Effectiveness of Nursing Intervention on Caregivers

Quality of Life Clinical Trial

— CuidaCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478295
• Other study ID #: FIS PI11/02132
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: February 10, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• CuidaCare Intervention
Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Other:
• Control Group/Usual Care:
Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Locations

Country	Name	City	State
Spain	Gerencia Atención Primaria, Madrid	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Rico-Blázquez M, Escortell-Mayor E, Del-Cura-González I, Sanz-Cuesta T, Gallego-Berciano P, de Las Casas-Cámara G, Soto-Díaz S, García-Sanz P, Harris-de-la-Vega N, Martín-Martín M, Domínguez-Pérez L, Rivera-Álvarez A, Sarrión-Bravo JA, Pérez-de-Hita C, de-Frías-Redondo M, Ferrer-Arnedo C, Hernández-Pascual M, Valdivia-Pérez A, Fariña 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No