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

NCT06309875 | Not Yet Recruiting Phase 2

• 1 other identifier: ENF- 25-2018
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Caregiver Burden; Discharge Plan; Care Transitions; Nursing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

PLAN CUIDARTE

EXPERIMENTAL

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

Interventions

PLAN CUIDARTE OTHER

Description Plan Cuidarte

PLAN CUIDARTE

Conventional care OTHER

Description Conventional care

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de la Sabana: lead
• Universidad de Caldas: collaborator

Study Sites (1)

Universidad de Caldas

Manizales, Caldas Department, 170004., Colombia

Location

MeSH Terms

Conditions

Heart Failure; Caregiver Burden

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Alejandra Fuentes-Ramirez, DR

CONTACT

+573123722107; alejandra.fuentes@unisabana.edu.co

Gloria Carvajal-Carrascal, DR

CONTACT

+57 3115062590; gloria.carvajal@unisabana.edu.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test. The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later)

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 13, 2024
• Study Start: March 25, 2024
• Primary Completion: June 25, 2024
• Study Completion: November 12, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)