Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure

Heart Failure Clinical Trial

— PLANCUIDARTE  

Official title:

Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure: Implementation of the Research Protocol.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309875
• Other study ID #: ENF- 25-2018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: November 12, 2024

Study information

• Verified date: March 2024
• Source: Universidad de la Sabana
• Contact: Alejandra Fuentes-Ramirez, DR
• Phone: +573123722107
• Email: alejandra.fuentes[@]unisabana.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.

The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HF

Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons.

Description:

Eligibility Criteria:

Inclusion criteria

• Patients over 18 years of age with a diagnosis of HF.

• Patients with HF who are hemodynamically stable.

• Patients with SPMSQ - PFERFFER of 0 - 4 errors or 5 errors, patient who has not received primary education.

• Patient with a PULSES of 6 to 11

Exclusion criteria

• Patients with heart failure with heart transplantation scheduled in the next 6 months.

• Patients requiring transfer to an intensive or intermediate care unit.

Outcome Measures:

• Primary: Caring competence.

• Secondary: Satisfaction with care

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 12, 2024
• Est. primary completion date: June 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age who are hospitalized and admitted to the institution with a diagnosis of HF decompensation with a time of diagnosis greater than 6 months.

• Patients who are hemodynamically stable, without alteration of the state of consciousness.

Exclusion Criteria:

• HF patients who are hospitalized for cardiac transplantation,

• Who are under palliative management or who, at the time of discharge, have a formal

• Who have a designated formal caregiver or are discharged to an institution other than home.

Related Conditions & MeSH terms

• Care Transitions
• Caregiver Burden
• Heart Failure
• Nursing

Intervention

Other:
• PLAN CUIDARTE
Description Plan Cuidarte
• Conventional care
Description Conventional care

Locations

Country	Name	City	State
Colombia	Universidad de Caldas	Manizales	Caldas

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de la Sabana	Universidad de Caldas

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Care Competence	capacity, ability and preparation of the patient or family caregiver to the patient or family caregiver to perform the task of caregiving(4), which is made up of the following five dimensions: knowledge five dimensions: knowledge, uniqueness, instrumental, enjoyment, anticipation and social relationship, uniqueness, instrumental, enjoyment, anticipation and social relationship.	30 days