Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Noncommunicable chronic diseases are pathologies that over time require skills in the patient and family caregiver; to ensure safe and continuous care once they are discharged from health institutions. The approach of them represents multiple challenges in need of greater communication and education; for this, the importance of generating strategies through different interventions must be taken into account.

In this order of ideas, the program Plan of discharge or discharge consists of a coordinated intervention and executed by nursing staff that captures the patient dyad with chronic illness-family caregiver from his admission, stay and hospital discharge. The previous approach consists of a systematized guide that contemplates the following activities: 1) assessment of the family caregiver patient dyad to define the competence for care in the home (CARING), the level of risk and complexity of the care associated with the treatment in the home, according to defined risk: polypharmacy, parenteral medications, control medications and / or invasive devices; 2) education and instruction to the patient and the family caregiver during the hospital stay, anticipating the care needs at the time of discharge, with delivery of booklets, brochures and instructions, and 3) telephone follow-up for up to one month, by means of a 2-call call. week. (Melo Melo, Vargas Hernández, Carrrillo, & Alarcón Trujillo, 2017).

In a study carried out by (Sanchez, Carrillo Gonzalez, & Barrera, 2014) they refer that there exists a great variety of literature on the plan of transition and hospital discharge, in which it is possible to evidence a heterogeneous level opposite to concrete guidelines, to advance these plans, although this management is recommended in benefit of the users since the evidence on the effectiveness of the development of plans of care, as fundamental part of the continuous, safe and integral care of the patients and their families is very limited.

The support of professionals, institutions and the health system must respond to these demands to ensure the right to quality care for the sick person and the support required by his or her family caregiver, as well as other factors that influence access, security, continuity, social support with the use of appropriate information and communication technology and the strengthening of capacities for self-management and competence for care. (Carrillo Gonzalez , Sanchez Herrera, Gomez, Carreño, & Chaparro Diaz, 2017).

It is important to highlight that in a study conducted by (Sara Gutiérrez 2014) its objective was to identify the way of educating both the patient and the family at the time of discharge, it was possible to identify that the nursing staff does not give education to patients of the instructions issued by the medical staff; patients and their caregivers do not understand the care received and therefore 86% do not comply with the latest indications as well as 50% of re-entries is given for not having understood or had education in front of the care and instructions given at the time of discharge of the patient. (Gutierrez Suarez & Freire, 2014).

Regarding Effectiveness of the egress or transition plan for safe, comprehensive and continuous care, a trend is shown that would allow recommending the hospital transition and discharge plan, to support continuity, facilitate change, specify the guideline, avoid complications and decrease avoidable cost in patients with chronic, non-communicable disease. (Gutierrez Suarez & Freire, 2014)

On the other hand (Ginarte Arias, 2001) comments that in the majority of cases the patient and / or caregiver is blamed in the adherence; However, 'it is suggested that public policies and the health system could be directly related to the cause of non-adherence to treatment.' (Ginarte Arias, 2001) In addition, the weaknesses of the Health System contribute to the problem.

To assess adherence, different instruments have been designed, the most appropriate for this study being the Therapeutic Adherence Scale: it contains three factors, each with seven items distributed as follows: Control over the intake of medicines and foods, Medical follow-up behavioral and self-efficacy. Adherence is measured as a percentage, with 100 patients adhering. In this order of ideas, this instrument allows the evaluation of adherence in chronic diseases, without being directed to a specific disease. On the other hand, the authors have concluded that this scale identifies behavioral characteristics of patients, which favor or not their adherence to treatment (Soria Trujano, Vega Valero, & Navas Quiroz, 2009).

Program of Transition - Discharge Hospital, is based on strategies that can reduce adherence to treatment being predictive and key factors among which are: 'lack of knowledge of the disease, the therapeutic regimen and the consequences of non-compliance by the patient; lack of an adequate relationship between the patient and the doctor, complexity and long duration of treatment, asymptomatic disease, inadequate follow-up or lack of an elaborate plan on the abandonment of the medication; presence of adverse effects, cost of medication and / or copayment, failure to attend medical appointments, presence of psychological problems such as depression or anxiety, beliefs and perceptions of the patient. The transition and hospital discharge program starts from the patient's admission to hospital. the institution and the medication and presence of cognitive difficulties '. (Dilla, Valladares, Lizán, & Sacristán, 2009)

This research proposal is in the context and is articulated with the Comprehensive Health Care Policy (PAIS), where it addresses the different actors of the Health System to intervene in the social determinants that promote the health of people with chronic diseases. . It also shows the importance of intervening in public health with programs that in a short period contribute in a concrete way to the operative component in the Model of Integral Health Care (MIAS). (Ministry of Health and Social Protection, 2016) ;


Study Design


Related Conditions & MeSH terms

  • Treatment Adherence and Compliance

NCT number NCT04175860
Study type Interventional
Source Universidad de Santander
Contact María S Campos de Aldana, Msc
Phone 3176608313
Email al.campos@mail.udes.edu.co
Status Not yet recruiting
Phase N/A
Start date November 30, 2019
Completion date February 28, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05202964 - Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Completed NCT04778163 - The Use of Humor With Young Adults in Psychiatric Care N/A
Not yet recruiting NCT04184739 - Quality and Effectiveness of a Personalised App to Support Patients With Fixed Braces N/A
Not yet recruiting NCT06229171 - InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention N/A
Not yet recruiting NCT05123638 - VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation N/A
Recruiting NCT04117269 - External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers N/A
Recruiting NCT06070441 - Adherence to Exercises for Neck Pain. N/A
Recruiting NCT04893928 - Role of Information and Communication Technologies for Health Support in Inflammatory Bowel Diseases: The DAMASCO Trial
Active, not recruiting NCT04696861 - Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania N/A
Active, not recruiting NCT05907174 - Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care N/A
Completed NCT05261308 - Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture N/A
Completed NCT04509076 - PrEP iT! Mobile App Intervention N/A
Completed NCT05282173 - Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa N/A
Completed NCT05260203 - MargheRITA (Remote Intelligence for Therapeutic Adherence) N/A
Recruiting NCT04656028 - Genetic Testing and Motivational Counseling for FH N/A
Not yet recruiting NCT06442072 - Global Controlled Trial on Effects of an Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity: Comparing Versions With IFS vs. CBT, Buddy- vs. Group-, Standard- vs. Minimum-Guidance Intensity. N/A
Completed NCT04674085 - Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis
Active, not recruiting NCT05889702 - Kentucky Access to Recovery Evaluation
Recruiting NCT05286632 - KidneYou - Innovative Digital Therapy N/A
Recruiting NCT06354465 - Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews