Effectiveness Program Caregivers Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03159728
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : July 13, 2017
Information provided by (Responsible Party):
Universidad de Santander

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: Educative intervention: Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efect of Program Caregivers of With Chronic Diseases
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Educative intervention
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.
Behavioral: Educative intervention:
  • 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.

No Intervention: Control group

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.

Primary Outcome Measures :
  1. Care ability [ Time Frame: within the first 90 days ]
    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 :
  1. Burden of care [ Time Frame: within the first 90 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03159728

Contact: Claudia C Torres, RN, MSc 57-7-6516500 ext 1221
Contact: Astrid N Páez, RN, MSc 57-7-6516500 ext 1221

Santander, Colombia Recruiting
Bucaramanga, Santander, Colombia, 680003
Contact: Claudia C Torres, RN, MSc    57-7-6516500 ext 1221   
Contact: Astrid N Páez, RN, MSc    57-7-6516500 ext 1221   
Sponsors and Collaborators
Universidad de Santander
Study Director: Claudia C Torres, RN, MSc Universidad de Santander

Responsible Party: Universidad de Santander Identifier: NCT03159728     History of Changes
Other Study ID Numbers: 039-2015
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad de Santander:
Ability Care
Caregiver overload
Family caregiver

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes