Geriatric CareAICPcomNCT05534737
Clinical Trial on the Effectiveness of the Model of Centered Care in the Person in the Geriatric Population at Home(Project AICP.Com)
A study of Geriatric Care, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
It is an individualized care model and therefore difficult to define in a concrete way: it is based on respect for the individual characteristics of each person (their beliefs, values, preferences, life history, projects, goals...) to find the available family, social and community resources that best suit them in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 15 Aug 2022to 15 Dec 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Situation of Fragility (defined as social vulnerability by Social Services, based on a global qualitative assessment: loneliness, low level of education or resources, home conditions...) or recognized dependency, who live alone and who do not meet criteria for the third group.
- Recognized dependency (classified as grade I, II or III according to the Dependency Law based on autonomy for basic activities measured by the Barthel scale and cognitive impairment according to Pfeiffer) who have cohabitants and who do not meet the criteria for the third group.
- Dependence recognized grade II or III that also meet criteria of clinical complexity, at least 2 major criteria and 1 minor:
- Major Criteria: polypharmacy >4 active prescription drugs, >=2 visits to the emergency room last year, >=1 hospital admission in the last year Minor criteria: diagnosis of heart failure, COPD, dementia, and/or Liver disease / diabetes mellitus / osteoarthritis (2 of these 3).
Who cannot join
- those people who during the baseline period (summer 2022) present an event at the end of follow-up (see Variables) will be excluded.
- Relatives or partners of other participants who have already been recruited for meeting inclusion criteria will also be excluded, with the most dependent person being the one with priority for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Effectiveness of the Model of Centered Care in the Person in the Geriatric Innovative Actions to Advance in the Change of Model Towards Comprehensive and Person-centered Care. AICP.Com
It is an individualized care model and therefore difficult to define in a concrete way: it is based on respect for the individual characteristics of each person (their beliefs, values, preferences, life history, projects, goals...) to find the available family, social and community resources that best suit them in order to promote their autonomy, their quality of life and their emotional well-being.
The design of the randomized clinical trial proposed here is an external collaboration, not financed, which is adapted to the aforementioned project in its community setting and does not affect it beyond the qualification of the definition of the clinical variables of interest without modifying its original design. With it, it seeks to increase the emerging body of published scientific evidence in favor of carrying out this type of community and primary health care interventions that are centered on the person.
Read the detailed description
The project consists of a set of complementary actions that are considered convenient for the implementation and validation of the Comprehensive and Person-Centered Care Model (MAICP) and is aimed at elderly people in a situation of dependency or loneliness in two areas of action: homes and homes in their community settings.
The MAICP is articulated on two axes: placing the person at the center while the other elements revolve around them, and organizing support and care in a coordinated manner so that they are offered to the person in their community environment in an integrated manner and that This is not the one that must adapt to the uncoordinated and fragmented existing services. Specifically in the community environment (population at home), the objective is the articulation and coordination of both formal public services, as well as existing community and proximity resources in each environment to encourage older people to continue living at home and in their community in decent conditions, avoiding institutionalization and without burdening families. Work will be done in close collaboration with community social services so that they appropriate the elements and techniques proposed by the model at the end of the project. In it, methodologies such as community intervention, case management, life history and care plans and support for the life project will be articulated, through a professional relationship that promotes good care and maintenance of the dignity of people and their rights, as well as their autonomy to maintain control of their lives. The synergies and use of existing resources in each environment will affect the effectiveness of the MAICP.
- Conditions
- Geriatric Care
- Being tested
- MAICP + usual care of social services, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAICP + usual care of social servicesOther
The intervention consists of applying a MAICP from the municipal social services involved for 2 years (summer 2022-summer 2024). To this end, the AICP.com project will sign the necessary institutional agreements to contract and integrate, in the municipal Social Services of each territory, an intervention team that will work with them in a coordinated manner, although its specific task is the implementation of the MAICP during the intervention period of the project and the baseline, intermediate and final evaluations of the effectiveness of this model in the study population.
ControlOther
usual care of social services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Comprehensive and Person-Centered Care Model (AICP Model) +regular assistance from social services Receives: Other: MAICP + usual care of social services |
| Control | Other | regular assistance from social services Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment (<23-65%- score in the MEC test of Lobo -see later Scales of social and health evaluation- evaluated in the first visit)
Measured: Up to 2 years
Hospital emergency visits in the last year (up to the date of inclusion, the information will be collected through the contribution of the report or by anamnesis of the participant or caregiver)
Number of visits
Measured: Up to 2 years
Hospital admissions in the last year (up to the date of inclusion, the information will be collected through the contribution of the report or by anamnesis of the participant or caregiver)
Number of admissions
Measured: Up to 2 years
Quality of life/emotional well-being scales, according to cognitive impairment (by MEC result):
Qualid scale (10)The average administration time of the questionnaire is 5 minutes. It has 11 items referring to observable behaviors, indicative of his individual experience with respect to his QoL. They include observation of subjective and affective states of patients
Measured: Up to 2 years
Quality of life/emotional well-being scales, according to cognitive impairment (by MEC result):
CASP-12 scale (Control, Autonomy, Pleasure and Self-realization) is a shortened version of the original CASP-19 scale for quality of life in people aged 65-74 years. is self-administered and consists of 12 items, comprised of 4 areas (Control, Pleasure, Autonomy and Self-actualization), which are evaluated using a 4-point Likert-type scale.
Measured: Up to 2 years
No cognitive impairment (MEC-Lobo >23 - 65%, The WHO-5 scale (12)(WHO-5 in its original version)
evaluates emotional well-being through 3 aspects: positive mood, vitality and general interest. It is a self-administered questionnaire with 5 Likert-type questions (0-5 points), with 0 being the lowest score (less emotional well-being) and 25 the highest (more emotional well-being).
Measured: Up to 2 years
MEC (Mini-Cognitive Examination) by Lobo 1999 (9). The maximum total score is 35 points (cognitive impairment is considered if the score is <23 points)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Why it stopped: Study not carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open, multicenter clinical trial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534737
- Sponsor's protocol ID
- 216/2022
- Acronym
- AICPcom
- Status last verified
- Oct 2023
- First submitted
- 6 Sep 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effectiveness of the Model of Centered Care in the Person in the Geriatric Innovative Actions to Advance in the Change of Model Towards Comprehensive and Person-centered Care. AICP.Com
- ClinicalTrials.gov ID
- NCT05534737
- Acronym / sponsor ID
- AICPcom / 216/2022
- Conditions
- Geriatric Care
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study not carried out
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 9 Sep 2022 (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.
It is an individualized care model and therefore difficult to define in a concrete way: it is based on respect for the individual characteristics of each person (their beliefs, values, preferences, life history, projects, goals...) to find the available family, social and community resources that best suit them in order to promote their autonomy, their quality of life and their emotional well-being.
The design of the randomized clinical trial proposed here is an external collaboration, not financed, which is adapted to the aforementioned project in its community setting and does not affect it beyond the qualification of the definition of the clinical variables of interest without modifying its original design. With it, it seeks to increase the emerging body of published scientific evidence in favor of carrying out this type of community and primary health care interventions that are centered on the person.
Detailed description
The project consists of a set of complementary actions that are considered convenient for the implementation and validation of the Comprehensive and Person-Centered Care Model (MAICP) and is aimed at elderly people in a situation of dependency or loneliness in two areas of action: homes and homes in their community settings.
The MAICP is articulated on two axes: placing the person at the center while the other elements revolve around them, and organizing support and care in a coordinated manner so that they are offered to the person in their community environment in an integrated manner and that This is not the one that must adapt to the uncoordinated and fragmented existing services. Specifically in the community environment (population at home), the objective is the articulation and coordination of both formal public services, as well as existing community and proximity resources in each environment to encourage older people to continue living at home and in their community in decent conditions, avoiding institutionalization and without burdening families. Work will be done in close collaboration with community social services so that they appropriate the elements and techniques proposed by the model at the end of the project. In it, methodologies such as community intervention, case management, life history and care plans and support for the life project will be articulated, through a professional relationship that promotes good care and maintenance of the dignity of people and their rights, as well as their autonomy to maintain control of their lives. The synergies and use of existing resources in each environment will affect the effectiveness of the MAICP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MAICP + usual care of social servicesComprehensive and Person-Centered Care Model (AICP Model) +regular assistance from social services |
| Control | Other | Other: Controlregular assistance from social services |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Situation of Fragility (defined as social vulnerability by Social Services, based on a global qualitative assessment: loneliness, low level of education or resources, home conditions...) or recognized dependency, who live alone and who do not meet criteria for the third group.
- Recognized dependency (classified as grade I, II or III according to the Dependency Law based on autonomy for basic activities measured by the Barthel scale and cognitive impairment according to Pfeiffer) who have cohabitants and who do not meet the criteria for the third group.
- Dependence recognized grade II or III that also meet criteria of clinical complexity, at least 2 major criteria and 1 minor:
- Major Criteria: polypharmacy >4 active prescription drugs, >=2 visits to the emergency room last year, >=1 hospital admission in the last year Minor criteria: diagnosis of heart failure, COPD, dementia, and/or Liver disease / diabetes mellitus / osteoarthritis (2 of these 3).
Key exclusion criteria (2 listed)
- those people who during the baseline period (summer 2022) present an event at the end of follow-up (see Variables) will be excluded.
- Relatives or partners of other participants who have already been recruited for meeting inclusion criteria will also be excluded, with the most dependent person being the one with priority for inclusion in the study.
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 |
|---|---|---|
| MAICP + usual care of social servicesThe intervention consists of applying a MAICP from the municipal social services involved for 2 years (summer 2022-summer 2024). To this end, the AICP.com project will sign the necessary institutional agreements to contract and integrate, in the municipal Social Services of each territory, an intervention team that will work with them in a coordinated manner, although its specific task is the implementation of the MAICP during the intervention period of the project and the baseline, intermediate and final evaluations of the effectiveness of this model in the study population. | Other | Intervention |
| Controlusual care of social services | Other | Control |
Primary outcome
Cognitive impairment (<23-65%- score in the MEC test of Lobo -see later Scales of social and health evaluation- evaluated in the first visit)
Time frame: Up to 2 years
Hospital emergency visits in the last year (up to the date of inclusion, the information will be collected through the contribution of the report or by anamnesis of the participant or caregiver)
Time frame: Up to 2 years
Number of visits
Hospital admissions in the last year (up to the date of inclusion, the information will be collected through the contribution of the report or by anamnesis of the participant or caregiver)
Time frame: Up to 2 years
Number of admissions
Quality of life/emotional well-being scales, according to cognitive impairment (by MEC result):
Time frame: Up to 2 years
Qualid scale (10)The average administration time of the questionnaire is 5 minutes. It has 11 items referring to observable behaviors, indicative of his individual experience with respect to his QoL. They include observation of subjective and affective states of patients
Quality of life/emotional well-being scales, according to cognitive impairment (by MEC result):
Time frame: Up to 2 years
CASP-12 scale (Control, Autonomy, Pleasure and Self-realization) is a shortened version of the original CASP-19 scale for quality of life in people aged 65-74 years. is self-administered and consists of 12 items, comprised of 4 areas (Control, Pleasure, Autonomy and Self-actualization), which are evaluated using a 4-point Likert-type scale.
No cognitive impairment (MEC-Lobo >23 - 65%, The WHO-5 scale (12)(WHO-5 in its original version)
Time frame: Up to 2 years
evaluates emotional well-being through 3 aspects: positive mood, vitality and general interest. It is a self-administered questionnaire with 5 Likert-type questions (0-5 points), with 0 being the lowest score (less emotional well-being) and 25 the highest (more emotional well-being).
MEC (Mini-Cognitive Examination) by Lobo 1999 (9). The maximum total score is 35 points (cognitive impairment is considered if the score is <23 points)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Geriatric Care, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site 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 4 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: paused, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (<23-65%- score in the MEC test of Lobo -see later Scales of social and health evaluation- evaluated in the first visit) (time frame: Up to 2 years). The study lists 7 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 26 Oct 2023.