Effectiveness of Nursing Intervention on Caregivers (CuidaCare)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Gerencia de Atención Primaria, Madrid
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01478295
First received: November 15, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Quality of Life
Behavioral: Standardized care plan (PCE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Perceived quality of life [ Time Frame: Change from baseline in quality of life at 18 months after the intervention ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Nursing diagnosis [ Time Frame: Change from Baseline in Nursing diagnosis at 18 months after the intervention ] [ Designated as safety issue: No ]

    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


  • Caregiver Burden [ Time Frame: Change from Baseline in Caregiver Burden at 18 months after the intervention ] [ Designated as safety issue: No ]
    Zarit Caregiver Burden Interview. Change from Baseline in Nursing diagnosis at 18 months after the intervention.

  • Depression scale [ Time Frame: Change from Baseline in Depression scale at 18 months after the intervention ] [ Designated as safety issue: No ]
    Yesavage Depression scale. Change from Baseline in Depression scale at 18 months of the intervention.

  • Anxiety level [ Time Frame: Change from Baseline in Anxiety level at 18 months after the intervention ] [ Designated as safety issue: No ]
    Goldberg scale. Change from Baseline in Anxiety level at 18 months after the intervention

  • Family function [ Time Frame: Change from Baseline in Family function at 18 months after the intervention ] [ Designated as safety issue: No ]
    Family Apgar test. Change from Baseline in Family function at 18 months after the intervention


Estimated Enrollment: 142
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CuidaCare
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: Standardized care plan (PCE)

Standardized care plan (PCE):

Coping strategies promoting social support and empowerment through health education

Other Names:
  • Nursing intervention
  • Primary Health care
  • Caregiver
  • Strain
  • Quality of life
Control Group
Regular 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.
Behavioral: Standardized care plan (PCE)

Standardized care plan (PCE):

Coping strategies promoting social support and empowerment through health education

Other Names:
  • Nursing intervention
  • Primary Health care
  • Caregiver
  • Strain
  • Quality of life

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478295

Contacts
Contact: Milagros Rico, Nurse +34 91 335 25 69 ext 353 milagros.rico@salud.madrid.org
Contact: Esperanza Escortell, MD +34 91 335 25 69 ext 380 eescortell.gapm03@salud.madrid.org

Locations
Spain
Gerencia Atención Primaria, Madrid Not yet recruiting
Madrid, Spain, 28003
Principal Investigator: Milagros Rico, Nurse         
Sub-Investigator: Esperanza Escortell, MD         
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Milagros Rico, Nurse Gerencia Atención Primaria. Madrid
  More Information

No publications provided

Responsible Party: Esperanza Escortell, Epidemiologist, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01478295     History of Changes
Other Study ID Numbers: FIS PI11/02132
Study First Received: November 15, 2011
Last Updated: April 4, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Gerencia de Atención Primaria, Madrid:
Nursing intervention
Primary Health care
caregiver
strain

ClinicalTrials.gov processed this record on August 20, 2014