AzTrials
AzTrials

Chronic DiseaseNCT03159728

Effectiveness Program Caregivers Care

A study testing Educative intervention: in people with Chronic Disease, run by Universidad de Santander at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Educative intervention:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteColombia
Study dates
15 Jun 2017to 30 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Carers with communication difficulties
  • Caregivers difficulty understanding

Trial locations and contacts

1 site in 1 country.

Claudia C Torres, RN, MSc contact

57-7-6516500 ext. 1221

claudiaconsuelo@yahoo.com

Colombia1 site, 1 recruiting
  • Santander, Colombia

    Bucaramanga, Santander Department, 680003

    Claudia C Torres, RN, MSc, 57-7-6516500 ext. 1221, claudiaconsuelo@yahoo.com

    Astrid N Páez, RN, MSc, 57-7-6516500 ext. 1221, nathaliapaez1@hotmail.com

    Recruiting

Other trials in Colombia

About this study

Official title: Efect of Program Caregivers of With Chronic Diseases

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.

Read the 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.

Conditions
Chronic Disease
Being tested
Educative intervention:
Keywords
Ability Care, Caregiver overload, Family caregiver
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educative intervention:Behavioural

    • 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.
Study groups in NCT03159728
Study groupRoleWhat they receive
Educative interventionExperimentalWho 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.
Receives: Behavioral: Educative intervention:
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within the first 90 days

Secondary outcomes (1)
  1. 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.

    Measured: within the first 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start15 Jun 2017
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03159728
Sponsor's protocol ID
039-2015
Status last verified
Oct 2019
First submitted
17 May 2017
Last updated
22 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Educative intervention: in people with Chronic Disease, run by Universidad de Santander at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claudia C Torres, RN, MSc (57-7-6516500 ext. 1221, claudiaconsuelo@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Care ability (time frame: within the first 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in