Evaluation of an Integrated Home Care Model

NCT07408882 | Recruiting

• 1 other identifier: PT-072023-EP
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 8

Brief Summary

The demographic shift towards a progressive aging of the population represents an unprecedented challenge for Western societies and for the sustainability of health and social systems. Hypotheses: A complex, multi-component intervention based on integrated home care, facilitated by technological tools and focused on the frail person with complex needs (ADMIT Program):

• Will increase at least 5% of the days spent at home compared to usual care
• Will reduce exacerbations or health or social crisis at home
• Will improve the quality of life and well-being of users and their informal caregiver
• Will improve the experience of the people cared for, their caregivers and professionals in the health and social systems Main objective: To evaluate the effectiveness of the ADMIT program in increasing the % of days at home of frail elderly people compared to usual practice. Secondary objectives: To evaluate the effectiveness of the ADMIT program compared to usual care to reduce exacerbations or situations of crisis that motivate emergency care or hospitalizations. To evaluate the incremental cost-utility ratio of the ADMIT program in relation to usual practice, exploring different time horizons and different scenarios of population scalability. To evaluate the experience of the people treated, their informal caregivers and professionals. To identify the determinants of change and contextual factors of the program implementation process Methodology: Hybrid evaluation model that allows evaluating the process, effectiveness, safety and cost-utility while implementing the intervention in real life. Mixed methods, typical of implementation science, will be used, with different stages: First stage: co-creation of the care model and the technological platform with the participation of users and professionals Second stage: evaluation of the process, results and experience through a pragmatic randomized controlled trial with a batched stepped wedge design and comparison with a parallel "external" control group, matched using propensity score techniques. Applicability and Relevance: The ADMIT program is aligned with the current trend and the shared interest of evolving towards integrated social and health care, keeping people with complex needs in their homes for as long as possible and with the best possible quality of life. The ADMIT project is an implementation project supported by the Catalan Health Department and the Integrated Care Agency. The technological platform that will be co-created and piloted is expected to be adopted by Catalan Health Department for its scaling up in the territory.

Conditions

Older Adults (70 or More) Living at Home With Health and Social Complexity

Keywords

integrated care; implementation science; mixed models; hybrid design

Outcome Measures

Primary Outcomes (1)

• Percentage of days at home

  (Follow up days - (Mortality days + Inpatient Days + Nursing home Days + Home Health Visits + Emergency Department Visits + Inpatient Psychiatry Days + Inpatient Rehabilitation Days + Long term Hospital Days))/follow up days \*100

  During the intervention (6 months from the baseline).

Study Arms (2)

Usual care

NO INTERVENTION

ADMIT Program

EXPERIMENTAL

Other: ADMIT integrated care Program

Interventions

ADMIT integrated care Program OTHER

Participants will be attended following an integrated care program which is being co-created by professionals, patients and caregivers, with the following principles: 1. Proactive detection of candidates from both sides (the health and the social services); 2. Designation of a reference and a co-reference professional, one from each side; 3. Shared situational diagnosis based on a comprehensive geriatric assessment; 4. Definition of a shared individual care pathway; 5. Shared follow up. Using a tehcnological platform to facilitate sharing of information and communication between all stakeholders. In some instances, sensoric and robotic devices will be used to monitor and support home care

ADMIT Program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Living at home AND
• Adjusted Morbidity Group = 3 or 4 or high risk OR Complex or Advanced frailty or chronicity OR Home health care program; AND
• Dependent for the basic daily activities OR Social complexity (SSM-CAT positive) OR Dependency grade= 1, 2 or 3 OR Lack of social support OR Home social care program OR Living alone

You may not qualify if:

• Living in a nursing home
• Unable to make decisions about care (either by the patient or the caregiver)
• Person with needs that exceed the coverage of the program
• Not providing informed consent

Sponsors & Collaborators

• AMADIP: collaborator
• Parc Sanitari Pere Virgili: lead
• CatSalut Catalonia, Spain: collaborator

Study Sites (8)

CAP Larrard

Barcelona, Barcelona, 08041, Spain

RECRUITING

CAP Sarrià

Barcelona, Barcelona, 08041, Spain

RECRUITING

EBA Vallcarca

Barcelona, Spain

RECRUITING

Institut Municipal de Serveis Socials - Ajuntament de Barcelona

Barcelona, Spain

RECRUITING

Institut Català de la Salut - Girona

Girona, Spain

RECRUITING

Consorci Acció Social La Garrotxa

Olot, Spain

NOT YET RECRUITING

Fundació Hospital d'Olot i Comarcal de la Garrotxa

Olot, Spain

RECRUITING

Programa de Gestió d'Atenció a la Complexitat (PGAC)

Vic, Spain

NOT YET RECRUITING

Related Links

• Press release about the project kick off
• Project Web page

Study Officials

• Marco Inzitari, PhD

  Parc Sanitari Pere Virgili

  STUDY DIRECTOR

Central Study Contacts

Aida Ribera-Solé, PhD

CONTACT

+34 932594263; ariberas@perevirgili.cat

Lorena Villa-Garcia, PhD

CONTACT

+34 932594263; lvilla@perevirgili.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Implementation research hybrid model that will allow the evaluation of the process, effectiveness, safety and cost-utility while implementing the intervention in real life. Centers and care teams will start including participants in the ADMIT Program following a batched stepped wedge design. A batched stepped wedge cluster design consists in a series of stepped wedge cluster randomized trials. A stepped wedge analysis includes an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals, or "steps", one cluster, or a group of it, is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: February 13, 2026
• Study Start: May 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

ES (8)