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Completed

NCT Number: NCT01478295

Effectiveness of Nursing Intervention on Caregivers

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.

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Key information

Conditions

Quality of Life Sprains and Strains Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia Atención Primaria, Madrid

Madrid, 28003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CuidaCare Intervention

Behavioral

Nursing intervention address to Caregiver 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, Standardized care plan (PCE)

Control Group/Usual Care:

Other

Control Group/Usual Care:

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

Primary outcomes

  1. Perceived quality of life

    Time frame: Change from baseline in quality of life at 18 months after the intervention

    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 outcomes

  1. Nursing diagnosis

    Time frame: Change from Baseline in Nursing diagnosis at 18 months after the intervention

    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

  2. Caregiver Burden

    Time frame: Change from Baseline in Caregiver Burden at 18 months after the intervention

    Zarit Caregiver Burden Interview. Change from Baseline in Nursing diagnosis at 18 months after the intervention.

  3. Depression scale

    Time frame: Change from Baseline in Depression scale at 18 months after the intervention

    Yesavage Depression scale. Change from Baseline in Depression scale at 18 months of the intervention.

  4. Anxiety level

    Time frame: Change from Baseline in Anxiety level at 18 months after the intervention

    Goldberg scale. Change from Baseline in Anxiety level at 18 months after the intervention

  5. Family function

    Time frame: Change from Baseline in Family function at 18 months after the intervention

    Family Apgar test. Change from Baseline in Family function at 18 months after the intervention

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: CuidaCare

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 23, 2011
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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