Effectiveness of Nursing Intervention on Caregivers

NCT ID: NCT01478295

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

Brief 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.

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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CuidaCare Intervention

Intervention Type: BEHAVIORAL

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

Control Group/Usual Care:

Intervention Type: OTHER

Control Group/Usual Care:

Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

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.

Group Type: ACTIVE_COMPARATOR

Control Group/Usual Care:

Intervention Type: OTHER

Control Group/Usual Care:

Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Interventions

CuidaCare Intervention

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

Intervention Type: BEHAVIORAL

Control Group/Usual Care:

Control Group/Usual Care:

Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Intervention Type: OTHER

Other Intervention Names

Nursing intervention; Primary Health care; Caregiver; Strain; Quality of life; Standardized care plan (PCE)

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Milagros Rico Blazquez

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milagros Rico, Nurse

Role: PRINCIPAL_INVESTIGATOR

Gerencia Atención Primaria. Madrid

Locations

Gerencia Atención Primaria, Madrid

Madrid, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 24467767 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35351100 (View on PubMed)

Other Identifiers

FIS PI11/02132

Identifier Type: -

Identifier Source: org_study_id