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Effectiveness of Nursing Intervention on Caregivers

Information source: Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Quality of Life

Intervention: Standardized care plan (PCE) (Behavioral)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Gerencia de Atención Primaria, Madrid

Official(s) and/or principal investigator(s):
Milagros Rico, Nurse, Principal Investigator, Affiliation: Gerencia Atención Primaria. Madrid


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.

Clinical Details

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

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

Primary outcome: Perceived quality of life

Secondary outcome:

Nursing diagnosis

Caregiver Burden

Depression scale

Anxiety level

Family function

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.


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Gerencia Atención Primaria, Madrid, Madrid 28003, Spain
Additional Information

Starting date: June 2013
Last updated: April 21, 2015

Page last updated: August 23, 2015

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