"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
Primary Purpose
Caregiver Burnout
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dialog Circle
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burnout focused on measuring Informal caregiver, Overload, Nurse
Eligibility Criteria
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Jose Manuel Tinoco CamarenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Usual intervention
Outcomes
Primary Outcome Measures
Overload caregivers
Short Interview on burden of care for caregivers in primary care
Secondary Outcome Measures
Full Information
NCT ID
NCT04993248
First Posted
July 13, 2021
Last Updated
May 4, 2022
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1. Study Identification
Unique Protocol Identification Number
NCT04993248
Brief Title
"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
Official Title
Nursing Intervention "Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
Keywords
Informal caregiver, Overload, Nurse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Participant
Masking Description
Single masking
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual intervention
Intervention Type
Other
Intervention Name(s)
Dialog Circle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overload caregivers
Description
Short Interview on burden of care for caregivers in primary care
Time Frame
Changes in the level of overload (Pre intervention and 15 days after nursing intervention )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Manuel Tinoco Camarena
Phone
661345110
Email
Josetinococamarena@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Manuel Camarena
Phone
661345110
Email
Josetinococamarena@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Camarena
Organizational Affiliation
Idiap
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Manuel Tinoco Camarena
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Manuel T Camarena
Phone
661345110
Email
Josetinococamarena@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
15073616
Citation
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.
Results Reference
background
PubMed Identifier
15717336
Citation
Ankri 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 Reference
result
PubMed Identifier
22055916
Citation
Velez 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 Reference
result
PubMed Identifier
9413874
Citation
Arai 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.
Results Reference
result
Learn more about this trial
"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
We'll reach out to this number within 24 hrs