Person Centered Nursing Homes: Impact Assessment Of Centered Person Care In Nursing Homes (RECENPE)

June 26, 2017 updated by: Fundacio Salut i Envelliment UAB

Residències Centrades en Les Persones (RECENPE): avaluació de l'Impacte d'un Model d'ACP en residències Per Persones Grans

Cohort Observational Study. The study will assess differences in quality of life, well-being and mood between persons living in a nursing home following usual care and persons living in nursing homes following a centered person care model.

Initially, the follow up will last 6 months, with the possibility to be extended.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • Sant Sadurní d'Anoia, Barcelona, Spain, 08770
        • Residència "Casa del Avis"
    • Girona
      • Sant Hilari Sacalm, Girona, Spain, 17403
        • Residència i Centre de dia Sant Hilari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons of any age with or without cognitive impairment living indefinitely in a nursing home

Description

Inclusion Criteria:

  • Persons living in nursing homes
  • Consent from the person (or legal representative, if the person is not able)

Exclusion Criteria:

  • Terminal illness
  • Living temporary in a nursing home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
The control group is made by persons living in nursing homes under usual care

The intervention group made by persons living in nursing homes using a person centered attention model relying on two dimensions:

  1. - Attention to the person based on:

    • Knowledge of the person in several dimensions (biological, psychological, social, etc), interests and preferences.
    • Respect and acknowledge of the person.
    • Promotion of the autonomy.
    • Personalized treatment, with tailored attention and integrative cures
    • Protection of physical well-being, preventing damages and risks and promoting healthy habits.
    • Promotion of independence on daily activities.
    • Protection of privacy and personal matters
  2. - Positive environment based on:

    • Physical space, including accessibility, comfort, homely environment, with stimulating spaces for physical activity, social relationships and significant activities for the persons.
    • Social relationships, with proximity and collaboration with families.
    • Friendly organization, with empathetic professionals empowering users.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thriving in nursing homes
Time Frame: 0, 6 months

Thriving in nursing homes will be assessed with the Thriving of Older People Assessment Scale (TOPAS).

Investigators will assess the change between groups.

0, 6 months
Quality of life
Time Frame: 0, 6 months
Quality of life will be assessed with the Euroqol 5D-5L. Investigators will assess the change between groups.
0, 6 months
Well-being
Time Frame: 0, 6 months
Well-being will be assessed by the WHO (Five) Well Being Index (1998 version). Investigators will assess the change between groups.
0, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 0, 6 months

Cognitive impairment affects the assessment of depressive symptoms. For this reason, according to their stage using the Reisberg Global Deterioration Scale, investigators will assess the presence or absence of depressive symptoms with two tools

  • stage 0 to 4: investigators will consider that a person has depressive symptoms with a score of 6 or more using the 15 items Yesavage Geriatric Depression Scale,
  • stage 5 to 7: investigators will consider that a person has depressive symptoms with a score of 11 or more using the Cornell Depression Scale.

Investigators will assess the change in the prevalence of depressive symptoms between groups.

0, 6 months
Neuropsychiatric inventory
Time Frame: 0,6 months
Neuropsychiatric symptoms will be assessed with the Brief Neuropsychiatric inventory(NPI-Q). Investigators will assess the change between groups.
0,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xavier Rojano Luque, MD, Fundacio Salut i Envelliment UAB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 27, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • FSIE1704
  • CEEAH - 3786 (Other Identifier: Comissió d'Ètica Animal en Experimentació i Humana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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