Clinical trial NCT04645290: Efficacy of a Multicomponent and Interdisciplinary Intervention on the Care Ability and Burden of Family Caregivers of People With Chronic Cardiocerebrovascular Diseases
Official title: Eficacia de Una intervención Multicomponente e Interdisciplinaria Sobre la Habilidad de Cuidado y Sobrecarga de Cuidadores Familiares de Personas Con Enfermedades crónicas Cardiocerebrovasculares
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregivers
Burnout, Psychological
Keywords: Cerebrovascular Disorders
Vascular Diseases
Treatment Outcome
Health Education
Interdisciplinary Research
Aptitud
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Fundación Universitaria Sanitas
name: Universidad Nacional de Colombia
name: Universidad de Santander
First posted: 2020-11-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind controlled clinical trial-type experimental design , with a mixed approach (QUAN + qual), with an intervention group and a control group.
Primary purpose: PREVENTION

Brief summary: The purpose of this intervention is to improve the caregiving ability of family caregivers of people with cardiovascular diseases and therefore reduce burden caregiver through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. The study will have two groups, one who will receive the intervention and the other with regular treatment.

Detailed description: Introduction: In Colombia it is anticipated that demographic changes will have the effect of increasing the number of older adults who will require care by families, accompanied by a greater demand for institutional care services, due to the prevalence and confluence of various chronic non-communicable diseases (NCD) in this age group, where cardiocerebrovascular diseases especially stand out, which can additionally generate functional sequelae in the patient at a physical and cognitive level. The presence of specifically cardiocerebrovascular CNCD compromises the sick person and their family caregiver, who assumes this function within the home without receiving any type of economic remuneration, training, social support or any type of additional service offered by the system to cope with this role. Taking great importance the ability to care on the part of the caregivers of these people and its impact on their survival and on the management of the disease. Additionally, the events that frame the care of a person with NCD, added to the demand for direct care and the lack of social support, can trigger the family caregiver to present overload. Therefore, it is essential to create and implement interventions that promote the caregiving ability of family caregivers, from different approaches and perspectives, so that a multicomponent and interdisciplinary intervention becomes essential in this process.

Objective: To determine the efficacy of a multicomponent and interdisciplinary intervention in B-Learning modality and a clinical simulation component on the ability to care and the burden on family caregivers of people with chronic cardio-cerebral vascular diseases in a condition of disability, of home care programs and home hospitalization in the cities of Bogotá and Bucaramanga.

Method: a study with an experimental design type double-blind controlled clinical trial (blinding of the people in charge of both initial and final measurements, and of those who perform the data analysis), with a mixed approach (QUAN + qual), with a group intervention and a control group. The study will be carried out in the cities of Bogotá and Bucaramanga. For the collection of the information, the characterization format of sociodemographic and clinical variables will be used for family caregivers and people in their care, the Ngozi Nkongho care skill instrument and the Zarit care burden instrument, mainly. Similarly, participant observation will be carried out in face-to-face workshops where the body dimension is addressed as a means for the recognition of family caregivers, their abilities and achievements. Likewise, focus groups will be held at the end of each workshop with the caregivers who wish to participate, until the theoretical saturation is achieved. The analysis of quantitative data will include descriptive statistics, inferential analysis, and a repeated measures ANOVA to assess the intragroup and intergroup effects of the response variables. The analysis of the qualitative data will be carried out using content analysis techniques (coding) and grounded theory (open and axial coding), and then carry out a data triagulation within the method (qualitative), to complement the understanding of the phenomenon. study and as validation. Finally, a methodological triangulation (between methods) will be carried out based on the general objective of the study.

Eligibility criteria: Inclusion Criteria:

* Caregivers aged 18 years or older.
* Be related to the person with cardiocerebrovascular disease in a condition of moderate to severe disability according to the Barthel scale.
* Having assumed the care of the person with a chronic illness in a condition of disability for a period greater than three months. (Note: if there is more than one family caregiver, the caregiver who has the longest stay in care and assistance will be selected).
* Know how to read and write.
* Have computer equipment and internet connectivity and a telephone
* Family caregivers residing in the cities of Bogotá and Bucaramanga.
* Accept voluntary participation in the study.

Exclusion Criteria:

* Family caregivers with cognitive and / or behavioral impairment that prevents them from participating in the research.
* Family caregivers of disabled people with cardiocerebrovascular disease, who are participating in other studies related to the topic of the research process.

Primary outcomes:
measure: Changes of mean score ability from baseline at 2 months
timeFrame: baseline at 2 months
measure: Changes of mean score of burden caregivers from baseline at 2 months
timeFrame: baseline at 2 months
Secondary outcomes:
measure: Qualitative results: perception about caring ability and burden caregivers
timeFrame: one month
Other outcomes:
measure: Changes of the score of self-perceived health from baseline at 2 months
timeFrame: baseline at 2 months
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
state: Bogota
city: Bogotá
country: Colombia
facility: Fundación Universitaria Sanitas
state: Bogotá D.C.
city: Bucaramanga
country: Colombia
facility: Universidad de Santander
state: Santander
Study officials:
affiliation: Fundación Universitaria Sanitas
name: Henry M Puerto Pedraza, RNs, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nkongho, N. O. (2003). The caring ability inventory. Measurement of nursing outcomes, 3, 184-198
citation: Carrillo G GM, Sanchez-Herrera B, Barrera-Ortiz L. [Caring ability of family caregivers of children with cancer]. Rev Salud Publica (Bogota). 2015 May;17(3):394-403. doi: 10.15446/rsap.v17n3.32408. Spanish.
citation: Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.