions with a single domain related to self-care behavior. Responses to each item range from 1, "I completely agree", to 5, "I completely disagree", following a five-point Likert scale. The total score is obtained by summing all the responses, which can range from 12 to 60. Low values indicate better self-care. The items concern the various self-care behaviors of patients with heart failure, such as checking daily weight (item 1), rest (items 2 and 7), seeking help from the healthcare team (items 3, 4, 5 and 8), fluid restriction (item 6), diet (item 9), medication adherence (item 10), flu vaccination (item 11) and exercise (item 12)

    365 days after discharge

Other Outcomes (5)

  • Hospitalization Rates for Heart Failure within 365 Days Post-Discharge

    365 days after discharge

  • Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire

    365 days after discharge

  • Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"

    365 days after discharge

  • +2 more other outcomes

Study Arms (2)

Videomonitoring Group

EXPERIMENTAL

Videomonitoring by cardiovascular nursing

Behavioral: self-care

Voice call group

NO INTERVENTION

Voice call by cardiovascular nurses

Interventions

self-careBEHAVIORAL

Videomonitoring provide by cardiovascular nurses using motivational interview and teach-back

Videomonitoring Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older;
  • Admitted for decompensated HFrEF
  • Ejection fraction less than 40% confirmed by echocardiogram performed in the last 3 months
  • Who access to a mobile device with internet access

You may not qualify if:

  • heart transplant waiting list;
  • who had undergone coronary artery bypass in the last 3 months ;
  • who were in palliative care;
  • who had a life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlândia

Uberlândia, Minas Gerais, 38405354, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Self Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • OMAR DE ALMEIDA NETO, PhD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Almeida de Almeida Neto, PhD

CONTACT

Patricia magnabosco, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

After careful consideration, we have decided not to share the individual patient data (IPD) from this study. This decision was made based on privacy concerns, participant confidentiality, and the specifics of the informed consent, which does not explicitly include authorization for sharing individual data. Furthermore, the study involves sensitive data that could compromise participants' privacy, even with anonymization and de-identification processes. Ensuring the safety and well-being of participants remains our top priority, and therefore, we have opted not to make individual data available on public platforms or repositories. The aggregated results and conclusions of the study will be shared through scientific publications, conferences, and other appropriate platforms to ensure that the findings benefit the scientific community and society at large.

Locations