Effectiveness of Nursing Intervention on Caregivers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Quality of Life

Intervention / Treatment
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* Behavioral: CuidaCare Intervention
* Other: Control Group/Usual Care:


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CuidaCare Intervention<br>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: CuidaCare Intervention<br>* Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education<br>* Other names: Standardized care plan (PCE);Other: Control Group/Usual Care:<br>* Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education<br>|
| Active Comparator: Control Group/Usual Care<br>Usual 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. | Other: Control Group/Usual Care:<br>* Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived quality of life | 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 | Change from baseline in quality of life at 18 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nursing diagnosis | 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 | Change from Baseline in Nursing diagnosis at 18 months after the intervention | 
| Caregiver Burden | Zarit Caregiver Burden Interview. Change from Baseline in Nursing diagnosis at 18 months after the intervention. | Change from Baseline in Caregiver Burden at 18 months after the intervention | 
| Depression scale | Yesavage Depression scale. Change from Baseline in Depression scale at 18 months of the intervention. | Change from Baseline in Depression scale at 18 months after the intervention | 
| Anxiety level | Goldberg scale. Change from Baseline in Anxiety level at 18 months after the intervention | Change from Baseline in Anxiety level at 18 months after the intervention | 
| Family function | Family Apgar test. Change from Baseline in Family function at 18 months after the intervention | Change from Baseline in Family function at 18 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing intervention, Primary Health care, caregiver, strain