Clinical trial NCT06309875: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure
Official title: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure: Implementation of the Research Protocol.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Caregiver Burden
Discharge Plan
Care Transitions
Nursing
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
Collaborators: name: Universidad de Caldas
First posted: 2024-03-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Care Competence
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Manizales
country: Colombia
facility: Universidad de Caldas
state: Caldas
Study officials:
References: