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Clinical Trials/NCT04645290
NCT04645290
Unknown
N/A

Eficacia de Una intervención Multicomponente e Interdisciplinaria Sobre la Habilidad de Cuidado y Sobrecarga de Cuidadores Familiares de Personas Con Enfermedades crónicas Cardiocerebrovasculares

Claudia Aristizábal3 sites in 1 country84 target enrollmentMarch 8, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Caregivers
Sponsor
Claudia Aristizábal
Enrollment
84
Locations
3
Primary Endpoint
Changes of mean score ability from baseline at 2 months
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2021
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Claudia Aristizábal
Responsible Party
Sponsor Investigator
Principal Investigator

Claudia Aristizábal

Coordinadora Unidad de Investigación

Sanitas University

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.

Outcomes

Primary Outcomes

Changes of mean score ability from baseline at 2 months

Time Frame: baseline at 2 months

It will measure with the "Caring Ability Inventory" (CAI): This instrument is composed of 37 items with a Likert-type graduation from 1 to 7, which are distributed in three subscales: knowledge, with 14 items, corage with 13 items, and patience with 10 items. The total score ranges from 37 to 259 points and the care ability is considered as: low (\<203.1), medium (203.1 to 220.3), high (\> 220.3).

Changes of mean score of burden caregivers from baseline at 2 months

Time Frame: baseline at 2 months

It will measure with the "Zarit Burden Interview", The Zarit scale score ranges from 22 to 110 points and the caregiver burden is considered as: no burden (\<or equal to 46), light burden (47 to 55), or heavy burden (\> or equal to 56)

Secondary Outcomes

  • Qualitative results: perception about caring ability and burden caregivers(one month)

Study Sites (3)

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