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Quality of LifeCuidaCareNCT01478295

Effectiveness of Nursing Intervention on Caregivers

A study testing CuidaCare Intervention in people with Quality of Life, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Quality of Life
What is being tested?
CuidaCare Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteSpain
Study dates
Jun 2013to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Gerencia Atención Primaria, Madrid

    Madrid, Madrid, 28003

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Quality of Life
Being tested
CuidaCare Intervention, Control Group/Usual Care:
Keywords
Nursing intervention, Primary Health care, caregiver, strain
Medical subject headings
Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CuidaCare InterventionBehavioural

    Also called Nursing intervention, Primary Health care, Caregiver, Strain

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

  • Control Group/Usual Care:Other

    Control Group/Usual Care:

    Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education

Study groups in NCT01478295
Study groupRoleWhat they receive
CuidaCare InterventionExperimentalRegular 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
Receives: Behavioral: CuidaCare Intervention; Other: Control Group/Usual Care:
Control Group/Usual CareActive comparatorUsual 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.
Receives: Other: Control Group/Usual Care:

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change from baseline in quality of life at 18 months after the intervention

Secondary outcomes (5)

  1. 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

    Measured: Change from Baseline in Nursing diagnosis at 18 months after the intervention

  2. Caregiver Burden

    Zarit Caregiver Burden Interview. Change from Baseline in Nursing diagnosis at 18 months after the intervention.

    Measured: Change from Baseline in Caregiver Burden at 18 months after the intervention

  3. Depression scale

    Yesavage Depression scale. Change from Baseline in Depression scale at 18 months of the intervention.

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

  4. Anxiety level

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

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

  5. Family function

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2011 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01478295
Sponsor's protocol ID
FIS PI11/02132
Acronym
CuidaCare
Status last verified
Feb 2016
First submitted
15 Nov 2011
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24467767

  • 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.

    PubMed 35351100

Questions about this trial

What is this clinical trial studying?

A study testing CuidaCare Intervention in people with Quality of Life, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived quality of life (time frame: Change from baseline in quality of life at 18 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01478295, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.

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