CaregiversEmiicareNCT04645290
Efficacy of a Multicomponent and Interdisciplinary Intervention on the Care Ability and Burden of Family Caregivers of People With Chronic Cardiocerebrovascular Diseases
A study testing Intervention group: Educational Intervention "KARER" in people with Caregivers and Burnout, Psychological, run by Claudia Aristizábal at 3 sites in Colombia.
Trial summary
The purpose of this intervention is to improve the caregiving ability of family caregivers of people with cardiovascular diseases and therefore reduce burden caregiver through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Burnout, Psychological
- What is being tested?
- Intervention group: Educational Intervention "KARER"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesColombia
- Study dates
- 8 Mar 2021to 30 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers aged 18 years or older.
- Be related to the person with cardiocerebrovascular disease in a condition of moderate to severe disability according to the Barthel scale.
- Having assumed the care of the person with a chronic illness in a condition of disability for a period greater than three months. (Note: if there is more than one family caregiver, the caregiver who has the longest stay in care and assistance will be selected).
- Know how to read and write.
- Have computer equipment and internet connectivity and a telephone
- Family caregivers residing in the cities of Bogotá and Bucaramanga.
- Accept voluntary participation in the study.
Who cannot join
- Family caregivers with cognitive and / or behavioral impairment that prevents them from participating in the research.
- Family caregivers of disabled people with cardiocerebrovascular disease, who are participating in other studies related to the topic of the research process.
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
Fundación Universitaria Sanitas
Bogotá, Bogota D.C., 111321
Universidad Nacional de Colombia
Bogotá, Bogota D.C., 111321
Universidad de Santander
Bucaramanga, Santander Department, 680003
About this study
Official title: Eficacia de Una intervención Multicomponente e Interdisciplinaria Sobre la Habilidad de Cuidado y Sobrecarga de Cuidadores Familiares de Personas Con Enfermedades crónicas Cardiocerebrovasculares
The purpose of this intervention is to improve the caregiving ability of family caregivers of people with cardiovascular diseases and therefore reduce burden caregiver through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. The study will have two groups, one who will receive the intervention and the other with regular treatment.
Read the detailed description
Introduction: In Colombia it is anticipated that demographic changes will have the effect of increasing the number of older adults who will require care by families, accompanied by a greater demand for institutional care services, due to the prevalence and confluence of various chronic non-communicable diseases (NCD) in this age group, where cardiocerebrovascular diseases especially stand out, which can additionally generate functional sequelae in the patient at a physical and cognitive level. The presence of specifically cardiocerebrovascular CNCD compromises the sick person and their family caregiver, who assumes this function within the home without receiving any type of economic remuneration, training, social support or any type of additional service offered by the system to cope with this role. Taking great importance the ability to care on the part of the caregivers of these people and its impact on their survival and on the management of the disease. Additionally, the events that frame the care of a person with NCD, added to the demand for direct care and the lack of social support, can trigger the family caregiver to present overload. Therefore, it is essential to create and implement interventions that promote the caregiving ability of family caregivers, from different approaches and perspectives, so that a multicomponent and interdisciplinary intervention becomes essential in this process.
Objective: To determine the efficacy of a multicomponent and interdisciplinary intervention in B-Learning modality and a clinical simulation component on the ability to care and the burden on family caregivers of people with chronic cardio-cerebral vascular diseases in a condition of disability, of home care programs and home hospitalization in the cities of Bogotá and Bucaramanga.
Method: a study with an experimental design type double-blind controlled clinical trial (blinding of the people in charge of both initial and final measurements, and of those who perform the data analysis), with a mixed approach (QUAN + qual), with a group intervention and a control group. The study will be carried out in the cities of Bogotá and Bucaramanga. For the collection of the information, the characterization format of sociodemographic and clinical variables will be used for family caregivers and people in their care, the Ngozi Nkongho care skill instrument and the Zarit care burden instrument, mainly. Similarly, participant observation will be carried out in face-to-face workshops where the body dimension is addressed as a means for the recognition of family caregivers, their abilities and achievements. Likewise, focus groups will be held at the end of each workshop with the caregivers who wish to participate, until the theoretical saturation is achieved. The analysis of quantitative data will include descriptive statistics, inferential analysis, and a repeated measures ANOVA to assess the intragroup and intergroup effects of the response variables. The analysis of the qualitative data will be carried out using content analysis techniques (coding) and grounded theory (open and axial coding), and then carry out a data triagulation within the method (qualitative), to complement the understanding of the phenomenon. study and as validation. Finally, a methodological triangulation (between methods) will be carried out based on the general objective of the study.
- Conditions
- Caregivers, Burnout, Psychological
- Being tested
- Intervention group: Educational Intervention "KARER"
- Keywords
- Cerebrovascular Disorders, Vascular Diseases, Treatment Outcome, Health Education, Interdisciplinary Research, Aptitud
- Medical subject headings
- Burnout, Psychological, Cerebrovascular Disorders, Vascular Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group: Educational Intervention "KARER"Behavioural
Also called Educational Intervention "Karer"
Multicomponent and interdisciplinary intervention on the care ability and burden of family caregivers. It consists of:
Virtual componet
- Module 0: the introduction
- Module 1: called "Identifying my role as a caregiver"
- Module 2: called "Strategies to strengthen care"
- Module 3: called "Strengthening my caring skills"
Face-to-face componed - Two seasons of 4 hours each
Simulation component
- One season of practices abilities of 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Educational Intervention "KARER" | Experimental | General objective of the intervention: Implement self-care strategies and care actions aimed at people facing chronic diseases with disabilities, applying knowledge, ability and attitudes that allow them to act in a timely manner, reducing the risk of complications, improving well-being and the quality of life of the person cared for and of himself. Through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. Receives: Behavioral: Intervention group: Educational Intervention "KARER" |
| Usual Care | No intervention | The people assigned to this group will receive their own responses from the institution providing care services to which they belong. These instructions consist of: information on the disease process and treatment received from the medical group, information on assistance by the nursing group and finally, the administrative procedures carried out by social work. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of mean score ability from baseline at 2 months
It will measure with the "Caring Ability Inventory" (CAI): This instrument is composed of 37 items with a Likert-type graduation from 1 to 7, which are distributed in three subscales: knowledge, with 14 items, corage with 13 items, and patience with 10 items. The total score ranges from 37 to 259 points and the care ability is considered as: low (<203.1), medium (203.1 to 220.3), high (> 220.3).
Measured: baseline at 2 months
Changes of mean score of burden caregivers from baseline at 2 months
It will measure with the "Zarit Burden Interview", The Zarit scale score ranges from 22 to 110 points and the caregiver burden is considered as: no burden (<or equal to 46), light burden (47 to 55), or heavy burden (> or equal to 56)
Measured: baseline at 2 months
Secondary outcomes (1)
Qualitative results: perception about caring ability and burden caregivers
Participant observation each face-to-face and simulation season and focal groups in the last face to face season: The participant observation will be carried out from the moment the face-to-face workshops begin, and will extend until the product of the observations is decreasing, that is, when the data begins to be repeated and no important new apprehensions are achieved.
The focus groups will be held after the completion of the exploration and body expression workshops, with the participants who wish to do so. The context of the focus groups will be the same place of the workshop. It will be ensured that the focus groups do not last longer than 1 hour, in order not to interrupt the activities of family caregivers. The focus groups will be recorded in audio and will be transcribed as soon as they are held.
This qualitative results will be focused in the perception of change experienced by the family caregivers about their caring ability and burden.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start8 Mar 2021
- Primary completion20 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies 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
- Model description
- Double-blind controlled clinical trial-type experimental design , with a mixed approach (QUAN + qual), with an intervention group and a control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Universitaria Sanitas, Universidad Nacional de Colombia, Universidad de Santander
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Henry M Puerto Pedraza, RNs, MSc., Principal investigator, Fundación Universitaria Sanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645290
- Sponsor's protocol ID
- CEIFUS 389-19
- Acronym
- Emiicare
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Manuscript, Scientific Congress's, Share the results with the participants at the end of the research
Publications
Nkongho, N. O. (2003). The caring ability inventory. Measurement of nursing outcomes, 3, 184-198
Carrillo G GM, Sanchez-Herrera B, Barrera-Ortiz L. [Caring ability of family caregivers of children with cancer]. Rev Salud Publica (Bogota). 2015 May;17(3):394-403. doi: 10.15446/rsap.v17n3.32408. Spanish.
PubMed 28453089Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficacia de Una intervención Multicomponente e Interdisciplinaria Sobre la Habilidad de Cuidado y Sobrecarga de Cuidadores Familiares de Personas Con Enfermedades crónicas Cardiocerebrovasculares
- ClinicalTrials.gov ID
- NCT04645290
- Acronym / sponsor ID
- Emiicare / CEIFUS 389-19
- Conditions
- Caregivers, Burnout, Psychological
- Keywords
- Cerebrovascular Disorders, Vascular Diseases, Treatment Outcome, Health Education, Interdisciplinary Research, Aptitud
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Fundación Universitaria Sanitas, Universidad Nacional de Colombia, Universidad de Santander
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Nov 2020 (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.
The purpose of this intervention is to improve the caregiving ability of family caregivers of people with cardiovascular diseases and therefore reduce burden caregiver through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. The study will have two groups, one who will receive the intervention and the other with regular treatment.
Detailed description
Introduction: In Colombia it is anticipated that demographic changes will have the effect of increasing the number of older adults who will require care by families, accompanied by a greater demand for institutional care services, due to the prevalence and confluence of various chronic non-communicable diseases (NCD) in this age group, where cardiocerebrovascular diseases especially stand out, which can additionally generate functional sequelae in the patient at a physical and cognitive level. The presence of specifically cardiocerebrovascular CNCD compromises the sick person and their family caregiver, who assumes this function within the home without receiving any type of economic remuneration, training, social support or any type of additional service offered by the system to cope with this role. Taking great importance the ability to care on the part of the caregivers of these people and its impact on their survival and on the management of the disease. Additionally, the events that frame the care of a person with NCD, added to the demand for direct care and the lack of social support, can trigger the family caregiver to present overload. Therefore, it is essential to create and implement interventions that promote the caregiving ability of family caregivers, from different approaches and perspectives, so that a multicomponent and interdisciplinary intervention becomes essential in this process.
Objective: To determine the efficacy of a multicomponent and interdisciplinary intervention in B-Learning modality and a clinical simulation component on the ability to care and the burden on family caregivers of people with chronic cardio-cerebral vascular diseases in a condition of disability, of home care programs and home hospitalization in the cities of Bogotá and Bucaramanga.
Method: a study with an experimental design type double-blind controlled clinical trial (blinding of the people in charge of both initial and final measurements, and of those who perform the data analysis), with a mixed approach (QUAN + qual), with a group intervention and a control group. The study will be carried out in the cities of Bogotá and Bucaramanga. For the collection of the information, the characterization format of sociodemographic and clinical variables will be used for family caregivers and people in their care, the Ngozi Nkongho care skill instrument and the Zarit care burden instrument, mainly. Similarly, participant observation will be carried out in face-to-face workshops where the body dimension is addressed as a means for the recognition of family caregivers, their abilities and achievements. Likewise, focus groups will be held at the end of each workshop with the caregivers who wish to participate, until the theoretical saturation is achieved. The analysis of quantitative data will include descriptive statistics, inferential analysis, and a repeated measures ANOVA to assess the intragroup and intergroup effects of the response variables. The analysis of the qualitative data will be carried out using content analysis techniques (coding) and grounded theory (open and axial coding), and then carry out a data triagulation within the method (qualitative), to complement the understanding of the phenomenon. study and as validation. Finally, a methodological triangulation (between methods) will be carried out based on the general objective of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind controlled clinical trial-type experimental design , with a mixed approach (QUAN + qual), with an intervention group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Educational Intervention "KARER" | Experimental | Behavioral: Intervention group: Educational Intervention "KARER"General objective of the intervention: Implement self-care strategies and care actions aimed at people facing chronic diseases with disabilities, applying knowledge, ability and attitudes that allow them to act in a timely manner, reducing the risk of complications, improving well-being and the quality of life of the person cared for and of himself. Through face-to-face, virtual interdisciplinary educational actions (B-learning) and with simulation support. |
| Usual Care | No intervention | –The people assigned to this group will receive their own responses from the institution providing care services to which they belong. These instructions consist of: information on the disease process and treatment received from the medical group, information on assistance by the nursing group and finally, the administrative procedures carried out by social work. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Caregivers aged 18 years or older.
- Be related to the person with cardiocerebrovascular disease in a condition of moderate to severe disability according to the Barthel scale.
- Having assumed the care of the person with a chronic illness in a condition of disability for a period greater than three months. (Note: if there is more than one family caregiver, the caregiver who has the longest stay in care and assistance will be selected).
- Know how to read and write.
- Have computer equipment and internet connectivity and a telephone
Key exclusion criteria (2 listed)
- Family caregivers with cognitive and / or behavioral impairment that prevents them from participating in the research.
- Family caregivers of disabled people with cardiocerebrovascular disease, who are participating in other studies related to the topic of the research process.
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 |
|---|---|---|
| Intervention group: Educational Intervention "KARER"Also: Educational Intervention "Karer"Multicomponent and interdisciplinary intervention on the care ability and burden of family caregivers. It consists of: Virtual componet * Module 0: the introduction * Module 1: called "Identifying my role as a caregiver" * Module 2: called "Strategies to strengthen care" * Module 3: called "Strengthening my caring skills" Face-to-face componed - Two seasons of 4 hours each Simulation component - One season of practices abilities of 4 hours. | Behavioural | Intervention group: Educational Intervention "KARER" |
Primary outcome
Changes of mean score ability from baseline at 2 months
Time frame: baseline at 2 months
It will measure with the "Caring Ability Inventory" (CAI): This instrument is composed of 37 items with a Likert-type graduation from 1 to 7, which are distributed in three subscales: knowledge, with 14 items, corage with 13 items, and patience with 10 items. The total score ranges from 37 to 259 points and the care ability is considered as: low (<203.1), medium (203.1 to 220.3), high (> 220.3).
Changes of mean score of burden caregivers from baseline at 2 months
Time frame: baseline at 2 months
It will measure with the "Zarit Burden Interview", The Zarit scale score ranges from 22 to 110 points and the caregiver burden is considered as: no burden (<or equal to 46), light burden (47 to 55), or heavy burden (> or equal to 56)
1 secondary outcome
Qualitative results: perception about caring ability and burden caregivers
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- BackgroundNkongho, N. O. (2003). The caring ability inventory. Measurement of nursing outcomes, 3, 184-198
- Background: PubMed 28453089Carrillo G GM, Sanchez-Herrera B, Barrera-Ortiz L. [Caring ability of family caregivers of children with cancer]. Rev Salud Publica (Bogota). 2015 May;17(3):394-403. doi: 10.15446/rsap.v17n3.32408. Spanish.
- Background: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- EQ-5D User GuidesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Manuscript, Scientific Congress's, Share the results with the participants at the end of the research
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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.
Henry M Puerto Pedraza, RNs, MSc. principal investigator
Fundación Universitaria Sanitas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group: Educational Intervention "KARER" in people with Caregivers and Burnout, Psychological, run by Claudia Aristizábal at 3 sites 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 7 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of mean score ability from baseline at 2 months (time frame: baseline at 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645290, which also lists 3 linked publications.
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 14 Oct 2021.