Effectiveness of Nursing Intervention on Caregivers

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Behavioral: CuidaCare Intervention

• Registration Number: NCT01478295
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Study Start: 2013-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CuidaCare Intervention	CuidaCare Intervention	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

Primary Outcome Measures

Name	Time	Method
Perceived quality of life	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 Outcome Measures

Name	Time	Method
Nursing diagnosis	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
Caregiver Burden	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.
Depression scale	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.
Family function	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
Anxiety level	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

Trial Locations

Locations (1)

Gerencia Atención Primaria, Madrid; 🇪🇸 Madrid, Spain