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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
266
Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
Gerencia Atención Primaria, Madrid
Madrid, Madrid, Spain
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
Time frame: Change from baseline in quality of life at 18 months after the intervention
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Change from Baseline in Family function at 18 months after the intervention
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