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

NCT06309875 — Phase 2, Unknown, 84 participants, Universidad de la Sabana

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

Registry	NCT06309875, acronym PLANCUIDARTE
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	84 (Estimated)
Sponsor	Universidad de la Sabana (Other); collaborators: Universidad de Caldas
Conditions	Heart Failure, Caregiver Burden, Discharge Plan, Care Transitions, Nursing
Interventions	PLAN CUIDARTE, Conventional care (Other)
Dates	start 2024-03-25 (estimated), primary completion 2024-06-25 (estimated), completion 2024-11-12 (estimated), first posted 2024-03-13, last updated 2024-03-13
Locations	1 site in Colombia

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Conventional	Active comparator	Other: Conventional care	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:
PLAN CUIDARTE	Experimental	Other: 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.

PLAN CUIDARTE (Other): Description Plan Cuidarte
Conventional care (Other): Description Conventional care

+Outcome measures

Primary outcomes

Care Competence [30 days]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Universidad de Caldas	Manizales, Caldas Department	Colombia