Health Services for the AgedRECENPENCT03200145
Person Centered Nursing Homes: Impact Assessment Of Centered Person Care In Nursing Homes
An observational study of Health Services for the Aged and Quality of Life, run by Fundacio Salut i Envelliment UAB at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Services for the Aged, Quality of Life, Mood
- What is being tested?
- ACP intervention
- How many people
- 170 participants
- Where
- 2 sitesSpain
- Study dates
- 27 Jun 2017to Feb 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons of any age with or without cognitive impairment living indefinitely in a nursing home
Who may be able to join
- Persons living in nursing homes
- Consent from the person (or legal representative, if the person is not able)
Who cannot join
- Terminal illness
- Living temporary in a nursing home
Trial locations and contacts
2 sites in 1 country.
Antoni Salvà Casanovas, MD contact
Spain2 sites
Residència i Centre de dia Sant Hilari
Sant Hilari Sacalm, Girona, 17403
Gemma Puig, +34 972872800, gpuig@sumaracciosocial.cat
Residència "Casa del Avis"
Sant Sadurní d'Anoia, Barcelona, 08770
Aida Batet, +34 93 891 14 66, abatet@sumaracciosocial.cat
Neus Montserrat, nmontserrat@sumaracciosocial.cat
About this study
Official title: 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.
- Conditions
- Health Services for the Aged, Quality of Life, Mood
- Being tested
- ACP intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | The control group is made by persons living in nursing homes under usual care Receives: Other: ACP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6 months
Quality of life
Quality of life will be assessed with the Euroqol 5D-5L. Investigators will assess the change between groups.
Measured: 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.
Measured: 0, 6 months
Secondary outcomes (2)
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.
Measured: 0, 6 months
Neuropsychiatric inventory
Neuropsychiatric symptoms will be assessed with the Brief Neuropsychiatric inventory(NPI-Q). Investigators will assess the change between groups.
Measured: 0,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start27 Jun 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Collaborators
- SUMAR empresa d'acció social de Catalunya
- Responsible party
- Sponsor
- Investigators
- Xavier Rojano Luque, MD, Principal investigator, Fundació Salut i Envelliment UAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200145
- Sponsor's protocol ID
- FSIE1704
- Other IDs
- CEEAH - 3786
- Acronym
- RECENPE
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residències Centrades en Les Persones (RECENPE): avaluació de l'Impacte d'un Model d'ACP en residències Per Persones Grans
- ClinicalTrials.gov ID
- NCT03200145
- Acronym / sponsor ID
- RECENPE / FSIE1704
- Conditions
- Health Services for the Aged, Quality of Life, Mood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Collaborators
- SUMAR empresa d'acció social de Catalunya
- Study start
- 27 Jun 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: ACP interventionThe control group is made by persons living in nursing homes under usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons of any age with or without cognitive impairment living indefinitely in a nursing home
Key inclusion criteria (2 listed)
- Persons living in nursing homes
- Consent from the person (or legal representative, if the person is not able)
Key exclusion criteria (2 listed)
- Terminal illness
- Living temporary in a nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP interventionThe 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. | Other | Control |
Primary outcome
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.
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.
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.
2 secondary outcomes
Depressive symptoms
Time frame: 0, 6 months
Neuropsychiatric inventory
Time frame: 0,6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Salvà Casanovas, MD contact
Xavier Rojano Luque, MD principal investigator
Fundació Salut i Envelliment UAB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services for the Aged and Quality of Life, run by Fundacio Salut i Envelliment UAB at 2 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Rojano Luque, MD (93 433 50 53, xavier.rojano@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thriving in nursing homes (time frame: 0, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.