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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Caregiver Burden; Nursing; Care Transitions; Discharge Plan
• Intervention / Treatment: Other: Conventional care; Other: PLAN CUIDARTE

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alejandra Fuentes-Ramirez, DR; Phone Number: +573123722107; Email: alejandra.fuentes@unisabana.edu.co
• Study Contact Backup: Name: Gloria Carvajal-Carrascal, DR; Phone Number: +57 3115062590; Email: gloria.carvajal@unisabana.edu.co

Study Locations

• Colombia
  • Caldas
    • Manizales, Caldas, Colombia, 170004.
      • Universidad de Caldas
      • Contact: Claudia Marcela Vallejo, Mag; Phone Number: +573163614224; Email: marcela.vallejo@ucaldas.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; Set of specific activities carried out by the health care team by the health care team at the time of hospital discharge of HF patients: the patients with HF:	Other: Conventional care; Description Conventional care
Experimental: PLAN CUIDARTE; The "PLAN CUIDARTE" is an intervention aimed at addressing the hospital discharge of people with HF, based on the nursing theory of transitions of Afaf Meleis(46) and under the guidelines of Robin Whittemore for the systematic development of complex interventions for experimental type research in nursing. The PLAN CUIDARTE addresses the specific educational needs of HF patients, as established by the patients with HF, as established by international accreditation standards.	Other: PLAN CUIDARTE; Description Plan Cuidarte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad de la Sabana
• Collaborators: Universidad de Caldas

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): June 25, 2024
• Study Completion (Estimated): November 12, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Heart Failure; Caregiver Burden
• Other Study ID Numbers: ENF- 25-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No