Clinical Trial on the Effectiveness of the Model of Centered Care in the Person in the Geriatric Population at Home(Project AICP.Com) (AICPcom)

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.

Study Overview

• Status: Suspended
• Conditions: Geriatric Care
• Intervention / Treatment: Other: MAICP + usual care of social services; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Castillo Sanchez, MD; Phone Number: 968381290; Email: doctor.miguel.castillo@gmail.com

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Miguel Castillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.
3. 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Comprehensive and Person-Centered Care Model (AICP Model) +regular assistance from social services	Other: MAICP + usual care of social services; 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.
Other: Control; regular assistance from social services	Other: Control; usual care of social services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive impairment (<23-65%- score in the MEC test of Lobo -see later Scales of social and health evaluation- evaluated in the first visit)		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	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	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	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.	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).	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)		Up to 2 years

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 216/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No