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

November 15, 2011
April 4, 2013
June 2013
December 2014   (final data collection date for primary outcome measure)
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
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 6 months, 12 months and 18 months after the intervention
Complete list of historical versions of study NCT01478295 on ClinicalTrials.gov Archive Site
  • 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
  • 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 6 months, 12 months and 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 6 months, 12 months and 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 6 months, 12 months and 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 6 months, 12 months and 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 6 months, 12 months and 18 months after the intervention
Not Provided
Not Provided
 
Effectiveness of Nursing Intervention on Caregivers
Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Quality of Life
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
  • 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
    Intervention: Behavioral: Standardized care plan (PCE)
  • 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.
    Intervention: Behavioral: Standardized care plan (PCE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
142
June 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
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
Spain
 
NCT01478295
FIS PI11/02132
Yes
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
Gerencia de Atención Primaria, Madrid
  • Instituto de Salud Carlos III
  • Fondo de Investigacion Sanitaria
Principal Investigator: Milagros Rico, Nurse Gerencia Atención Primaria. Madrid
Gerencia de Atención Primaria, Madrid
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP