Clinical trial NCT04993248: "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
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Burnout
Keywords: Informal caregiver
Overload
Nurse
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Overload caregivers
timeFrame: Changes in the level of overload (Pre intervention and 15 days after nursing intervention )
Secondary outcomes:
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Jose Manuel Tinoco Camarena
state: Barcelona
Study officials:
affiliation: Idiap
name: Jose Manuel Camarena
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.