跳至主要内容
临床试验/NCT04645290
NCT04645290Unknown不适用

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

Claudia Aristizábal6 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
84
试验地点
6
主要终点
Changes of mean score ability from baseline at 2 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding of people in charge of both initial and final measurements, and of those who perform data analysis

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes of mean score ability from baseline at 2 months

时间窗: 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

时间窗: 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)

次要结局

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

研究者

发起方
Claudia Aristizábal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Claudia Aristizábal

Coordinadora Unidad de Investigación

Sanitas University

研究点 (6)

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