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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200145
Recruitment Status : Unknown
Verified June 2017 by Fundacio Salut i Envelliment UAB.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
SUMAR empresa d'acció social de Catalunya
Information provided by (Responsible Party):
Fundacio Salut i Envelliment UAB

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.


Condition or disease Intervention/treatment
Health Services for the Aged Quality of Life Mood Other: ACP intervention

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Residències Centrades en Les Persones (RECENPE): avaluació de l'Impacte d'un Model d'ACP en residències Per Persones Grans
Estimated Study Start Date : June 27, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Group/Cohort Intervention/treatment
Control
The control group is made by persons living in nursing homes under usual care
Other: ACP intervention

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.




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons of any age with or without cognitive impairment living indefinitely in a nursing home
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200145


Contacts
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Contact: Xavier Rojano Luque, MD 93 433 50 53 xavier.rojano@uab.cat
Contact: Antoni Salvà Casanovas, MD antoni.salva@uab.cat

Locations
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Spain
Residència "Casa del Avis"
Sant Sadurní d'Anoia, Barcelona, Spain, 08770
Contact: Aida Batet    +34 93 891 14 66    abatet@sumaracciosocial.cat   
Contact: Neus Montserrat       nmontserrat@sumaracciosocial.cat   
Residència i Centre de dia Sant Hilari
Sant Hilari Sacalm, Girona, Spain, 17403
Contact: Gemma Puig    +34 972872800    gpuig@sumaracciosocial.cat   
Sponsors and Collaborators
Fundacio Salut i Envelliment UAB
SUMAR empresa d'acció social de Catalunya
Investigators
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Principal Investigator: Xavier Rojano Luque, MD Fundació Salut i Envelliment UAB
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Responsible Party: Fundacio Salut i Envelliment UAB
ClinicalTrials.gov Identifier: NCT03200145    
Other Study ID Numbers: FSIE1704
CEEAH - 3786 ( Other Identifier: Comissió d'Ètica Animal en Experimentació i Humana )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No