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Efficacy of a Multicomponent and Interdisciplinary Intervention on the Care Ability and Burden of Family Caregivers of People With Chronic Cardiocerebrovascular Diseases

NCT ID: NCT04645290

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Caregivers Burnout, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind controlled clinical trial-type experimental design , with a mixed approach (QUAN + qual), with an intervention group and a control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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Intervention group: Educational Intervention "KARER"

General objective of the intervention: Implement self-care strategies and care actions aimed at people facing chronic diseases with disabilities, applying knowledge, ability and attitudes that allow them to act in a timely manner, reducing the risk of complications, improving well-being and the quality of life of the person cared for and of himself. Through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support.

Group Type EXPERIMENTAL

Intervention group: Educational Intervention "KARER"

Intervention Type BEHAVIORAL

Multicomponent and interdisciplinary intervention on the care ability and burden of family caregivers. It consists of:

Virtual componet

* Module 0: the introduction
* Module 1: called "Identifying my role as a caregiver"
* Module 2: called "Strategies to strengthen care"
* Module 3: called "Strengthening my caring skills"

Face-to-face componed - Two seasons of 4 hours each

Simulation component

\- One season of practices abilities of 4 hours.

Usual Care

The people assigned to this group will receive their own responses from the institution providing care services to which they belong. These instructions consist of: information on the disease process and treatment received from the medical group, information on assistance by the nursing group and finally, the administrative procedures carried out by social work.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention group: Educational Intervention "KARER"

Multicomponent and interdisciplinary intervention on the care ability and burden of family caregivers. It consists of:

Virtual componet

* Module 0: the introduction
* Module 1: called "Identifying my role as a caregiver"
* Module 2: called "Strategies to strengthen care"
* Module 3: called "Strengthening my caring skills"

Face-to-face componed - Two seasons of 4 hours each

Simulation component

\- One season of practices abilities of 4 hours.

Intervention Type BEHAVIORAL

Other Intervention Names

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Educational Intervention "Karer"

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Universitaria Sanitas

UNKNOWN

Sponsor Role collaborator

Universidad Nacional de Colombia

OTHER

Sponsor Role collaborator

Universidad de Santander

OTHER

Sponsor Role collaborator

Claudia Aristizábal

OTHER

Sponsor Role lead

Responsible Party

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Claudia Aristizábal

Coordinadora Unidad de Investigación

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henry M Puerto Pedraza, RNs, MSc.

Role: PRINCIPAL_INVESTIGATOR

Fundación Universitaria Sanitas

Locations

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Fundación Universitaria Sanitas

Bogotá, Bogota D.C., Colombia

Site Status

Universidad Nacional de Colombia

Bogotá, Bogota D.C., Colombia

Site Status

Universidad de Santander

Bucaramanga, Santander Department, Colombia

Site Status

Countries

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Colombia

References

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Nkongho, N. O. (2003). The caring ability inventory. Measurement of nursing outcomes, 3, 184-198

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 28453089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7203086 (View on PubMed)

Related Links

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https://euroqol.org/publications/user-guides/

EQ-5D User Guides

Other Identifiers

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CEIFUS 389-19

Identifier Type: -

Identifier Source: org_study_id