Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure

Status Recruiting

Clinical Trial Summary

An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose

Clinical Trial Description

BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF. ;

Study Design

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT04424680
Study type	Interventional
Source	Hospital Universitario Fundación Alcorcón
Contact
Status	Recruiting
Phase	N/A
Start date	January 1, 2020
Completion date	January 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure — EACPAHFA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms