Effectiveness of Nursing Intervention on Caregivers (CuidaCare)

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Quality of Life

Treatments: Behavioral: CuidaCare Intervention; Other: Control Group/Usual Care:

Study type: Interventional

Funder types: Other

Identifiers

NCT01478295

FIS PI11/02132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

CuidaCare Intervention

Experimental group

Description:

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

Treatment:

Other: Control Group/Usual Care:

Behavioral: CuidaCare Intervention

Control Group/Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Control Group/Usual Care: