NCT03200145

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 20, 2017

Last Update Submit

June 26, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Thriving in nursing homes

    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

    Quality of life will be assessed with the Euroqol 5D-5L. Investigators will assess the change between groups.

    0, 6 months

  • Well-being

    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 Outcomes (2)

  • Depressive symptoms

    0, 6 months

  • Neuropsychiatric inventory

    0,6 months

Study Arms (1)

Control

The control group is made by persons living in nursing homes under usual care

Other: ACP intervention

Interventions

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.

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Terminal illness
  • Living temporary in a nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Residència "Casa del Avis"

Sant Sadurní d'Anoia, Barcelona, 08770, Spain

Location

Residència i Centre de dia Sant Hilari

Sant Hilari Sacalm, Girona, 17403, Spain

Location

Study Officials

  • Xavier Rojano Luque, MD

    Fundació Salut i Envelliment UAB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Rojano Luque, MD

CONTACT

Antoni Salvà Casanovas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

June 27, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations