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Effectiveness Program Caregivers Care

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Educative intervention:
Sponsored by
Universidad de Santander
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring Ability Care, Caregiver overload, Family caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Family caregivers of people with chronic non-communicable disease attending the University Hospital Los Comuneros in Bucaramanga.
  • Family caregivers for a minimum period of three months
  • Be of age

Exclusion Criteria:

  • Carers with communication difficulties
  • Caregivers difficulty understanding

Sites / Locations

  • Santander, ColombiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educative intervention

Control group

Arm Description

Who wish to participate in the program "Caring for Caregivers" will be the intervention group. The intervention or program "Caring for Caregivers" to develop was proposed by the Group of Chronic Care Patient and Family School of Nursing at the National University of Colombia. This program includes four sessions or meetings with the caretaker, induction and three modules, the first is geared to strengthen the knowledge; the second, to strengthen the value and the third, to strengthen patience.

The control group will receive training about knowledge of chronic disease and care. In addition, once it confirmed the effectiveness of the intervention participants in the control group will be contacted to contemplate the possibility of receiving the benefits of the intervention.

Outcomes

Primary Outcome Measures

Care ability
For the measurement of the ability to care Inventory Skill Care (Caring Ability Inventory, CAI) version in Spanish from the original version of Nkongho.

Secondary Outcome Measures

Burden of care
To assess the perception of the burden of care which manages a multidimensional measure the level of care Survey Zarit Burden, an instrument was used caregiver burden perceives its responsibility to care for the person.

Full Information

First Posted
May 17, 2017
Last Updated
November 21, 2019
Sponsor
Universidad de Santander
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1. Study Identification

Unique Protocol Identification Number
NCT03159728
Brief Title
Effectiveness Program Caregivers Care
Official Title
Efect of Program Caregivers of With Chronic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Santander

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In Colombia as in the world, chronic diseases occupy the first places of death being cardiovascular, chronic respiratory diseases and diabetes mellitus are the most prevalent. The caregiver burden is reflected as an experience of constant attention, this routine is shown in the changes they undergo in their life, and the emotions cope at different stages of the process that arises chronic non-communicable disease from their family in demands care. Methodology: a randomized controlled trial (RCT) will be conducted to determine the effect of skill care program "Caring for the caregivers" to reduce the burden of care in carers of people with chronic non-communicable University Hospital in Los Comuneros in Bucaramanga. Results and expected impact: bring to the lines of research: Community Care: improve the ability of the care of family caregivers at home and increase the quality of life that people are able to chronicity. Clinical Care: Strengthens care ability of caregivers who are in health institutions. Management and Care Management: Promoting implementation, monitoring and evaluation of the educational proposal in order to create a network of support for family caregivers in Santander in extending the results to other institutions. The project results should allow participation in Extension and Social Projection, whose results will allow the implementation of an effective educational model for the care of patients with chronic non-communicable disease in Colombia. In addition, the consolidation of the alliance between Everest group at the University of Santander with the Latin American Network of chronic patient care and clinical Communards of Bucaramanga projects. Finally it is expected to consolidate training in the area of research students in undergraduate and graduate programs at the University of Santander.
Detailed Description
Chronic noncommunicable diseases (NCDs) are the cause of increased consumption of socio-health resources, this in time and costs of medication these patients, added to this is the aging population that has drawn the attention of economists, politicians, health workers and researchers. At present, the change in the population pyramid is one of the factors that caused the increase in chronic diseases, which are the leading cause of morbidity and mortality worldwide. (Campos, M. Moya, D. Mendoza, D. Child, E., 2014). The presence of chronic non-communicable diseases makes it of interest of the whole society including the government, private sector and academia, twenty-one making it more advantageous and cost-effective strategies are needed as new media and thus strengthen the capacity of health services to respond to NCDs. (World Health Organization, 2012). For other part of the (NCCD) usually are long and slow evolution, affecting all age groups and all regions regardless of condition social, besides also they characterized by total or partial loss of autonomy seeing the person who has it must depend wholly or partly from a caregiver who provides security and support during his illness and in the process of recovery, This requires that promote the development of knowledge and skills in people with chronic non-communicable diseases and their caregivers and form social and support networks to facilitate better adaptation process against disease, through sources that allow you to collect systematize and disseminate information in order to improve the level of knowledge and induce changes to behaviors and lifestyles that promote physical and mental health care cuidadorsujeto dyad. (Herrera, A. Florez, I. Romero, E. Montalvo, A. Physical, psychological, social and spiritual implications of chronic non-communicable disease (NCD), affect not only the sufferer, but also their family caregiver (5), which substantiates the need to go beyond the organic approach the same; thus the social support family caregivers of people with NCDs takes importance. (Barrera, L. Campos, M. Carreño, S. Carrillo M, Chaparro,L. Jaimes, M. Ortiz, S. Piratoba, B. Rosales, R. Sánchez, B., 2013) According Colliere quoted by Campos, CARE is an act of life that means an infinite variety of activities to sustain life and enable continuity and reproduction. Garcia says that caring is a habitual simple activity in humans, continually practiced as an integral part of the daily activities of people, to answer the essential aspiration to meet the needs. (Campos, M. Moya, D. Mendoza, D. Child, E., 2014) Escudero says Sitter is "the person or family, which provides most of the care and daily support who suffers from a disease or require assistance for the development of activities of daily living, without receiving financial remuneration" (Campos, M. Moya, D. Mendoza, D. Child, E., 2014) In Colombia in the study by Barreto and collaborators reported that most care for his family since the beginning of the NCCD, with exceeding seven months and more than seven hours per day times, which can mean an oppressive and incompatible work with a good quality of life. However, just over half report not only carers and have braces, spiritual and social family. Additionally it was found that 8.6% of caregivers reported dysfunction and, particularly, 3.6% reflecting deterioration in mental status, thus the risk of the occurrence of adverse events for themselves and their families with NCDs is very high. (Barreto, R. Campos, M. González, G. Coral, R. Chaparro, L. Duran, M, et al, 2015) This study also found that knowledge and access to information and communication technologies (ICT), mostly middle and upper part, constitute an invaluable opportunity for social support for this group; only 42.8% of caregivers reported healthy. The results corroborate the charge that the role of caregiver is associated with extensive wear and confirm findings from different studies analyzing the burden of care. (Barreto, R. Campos, M. González, G. Coral, R. Chaparro, L. Duran, M, et al, 2015). This study adopts the concept of skill care proposed by Nkongho as a multidimensional concept with three dimensions including knowledge, courage and patience. From these principles Nkongho ability develops the concept of care as "the ability to help others grow in a relationship that involves process development." (Eterovic, C. Mendoza, S. Saenz, K. 2015) This project is a research derived "Program Decreased Burden of Chronic Disease Transmissible No (NCDs) in Colombia". In which a pilot test where the results showed the felt need for an educational program on the ability of care in family caregivers of patients with chronic disease was made. This justifies the realization of this project will allow participation in Extension and Social Outreach, an effective educational model for caregivers of people with non-communicable chronic disease in Colombia. In addition, the consolidation of the alliance between Everest group at the University of Santander with the Latin American Network of chronic patient care and teaching hospital in Bucaramanga The Communards projects. Finally it is expected to consolidate training in the area of research students in undergraduate and graduate programs in specialization in Quality Management and Audit in Health at the University of Santander.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Ability Care, Caregiver overload, Family caregiver

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educative intervention
Arm Type
Experimental
Arm Description
Who wish to participate in the program "Caring for Caregivers" will be the intervention group. The intervention or program "Caring for Caregivers" to develop was proposed by the Group of Chronic Care Patient and Family School of Nursing at the National University of Colombia. This program includes four sessions or meetings with the caretaker, induction and three modules, the first is geared to strengthen the knowledge; the second, to strengthen the value and the third, to strengthen patience.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive training about knowledge of chronic disease and care. In addition, once it confirmed the effectiveness of the intervention participants in the control group will be contacted to contemplate the possibility of receiving the benefits of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Educative intervention:
Intervention Description
In the induction of the new group members are present, including caregivers who start the program and those who coordinated. In Module I: to strengthen the knowledge of the situation and the people involved in care. In Module II: to strengthen the value in the caregiver through decision making, skill and social support to back it up. In Module III: or end, after analyzing that uneasy caregiver, patience is reviewed through the meaning of family care and self.
Primary Outcome Measure Information:
Title
Care ability
Description
For the measurement of the ability to care Inventory Skill Care (Caring Ability Inventory, CAI) version in Spanish from the original version of Nkongho.
Time Frame
within the first 90 days
Secondary Outcome Measure Information:
Title
Burden of care
Description
To assess the perception of the burden of care which manages a multidimensional measure the level of care Survey Zarit Burden, an instrument was used caregiver burden perceives its responsibility to care for the person.
Time Frame
within the first 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Family caregivers of people with chronic non-communicable disease attending the University Hospital Los Comuneros in Bucaramanga. Family caregivers for a minimum period of three months Be of age Exclusion Criteria: Carers with communication difficulties Caregivers difficulty understanding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia C Torres, RN, MSc
Phone
57-7-6516500
Ext
1221
Email
claudiaconsuelo@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid N Páez, RN, MSc
Phone
57-7-6516500
Ext
1221
Email
nathaliapaez1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia C Torres, RN, MSc
Organizational Affiliation
Universidad de Santander
Official's Role
Study Director
Facility Information:
Facility Name
Santander, Colombia
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia C Torres, RN, MSc
Phone
57-7-6516500
Ext
1221
Email
claudiaconsuelo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Astrid N Páez, RN, MSc
Phone
57-7-6516500
Ext
1221
Email
nathaliapaez1@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness Program Caregivers Care

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