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

Caregivers Clinical Trial

— Emiicare  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04645290
• Other study ID #: CEIFUS 389-19
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: Sanitas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 84
• Est. completion date: June 30, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregivers

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Colombia	Fundación Universitaria Sanitas	Bogotá	Bogotá D.C.
Colombia	Universidad Nacional de Colombia	Bogotá	Bogota
Colombia	Universidad de Santander	Bucaramanga	Santander

Sponsors (4)

Lead Sponsor	Collaborator
Claudia Aristizábal	Fundación Universitaria Sanitas, Universidad de Santander, Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

Carrillo G GM, Sánchez-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. — View Citation

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

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of the score of self-perceived health from baseline at 2 months	It will measure with the "The EQ-5D cuestionary": The EQ5D descriptive system is made up of five dimensions which are: 1) mobility, 2) self-care, 3) habitual activities, 4) pain or discomfort, and 5) anxiety and depression. These in turn are divided into five levels of perceived problems. A unique state of health is defined by combining one level from each of the five dimensions. In this way, a total of 3125 possible health states are defined. Each state is named by a 5-digit code. The second part of the instrument is made up of a visual analog scale from 0 to 100, the perception of the state of health at the time of measurement.	baseline at 2 months
Primary	Changes of mean score ability from 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).	baseline at 2 months
Primary	Changes of mean score of burden caregivers from 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 (	baseline at 2 months
Secondary	Qualitative results: perception about caring ability and burden caregivers	Participant observation each face-to-face and simulation season and focal groups in the last face to face season: The participant observation will be carried out from the moment the face-to-face workshops begin, and will extend until the product of the observations is decreasing, that is, when the data begins to be repeated and no important new apprehensions are achieved.; The focus groups will be held after the completion of the exploration and body expression workshops, with the participants who wish to do so. The context of the focus groups will be the same place of the workshop. It will be ensured that the focus groups do not last longer than 1 hour, in order not to interrupt the activities of family caregivers. The focus groups will be recorded in audio and will be transcribed as soon as they are held.; This qualitative results will be focused in the perception of change experienced by the family caregivers about their caring ability and burden.	one month

External Links

•   EQ-5D User Guides