NCT03159728

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

November 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

May 17, 2017

Last Update Submit

November 21, 2019

Conditions

Keywords

Ability CareCaregiver overloadFamily caregiver

Outcome Measures

Primary Outcomes (1)

  • 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.

    within the first 90 days

Secondary Outcomes (1)

  • Burden of care

    within the first 90 days

Study Arms (2)

Educative intervention

EXPERIMENTAL

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:

Control group

NO INTERVENTION

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.

Interventions

* 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.

Educative intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Carers with communication difficulties
  • Caregivers difficulty understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santander, Colombia

Bucaramanga, Santander Department, 680003, Colombia

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia C Torres, RN, MSc

    Universidad de Santander

    STUDY DIRECTOR

Central Study Contacts

Claudia C Torres, RN, MSc

CONTACT

Astrid N Páez, RN, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

June 15, 2017

Primary Completion

December 30, 2019

Study Completion

March 30, 2020

Last Updated

November 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations