Effectiveness of Nursing Intervention on Caregivers

NCT01478295 | Completed DMC

• 1 other identifier: FIS PI11/02132
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Nursing intervention; Primary Health care; caregiver; strain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nursing diagnosis

  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

• Depression scale

  Change from Baseline in Depression scale at 18 months after the intervention

• Anxiety level

  Change from Baseline in Anxiety level at 18 months after the intervention

• Family function

  Change from Baseline in Family function at 18 months after the intervention

Study Arms (2)

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

Behavioral: CuidaCare Intervention; Other: Control Group/Usual Care:

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.

Other: Control Group/Usual Care:

Interventions

CuidaCare Intervention BEHAVIORAL

Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Also known as: Nursing intervention, Primary Health care, Caregiver, Strain, Quality of life, Standardized care plan (PCE)

CuidaCare Intervention

Control Group/Usual Care: OTHER

Control Group/Usual Care: Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Control Group/Usual Care; CuidaCare Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Gerencia Atención Primaria, Madrid

Madrid, Madrid, 28003, Spain

Location

Related Publications (2)

• 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.

  PMID: 24467767 BACKGROUND

• 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.

  PMID: 35351100 DERIVED

MeSH Terms

Conditions

Sprains and Strains

Interventions

Methods; Primary Health Care; Caregivers; Quality of Life; Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques; Comprehensive Health Care; Patient Care Management; Health Services Administration; Health Personnel; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Epidemiologic Research Design; Epidemiologic Methods; Research Design

Study Officials

• Milagros Rico, Nurse

  Gerencia Atención Primaria. Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 23, 2011
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

ES (1)