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

NCT05534737 | Suspended

• 1 other identifier: 216/2022
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Geriatric Care

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Comprehensive and Person-Centered Care Model (AICP Model) +regular assistance from social services

Other: MAICP + usual care of social services

Control

OTHER

regular assistance from social services

Other: Control

Interventions

MAICP + usual care of social services OTHER

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.

Intervention

Control OTHER

usual care of social services

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• those people who during the baseline period (summer 2022) present an event at the end of follow-up (see Variables) will be excluded.

Sponsors & Collaborators

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

Study Sites (1)

Miguel Castillo

Murcia, 30120, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open, multicenter clinical trial

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: August 15, 2022
• Primary Completion: August 15, 2024
• Study Completion: December 15, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

ES (1)