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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fondo de Investigacion Sanitaria | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CuidaCare Intervention | Experimental | 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 |
|
| Control Group/Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CuidaCare Intervention | Behavioral | Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milagros Rico, Nurse | Gerencia Atención Primaria. Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia Atención Primaria, Madrid | Madrid | Madrid | 28003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24467767 | Background | Rico-Blazquez M, Escortell-Mayor E, Del-Cura-Gonzalez I, Sanz-Cuesta T, Gallego-Berciano P, de Las Casas-Camara G, Soto-Diaz S, Garcia-Sanz P, Harris-de-la-Vega N, Martin-Martin M, Dominguez-Perez L, Rivera-Alvarez A, Sarrion-Bravo JA, Perez-de-Hita C, de-Frias-Redondo M, Ferrer-Arnedo C, Hernandez-Pascual M, Valdivia-Perez A, Farina YR. CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial. BMC Nurs. 2014 Jan 27;13(1):2. doi: 10.1186/1472-6955-13-2. | |
| 35351100 |
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D011320 | Primary Health Care |
| D017028 | Caregivers |
| D011788 | Quality of Life |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
| Control Group/Usual Care: | Other | Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education |
|
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 |
| Derived |
| Rico-Blazquez M, Quesada-Cubo V, Polentinos-Castro E, Sanchez-Ruano R, Rayo-Gomez MA, Del Cura-Gonzalez I; CuidaCare Group. Health-related quality of life in caregivers of community-dwelling individuals with disabilities or chronic conditions. A gender-differentiated analysis in a cross-sectional study. BMC Nurs. 2022 Mar 29;21(1):69. doi: 10.1186/s12912-022-00845-x. |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |