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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03200145
Other study ID # FSIE1704
Secondary ID CEEAH - 3786
Status Not yet recruiting
Phase N/A
First received June 20, 2017
Last updated June 26, 2017
Start date June 27, 2017
Est. completion date February 2018

Study information

Verified date June 2017
Source Fundacio Salut i Envelliment UAB
Contact Xavier Rojano Luque, MD
Phone 93 433 50 53
Email xavier.rojano@uab.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Residència i Centre de dia Sant Hilari Sant Hilari Sacalm Girona
Spain Residència "Casa del Avis" Sant Sadurní d'Anoia Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundacio Salut i Envelliment UAB SUMAR empresa d'acció social de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Quality of life Quality of life will be assessed with the Euroqol 5D-5L. Investigators will assess the change between groups. 0, 6 months
Primary 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 Depressive symptoms 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
Secondary Neuropsychiatric inventory Neuropsychiatric symptoms will be assessed with the Brief Neuropsychiatric inventory(NPI-Q). Investigators will assess the change between groups. 0,6 months
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