Clinical trial NCT01478295: Effectiveness of Nursing Intervention on Caregivers
Official title: Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Nursing intervention
Primary Health care
caregiver
strain
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Fondo de Investigacion Sanitaria
First posted: 2011-11-23
Enrollment: 266
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived quality of life
timeFrame: Change from baseline in quality of life at 18 months after the intervention
Secondary outcomes:
measure: Nursing diagnosis
timeFrame: Change from Baseline in Nursing diagnosis at 18 months after the intervention
measure: Caregiver Burden
timeFrame: Change from Baseline in Caregiver Burden at 18 months after the intervention
measure: Depression scale
timeFrame: Change from Baseline in Depression scale at 18 months after the intervention
measure: Anxiety level
timeFrame: Change from Baseline in Anxiety level at 18 months after the intervention
measure: Family function
timeFrame: Change from Baseline in Family function at 18 months after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia Atención Primaria, Madrid
Study officials:
affiliation: Gerencia Atención Primaria. Madrid
name: Milagros Rico, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.