Adherence to the Transition-discharge-hospital Plan in Patient-family Caregiver With Chronic Pathology

NCT04175860 | Unknown DMC

• 1 other identifier: CIF 0314-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the therapeutic adherence of the patient-family caregiver with non-communicable chronic disease through the hospital transition-discharge plan program in a second level institution in the metropolitan area of Bucaramanga. Methods: The study will be a randomized controlled clinical trial in 100 participants who meet the inclusion criteria, distributed in a 1: 1 ratio for the intervention group and the control group, considering a confidence level of 90%, power of 80% and a reduction of 30%. Expected results: demonstrate the relevance of the program in the target population through the formation of information mechanisms between the parties involved in direct care, the development of skills and safety at home; the timely identification of the risks inherent to clinical conditions or possible complications associated with care, which aim to reduce the burdens related to the health - disease experience; also emphasize the continuity of the treatment established. On the other hand, achieve a more informed professional performance, prepared, transparent, that responds to the needs and expectations of the user in terms of monitoring and comprehensive therapeutic management. Impact: It is expected that this research will be the basis for the protocolization and implementation of the hospital discharge transition plan program in the health institution and subsequently develop a prospective study on a larger scale, which will allow evaluating its impact on the target population in order to reduce the complications, re-admissions and costs derived from the care of chronic patients.

Conditions

Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (1)

• 1. Adherence to treatment

  Scale of therapeutic adherence for patients with chronic diseases, based on explicit behaviors developed by Rocio Soria Trujano, Cynthia Zaira Vega Valero and Carlos Nava Quiroz of the Facultad de Estudios Superiores Iztacala UNAM. Mexico.

  within the first 30 days

Secondary Outcomes (1)

• 1. Competence for care

  within the first 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Consists of a series of non-pharmacological preventive interventions that will focus on the - transition-discharge-hospital program including individualized non-pharmacological interventions such as dyad characterization, competency assessment, risk assessment, inherent program strategies, and monitoring. The intervention or program " Hospital Discharge Plan" to develop was proposed by the Group of Chronic Care Patient and Family School of Nursing at the National University of Colombia. This program includes an educational session and weekly telephone follow-up according to the patient's risk characterization.

Behavioral: The intervention with the patient (Chronic Patient Care Group and his family.)

Control group

NO INTERVENTION

This group of patients-family caregivers will be carried out the discharge activities that are regularly developed in the second level institution and recorded in a check-sheet and field diary.

Interventions

The intervention with the patient (Chronic Patient Care Group and his family.) BEHAVIORAL

* Characterization: through the application of the characterization survey of the dyad (patient-caregiver), * Evaluation of the competence to care at home: Application of the instrument 'competence to care at home, long and short version both the patient and the family caregiver. * Risk assessment: this step is made based on the complexity of the treatment and the results of the evaluation the competence to care at home.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Patient with chronic pathology hospitalized in a second level institution in Floridablanca.
• Patient resident in the metropolitan area of Bucaramanga
• Patients over 18 years of age
• Patient with diagnosis at least 6 months old

You may not qualify if:

• People with communication difficulties.
• Patients with a health condition that at the time of the interview does not allow them to participate in the study.

Sponsors & Collaborators

• Universidad de Santander: lead

Study Sites (1)

ESE Hospital San Juan de Dios Floridablanca

Floridablanca, Santander Department, 681002, Colombia

Location

Related Publications (7)

• Carrillo-González, G. M., Barreto-Osorio, R. V., Arboleda, L. B., Gutiérrez-Lesmes, O. A., Melo, B. G., & Ortiz, V. T. (2015). Competencia para cuidar en el hogar de personas con enfermedad crónica y sus cuidadores en Colombia. Revista de la Facultad de Medicina, 63(4), 665-675.

  BACKGROUND

• González, G. M. C., Herrera, B. S., Ramírez, O. J. G., Moreno, S. P. C., & Díaz, L. C. (2017). Metodología de implementación del "plan de egreso hospitalario" para personas con enfermedad crónica en Colombia. Revista Med de la Facultad de Medicina, 25(2), 55-62.

  BACKGROUND

• Mabel Carrillo G, Sanchez Herrera B, Arias Rojas EM. Validation of an instrument to assess the homecare competency of the family caregiver of a person with chronic disease. Invest Educ Enferm. 2015 Dec;33(3):449-455. doi: 10.17533/udea.iee.v33n3a08.

  PMID: 28569952 BACKGROUND

• Dilla T, Valladares A, Lizan L, Sacristan JA. [Treatment adherence and persistence: causes, consequences and improvement strategies]. Aten Primaria. 2009 Jun;41(6):342-8. doi: 10.1016/j.aprim.2008.09.031. Epub 2009 May 7. No abstract available. Spanish.

  PMID: 19427071 BACKGROUND

• familia, G. d. (s.f.). Bogotá: Universidad Nacional de Colombia. Ginarte Arias, Y. (2001). La adherencia terapéutica. Revista Cubana de Medicina general Integral, 502-505.

  BACKGROUND

• Gutierrez Suarez, S., & Freire, C. (2014). Plan de egreso del paciente en el cuidado de enfermeria: cumplimiento en pacientes del área de Medicina Interna del hospita Pablo Arturo Suarez. Chile: Universidad de las americas.

  BACKGROUND

• Melo Melo BG, Vargas Hernandez Y, Carrillo GM, Alarcon Trujillo DK. Effect of the programme Plan de egreso on chronically ill patients and their family caregivers. Enferm Clin (Engl Ed). 2018 Jan-Feb;28(1):36-43. doi: 10.1016/j.enfcli.2017.09.006. Epub 2017 Nov 17. English, Spanish.

  PMID: 29153438 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• María S Campos de Aldana, Msc

  Universidad de Santander

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María S Campos de Aldana, Msc

CONTACT

3176608313; al.campos@mail.udes.edu.co

Astrid N Paez Esteban, Msc

CONTACT

6516500; nathaliapaez1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: November 30, 2019
• Primary Completion: November 30, 2020
• Study Completion: February 28, 2021
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)