Effectiveness of Nursing Intervention on Caregivers (CuidaCare)

Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters

The purpose of this study is to evaluate the effectiveness of a structured nursing intervention (PCE), including two types of intervention defined in the literature (coping strategies promoting social support and empowerment through health education), which has an effect on the perceived quality of life for the caregiver, when compared with conventional intervention or non-support.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: CuidaCare Intervention; Other: Control Group/Usual Care:

Detailed Description

Aim: to compare the effectiveness of a standardized care plan (SCP) compared to the usual nursing intervention to improve the quality of life for primary caregivers over 65 years old measured through points change with the EuroQol-5D (EQ-5D) scale.

Secondary objectives:

Evaluate the influence of prognostic variables on quality of life of caregiver. Describe the level of caregiver burden. Describe the socio-demographic profile of the dependent person and caregiver.

Method:

Design: cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. Subjects: unit of randomization: primary healthcare centres. Analysis unit: caregivers over 65 years old.

Intervention: The SCP in the treatment group and the usual intervention in the control group.

Sample size adjusted for design effect= 218 (109 in each arm). Main response variable: perceived quality of life (EQ-5D). Secondary response variables: nursing diagnosis, Zarit Caregiver Burden Interview, objective overload level.

Prognostic variables:Dependent person-related: dependence level (Barthel, Lawton-Brody), cognitive dysfunction (Pfeiffer).

Caregiver-related: depression scale (Yesavage), anxiety level (Goldberg), family function (family Apgar). Sociodemographic variables.

Data Analysis: Analysis of main effectiveness by intention to treat, comparing the difference in units on the EQ-5D scale before and post- intervention in both groups at 0, 6, 12 and 18 months. The estimation adjusted, using logistic regression with aleatory effects, those data that can act as confounding factors or change the effect.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28003
    • Gerencia Atención Primaria, Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Not psychological treatment or social support during the study period.
• Be able to follow the trial's demands.
• Experience of caring for at least 6 months in a year.
• Caregivers who consent to take part.

Exclusion Criteria:

• Caregivers of patients hospitalized during the initial data collection.
• Caregivers of institutionalized patients.
• Severe psychiatric conditions including depression and major affective pictures.
• Paid caregivers.
• Experience as a caregiver for less than a month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CuidaCare Intervention; Regular care in consultation or home and Structured nursing care (CuidaCare intervention): improved strategies for coping, health education on self-care and dependent care and emotional support. 10 visits are structured, with a periodicity of approximately 2 visits per month and last for 30 to 40 minutes each	Behavioral: CuidaCare Intervention; Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education; Other Names: Quality of life; Nursing intervention; Primary Health care; Caregiver; Strain; Standardized care plan (PCE); Other: Control Group/Usual Care: Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
ACTIVE_COMPARATOR: Control Group/Usual Care; Usual care in consultation or home, which is to respond to the specific demands of care of the caregiver, using the resources of the nursing discipline.	Other: Control Group/Usual Care: Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived quality of life	Perceived quality of life: Quality of life measured by EuroQol (EQ5D) Scale Change from baseline in quality of life at 18 months after the intervention	Change from baseline in quality of life at 18 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nursing diagnosis	Use NANDA International Classification to measure: caregiver role strain or caregiver role (risk for) or stress(overload). Change from Baseline in Nursing diagnosis at 18 months after the intervention	Change from Baseline in Nursing diagnosis at 18 months after the intervention
Caregiver Burden	Zarit Caregiver Burden Interview. Change from Baseline in Nursing diagnosis at 18 months after the intervention.	Change from Baseline in Caregiver Burden at 18 months after the intervention
Depression scale	Yesavage Depression scale. Change from Baseline in Depression scale at 18 months of the intervention.	Change from Baseline in Depression scale at 18 months after the intervention
Anxiety level	Goldberg scale. Change from Baseline in Anxiety level at 18 months after the intervention	Change from Baseline in Anxiety level at 18 months after the intervention
Family function	Family Apgar test. Change from Baseline in Family function at 18 months after the intervention	Change from Baseline in Family function at 18 months after the intervention

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Fondo de Investigacion Sanitaria; Instituto de Salud Carlos III
• Investigators: Principal Investigator: Milagros Rico, Nurse, Gerencia Atención Primaria. Madrid

Publications and helpful links

General Publications

• Rico-Blazquez M, Escortell-Mayor E, Del-Cura-Gonzalez I, Sanz-Cuesta T, Gallego-Berciano P, de Las Casas-Camara G, Soto-Diaz S, Garcia-Sanz P, Harris-de-la-Vega N, Martin-Martin M, Dominguez-Perez L, Rivera-Alvarez A, Sarrion-Bravo JA, Perez-de-Hita C, de-Frias-Redondo M, Ferrer-Arnedo C, Hernandez-Pascual M, Valdivia-Perez A, Farina YR. CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial. BMC Nurs. 2014 Jan 27;13(1):2. doi: 10.1186/1472-6955-13-2.
• Rico-Blazquez M, Quesada-Cubo V, Polentinos-Castro E, Sanchez-Ruano R, Rayo-Gomez MA, Del Cura-Gonzalez I; CuidaCare Group. Health-related quality of life in caregivers of community-dwelling individuals with disabilities or chronic conditions. A gender-differentiated analysis in a cross-sectional study. BMC Nurs. 2022 Mar 29;21(1):69. doi: 10.1186/s12912-022-00845-x.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (ESTIMATE): November 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: caregiver; strain; Nursing intervention; Primary Health care
• Other Study ID Numbers: FIS PI11/02132