- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408882
Evaluation of an Integrated Home Care Model (ADMIT)
Integrated Home Care (ADMIT). Transforming the Model of Home Care Though Technology and Integrated Health and Social Care
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aida Ribera-Solé, PhD
- Phone Number: +34 932594263
- Email: ariberas@perevirgili.cat
Study Contact Backup
- Name: Lorena Villa-Garcia, PhD
- Phone Number: +34 932594263
- Email: lvilla@perevirgili.cat
Study Locations
-
-
-
Barcelona, Spain
- Recruiting
- EBA Vallcarca
-
Contact:
- Rosario Jiménez
- Phone Number: +34 629 423 337
- Email: rjimenez@ebavallcarca.cat
-
Barcelona, Spain
- Recruiting
- Institut Municipal de Serveis Socials - Ajuntament de Barcelona
-
Contact:
- Silvia Ramírez
- Phone Number: 669 623 868
- Email: sramirezp@bcn.cat
-
Girona, Spain
- Recruiting
- Institut Català de la Salut - Girona
-
Contact:
- Rafael Ramos
- Phone Number: +34 607 074 712
- Email: rramos.girona.ics@gencat.cat
-
Olot, Spain
- Not yet recruiting
- Consorci Acció Social La Garrotxa
-
Contact:
- Elena Güell
- Phone Number: +34 606 654 929
- Email: eguell@casg.cat
-
Olot, Spain
- Recruiting
- Fundació Hospital d'Olot i Comarcal de la Garrotxa
-
Contact:
- Glòria Bassets
- Phone Number: +34 690 932 380
- Email: gbassets@hospiolot.cat
-
Vic, Spain
- Not yet recruiting
- Programa de Gestió d'Atenció a la Complexitat (PGAC)
-
Contact:
- Rosa Planesas
- Phone Number: + 34 667 007 846
- Email: mrplanesas@catsalut.cat
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08041
- Recruiting
- CAP Larrard
-
Contact:
- MIriam Aballí
- Phone Number: +34 606660084
- Email: maballi@perevirgili.cat
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Barcelona, Barcelona, Spain, 08041
- Recruiting
- CAP Sarrià
-
Contact:
- Veronica Guillot
- Phone Number: +34 685 219 774
- Email: veronicaguillot@capsarria.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
|
|
|
Experimental: ADMIT Program
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of days at home
Time Frame: During the intervention (6 months from the baseline).
|
(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).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marco Inzitari, PhD, Parc Sanitari Pere Virgili
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PT-072023-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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