Caregiver BurnoutNCT04993248
"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
A study testing Dialog Circle in people with Caregiver Burnout, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The increase in life expectancy and the decrease in the birth rate have led to an aging population and a higher prevalence of chronic diseases. This has generated the need for informal caregivers of older adults to face health care situations of this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Dialog Circle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Primary caregivers of patients identified as Patient Chronic and/or advanced chronic disease who are in the case management service portfolio in the basic areas of SAP Baix Llobregat Centre and Delta de Llobregat.
- Primary caregivers with the abbreviated caregiver burden scale administered.
Who cannot join
- Caregivers under 18 years of age.
- Occasional caregivers.
- Professional or contracted caregivers.
- Primary caregivers of patients diagnosed with any type of dementia.
- Primary caregivers participating at the time of the intervention in some type of individual or group psychological intervention.
- Not wishing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jose Manuel Tinoco Camarena
L'Hospitalet de Llobregat, Barcelona, 08907
Jose Manuel T Camarena, 661345110, Josetinococamarena@gmail.com
About this study
Official title: Nursing Intervention "Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
The increase in life expectancy and the decrease in the birth rate have led to an aging population and a higher prevalence of chronic diseases. This has generated the need for informal caregivers of older adults to face health care situations of this population. On the other hand, it has become evident how the epidemiological profile has changed over the last 50 years, with a decrease in infectious diseases and a higher prevalence of chronic non-communicable diseases, which increase the demand for family caregivers. Caring for a dependent family member can negatively affect the caregiver's health in his or her affective and working life. In the first phase, a cross-sectional descriptive study will be carried out and in the second phase, an experimental study, randomized clinical trial (RCT) with simple masking will be conducted Objectives: Phase I general objective is to describe the sociodemographic characteristics of the study sample. Specific in this phase are to analyze the relationship between level of caregiver strain and sociodemographic variables collected from primary caregivers, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living. To analyze the relationship between level of caregiver overload and deterioration in the patient's cognitive sphere. To analyze the relationship between overload and the instrumental activities that the patient can perform. To analyze the relationship between overload and mental health from a positive perspective. Phase II: the general objective is to determine the efficacy of the nursing intervention, dialogue circles, to reduce the level of overload perceived by caregivers of patients identified as complex chronic patients and chronic advanced disease. The specific objectives are to compare the level of overload perceived by the main caregivers before and after the intervention between the experimental group and the control group, and the degree of satisfaction with the dialogue circles nursing intervention. It will be carried out in Catalonia, in the populations of the metropolitan area of Barcelona, belonging to the Primary Care Service (SAP) Baix Llobregat Centre.
- Conditions
- Caregiver Burnout
- Being tested
- Dialog Circle
- Keywords
- Informal caregiver, Overload, Nurse
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialog CircleOther
The intervention will offer participants the opportunity to share feelings and needs with people who are in a similar situation to their own.
Each intervention consists of 3 dialogue circles per group. Each group is composed of 10 participants and a facilitator, in all interventions the facilitator will be the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will offer participants the opportunity to share feelings and needs with people who are in a similar situation to their own.
Each intervention consists of 3 dialogue circles per group. Each group is composed of 10 participants and a facilitator, in all interventions the facilitator will be the principal investigator. Receives: Other: Dialog Circle |
| Control | No intervention | Usual intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overload caregivers
Short Interview on burden of care for caregivers in primary care
Measured: Changes in the level of overload (Pre intervention and 15 days after nursing intervention )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jan 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurnoutStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Manuel Camarena, Principal investigator, Idiap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993248
- Sponsor's protocol ID
- 20/112-PCV
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carreño SP, Sánchez-Herrera B, Carrillo GM, Chaparro-Díaz L, Gómez OJ. Carga de la enfermedad crónica para los sujetos implicados en el cuidado. Rev. Fac. Nac. Salud Pública 2016; 34(3): 342-349.
Martín M, Salvadó I, Nadal S, Miji LC, Rico JM, Lanz P. Adaptación para nuestro medio de la escala de sobrecarga del cuidador (Caregiver Burden Interview) de Zarit. Rev Gerontol. 1996; 6:338-46.
3. Sánchez Martínez RT, Molina Cardona EM,Gómez-Ortega OR. Intervenciones de enfermería para disminuir la sobrecarga en cuidadores: un estudio piloto. Revista Cuidarte. 2016; 7(1):1171-84.
Herbert R, Bravo G, Preville M. Reliability, validity and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia. Can J Aging 2000;19:494-507. http://dx.doi.org/10.1017/S0714980800012484
Taub A, Andreoli SB, Bertolucci PH. Dementia caregiver burden: reliability of the Brazilian version of the Zarit caregiver burden interview. Cad Saude Publica. 2004 Mar-Apr;20(2):372-6. doi: 10.1590/s0102-311x2004000200004. Epub 2004 Apr 6.
PubMed 15073616Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.
PubMed 15717336Velez Lopera JM, Berbesi Fernandez D, Cardona Arango D, Segura Cardona A, Ordonez Molina J. [Validation of the abbreviated Zarit scales for measuring burden syndrome in the primary caregiver of an elderly patient]. Aten Primaria. 2012 Jul;44(7):411-6. doi: 10.1016/j.aprim.2011.09.007. Epub 2011 Nov 4. Spanish.
PubMed 22055916Arai Y, Kudo K, Hosokawa T, Washio M, Miura H, Hisamichi S. Reliability and validity of the Japanese version of the Zarit Caregiver Burden interview. Psychiatry Clin Neurosci. 1997 Oct;51(5):281-7. doi: 10.1111/j.1440-1819.1997.tb03199.x.
PubMed 9413874
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention "Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
- ClinicalTrials.gov ID
- NCT04993248
- Acronym / sponsor ID
- 20/112-PCV
- Conditions
- Caregiver Burnout
- Keywords
- Informal caregiver, Overload, Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 6 Aug 2021 (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 increase in life expectancy and the decrease in the birth rate have led to an aging population and a higher prevalence of chronic diseases. This has generated the need for informal caregivers of older adults to face health care situations of this population. On the other hand, it has become evident how the epidemiological profile has changed over the last 50 years, with a decrease in infectious diseases and a higher prevalence of chronic non-communicable diseases, which increase the demand for family caregivers. Caring for a dependent family member can negatively affect the caregiver's health in his or her affective and working life. In the first phase, a cross-sectional descriptive study will be carried out and in the second phase, an experimental study, randomized clinical trial (RCT) with simple masking will be conducted Objectives: Phase I general objective is to describe the sociodemographic characteristics of the study sample. Specific in this phase are to analyze the relationship between level of caregiver strain and sociodemographic variables collected from primary caregivers, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living. To analyze the relationship between level of caregiver overload and deterioration in the patient's cognitive sphere. To analyze the relationship between overload and the instrumental activities that the patient can perform. To analyze the relationship between overload and mental health from a positive perspective. Phase II: the general objective is to determine the efficacy of the nursing intervention, dialogue circles, to reduce the level of overload perceived by caregivers of patients identified as complex chronic patients and chronic advanced disease. The specific objectives are to compare the level of overload perceived by the main caregivers before and after the intervention between the experimental group and the control group, and the degree of satisfaction with the dialogue circles nursing intervention. It will be carried out in Catalonia, in the populations of the metropolitan area of Barcelona, belonging to the Primary Care Service (SAP) Baix Llobregat Centre.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dialog CircleThe intervention will offer participants the opportunity to share feelings and needs with people who are in a similar situation to their own. Each intervention consists of 3 dialogue circles per group. Each group is composed of 10 participants and a facilitator, in all interventions the facilitator will be the principal investigator. |
| Control | No intervention | –Usual intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Primary caregivers of patients identified as Patient Chronic and/or advanced chronic disease who are in the case management service portfolio in the basic areas of SAP Baix Llobregat Centre and Delta de Llobregat.
- Primary caregivers with the abbreviated caregiver burden scale administered.
Key exclusion criteria (6 listed)
- Caregivers under 18 years of age.
- Occasional caregivers.
- Professional or contracted caregivers.
- Primary caregivers of patients diagnosed with any type of dementia.
- Primary caregivers participating at the time of the intervention in some type of individual or group psychological intervention.
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 |
|---|---|---|
| Dialog CircleThe intervention will offer participants the opportunity to share feelings and needs with people who are in a similar situation to their own. Each intervention consists of 3 dialogue circles per group. Each group is composed of 10 participants and a facilitator, in all interventions the facilitator will be the principal investigator. | Other | Intervention |
Primary outcome
Overload caregivers
Time frame: Changes in the level of overload (Pre intervention and 15 days after nursing intervention )
Short Interview on burden of care for caregivers in primary care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- BackgroundCarreño SP, Sánchez-Herrera B, Carrillo GM, Chaparro-Díaz L, Gómez OJ. Carga de la enfermedad crónica para los sujetos implicados en el cuidado. Rev. Fac. Nac. Salud Pública 2016; 34(3): 342-349.
- BackgroundMartín M, Salvadó I, Nadal S, Miji LC, Rico JM, Lanz P. Adaptación para nuestro medio de la escala de sobrecarga del cuidador (Caregiver Burden Interview) de Zarit. Rev Gerontol. 1996; 6:338-46.
- Background3. Sánchez Martínez RT, Molina Cardona EM,Gómez-Ortega OR. Intervenciones de enfermería para disminuir la sobrecarga en cuidadores: un estudio piloto. Revista Cuidarte. 2016; 7(1):1171-84.
- BackgroundHerbert R, Bravo G, Preville M. Reliability, validity and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia. Can J Aging 2000;19:494-507. http://dx.doi.org/10.1017/S0714980800012484
- Background: PubMed 15073616Taub A, Andreoli SB, Bertolucci PH. Dementia caregiver burden: reliability of the Brazilian version of the Zarit caregiver burden interview. Cad Saude Publica. 2004 Mar-Apr;20(2):372-6. doi: 10.1590/s0102-311x2004000200004. Epub 2004 Apr 6.
- Results publication: PubMed 15717336Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.
- Results publication: PubMed 22055916Velez Lopera JM, Berbesi Fernandez D, Cardona Arango D, Segura Cardona A, Ordonez Molina J. [Validation of the abbreviated Zarit scales for measuring burden syndrome in the primary caregiver of an elderly patient]. Aten Primaria. 2012 Jul;44(7):411-6. doi: 10.1016/j.aprim.2011.09.007. Epub 2011 Nov 4. Spanish.
- Results publication: PubMed 9413874Arai Y, Kudo K, Hosokawa T, Washio M, Miura H, Hisamichi S. Reliability and validity of the Japanese version of the Zarit Caregiver Burden interview. Psychiatry Clin Neurosci. 1997 Oct;51(5):281-7. doi: 10.1111/j.1440-1819.1997.tb03199.x.
- 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.
Jose Manuel Camarena principal investigator
Idiap
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialog Circle in people with Caregiver Burnout, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 2 inclusion and 6 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 5 May 2022. 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 Spain. 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 Jose Manuel Tinoco Camarena (661345110, Josetinococamarena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overload caregivers (time frame: Changes in the level of overload (Pre intervention and 15 days after nursing intervention )). 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 NCT04993248, which also lists 8 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 5 May 2022.