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.
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:
- Type of treatment
- Lifestyle or therapy programme
- 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.
Colombia1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted19 May 2017
- Study start15 Jun 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia C Torres, RN, MSc, Study director, Universidad de Santander
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efect of Program Caregivers of With Chronic Diseases
- ClinicalTrials.gov ID
- NCT03159728
- Acronym / sponsor ID
- 039-2015
- Conditions
- Chronic Disease
- Keywords
- Ability Care, Caregiver overload, Family caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de SantanderUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educative intervention | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Carers with communication difficulties
- Caregivers difficulty understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Educative intervention |
Primary outcome
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.
1 secondary outcome
Burden of care
Time frame: within the first 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia C Torres, RN, MSc study director
Universidad de Santander
1 site in 1 country: see every site and its status.
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.