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

NCT04645290 | Unknown DMC

• 1 other identifier: CEIFUS 389-19
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Caregivers; Burnout, Psychological

Keywords

Cerebrovascular Disorders; Vascular Diseases; Treatment Outcome; Health Education; Interdisciplinary Research; Aptitud

Outcome Measures

Primary Outcomes (2)

• 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

• 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 (\<or equal to 46), light burden (47 to 55), or heavy burden (\> or equal to 56)

  baseline at 2 months

Secondary Outcomes (1)

• Qualitative results: perception about caring ability and burden caregivers

  one month

Other Outcomes (1)

• Changes of the score of self-perceived health from baseline at 2 months

  baseline at 2 months

Study Arms (2)

Intervention group: Educational Intervention "KARER"

EXPERIMENTAL

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.

Behavioral: Intervention group: Educational Intervention "KARER"

Usual Care

NO INTERVENTION

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.

Interventions

Intervention group: Educational Intervention "KARER" 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.

Also known as: Educational Intervention "Karer"

Intervention group: Educational Intervention "KARER"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claudia Aristizábal: lead
• Fundación Universitaria Sanitas: collaborator
• Universidad Nacional de Colombia: collaborator
• Universidad de Santander: collaborator

Study Sites (3)

Fundación Universitaria Sanitas

Bogotá, Bogota D.C., 111321, Colombia

Location

Universidad Nacional de Colombia

Bogotá, Bogota D.C., 111321, Colombia

Location

Universidad de Santander

Bucaramanga, Santander Department, 680003, Colombia

Location

Related Publications (3)

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

  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.

  PMID: 28453089 BACKGROUND

• 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.

  PMID: 7203086 BACKGROUND

Related Links

• EQ-5D User Guides

MeSH Terms

Conditions

Burnout, Psychological; Cerebrovascular Disorders; Vascular Diseases; Health Education

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Henry M Puerto Pedraza, RNs, MSc.

  Fundación Universitaria Sanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of people in charge of both initial and final measurements, and of those who perform data analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinadora Unidad de Investigación

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

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 27, 2020
• Study Start: March 8, 2021
• Primary Completion: March 20, 2022
• Study Completion: June 30, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (3)