"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease

Sponsor
Jordi Gol i Gurina Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04993248
Collaborator
(none)
80
1
2
30
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dialog Circle
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trialRandomized clinical trial
Masking:
Single (Participant)
Masking Description:
Single masking
Primary Purpose:
Supportive Care
Official Title:
Nursing Intervention "Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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.

Other: Dialog Circle
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.

No Intervention: Control

Usual intervention

Outcome Measures

Primary Outcome Measures

  1. Overload caregivers [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jose Manuel Tinoco Camarena Hospitalet de Llobregat Barcelona Spain 08907

Sponsors and Collaborators

  • Jordi Gol i Gurina Foundation

Investigators

  • Principal Investigator: Jose Manuel Camarena, Idiap

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT04993248
Other Study ID Numbers:
  • 20/112-PCV
First Posted:
Aug 6, 2021
Last Update Posted:
May 5, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jordi Gol i Gurina Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022