NCT06897410

Brief Summary

The goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge. The main questions it aims to answer are: Can the Reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? Does participation in Reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population? Researchers will compare patients enrolled in Reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness. Participants will: Undergo a pre- and post-intervention assessment (30 days post-discharge). Receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services. Be monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

March 6, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

Patient ReadmissionCOLDHeart FailureFrail elderlyMultidisciplinary care team

Outcome Measures

Primary Outcomes (2)

  • Reduction of the Readmission Rate in the Intervention Group

    The investigators aim for the intervention to result in a 20% reduction of the readmission rate among users included in the experimental group

    30 days after hospital discharge

  • Reduction of mortality, readmission and nursing home admission

    3, 6, 9, and 12 months after hospital discharge

Secondary Outcomes (14)

  • Reduction in Frailty Index Score

    30 days after hospital discharge

  • Reduction of the mortality rate

    30 days after hospital discharge

  • Reduction in the number of inappropriate prescriptions

    30 days after hospital discharge

  • Increase in pharmacotherapeutic adherence

    30 days after hospital discharge

  • Reduction in functional deterioration

    30 days after hospital discharge

  • +9 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Standard Follow-up under hospital at home regime in our institution

Intervention Group

EXPERIMENTAL

Presential Follow-up by a multidisciplinary team

Other: Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition

Interventions

Intervention Phase 1: Feasibility Assessment Duration: January 7, 2025 - January 11, 2025 Participants: 10-15 patients Description: All involved services will be available to address and resolve potential issues. The objective is to assess the feasibility of the program, ensuring that the intervention can be implemented as planned and identifying any practical or logistical challenges. Phases 2 \& 3: Comprehensive Intervention Duration: January 12, 2025 - June 30, 2025 Participants: 200 patients Description: Full-scale implementation of the intervention. Includes interdisciplinary care, home follow-ups, therapeutic optimization, functional rehabilitation, health education, and psychosocial support. Phase 4: Long-Term Follow-Up Duration: April 7, 2025 - June 30, 2026 Participants: 200 patients Description: Follow-up assessments at 3, 6, 9, and 12 months post-intervention. Evaluates hospital readmissi

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Users admitted to the Polivalent Observation Units, Internal Medicine, or Hospital at home.
  • Individuals aged 65 years or older.
  • Hospital admission due to decompensation of a cardiac, respiratory, or mixed condition.
  • Place of residence within the health coverage area of Sant Jaume de Calella Hospital - Corporació de Salut del Maresme i la Selva.
  • Willingness to participate in the study as gathered by the signing of an informed consent document

You may not qualify if:

  • Users institutionalized in a nursing home
  • Users already enrolled in home care programs
  • Users in the Advanced Chronic Care Model program with a limited life prognosis
  • Users on the waiting list for organ transplantation
  • Users with language barriers
  • Users with a GDS (Global Deterioration Scale) score of 5 or higher
  • Users who have already been included in the Reforça't program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva

Calella, Barcelona, 08370, Spain

RECRUITING

Related Publications (24)

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    PMID: 35700618BACKGROUND
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    PMID: 29433757BACKGROUND
  • Miranda J, Underwood D, Kuepfer-Thomas M, Coulson D, Park AC, Butler SJ, Goldstein R, Brooks D, Everall AC, Guilcher SJT. Exploring transitions in care from pulmonary rehabilitation to home for persons with chronic obstructive pulmonary disease: A descriptive qualitative study. Health Expect. 2020 Apr;23(2):414-422. doi: 10.1111/hex.13012. Epub 2020 Jan 1.

    PMID: 31893574BACKGROUND
  • Saavedra-Quiros V, Montero-Hernandez E, Menchen-Viso B, Santiago-Prieto E, Bermejo-Boixareu C, Hernan-Sanz J, Sanchez-Guerrero A, Campo Loarte J. [Medication reconciliation at admission and discharge. A consolidated experience]. Rev Calid Asist. 2016 Jun;31 Suppl 1:45-54. doi: 10.1016/j.cali.2016.02.002. Epub 2016 May 4. Spanish.

    PMID: 27157795BACKGROUND
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    PMID: 34448906BACKGROUND
  • Doos L, Bradley E, Rushton CA, Satchithananda D, Davies SJ, Kadam UT. Heart failure and chronic obstructive pulmonary disease multimorbidity at hospital discharge transition: a study of patient and carer experience. Health Expect. 2015 Dec;18(6):2401-12. doi: 10.1111/hex.12208. Epub 2014 May 16.

    PMID: 24831061BACKGROUND
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  • Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish.

    PMID: 28029467BACKGROUND
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  • Fernandez-Gasso L, Hernando-Arizaleta L, Palomar-Rodriguez JA, Abellan-Perez MV, Hernandez-Vicente A, Pascual-Figal DA. Population-based Study of First Hospitalizations for Heart Failure and the Interaction Between Readmissions and Survival. Rev Esp Cardiol (Engl Ed). 2019 Sep;72(9):740-748. doi: 10.1016/j.rec.2018.08.014. Epub 2018 Sep 24. English, Spanish.

    PMID: 30262426BACKGROUND
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    PMID: 25027627BACKGROUND
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  • Laudicella M, Li Donni P, Smith PC. Hospital readmission rates: signal of failure or success? J Health Econ. 2013 Sep;32(5):909-21. doi: 10.1016/j.jhealeco.2013.06.004. Epub 2013 Jun 28.

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  • S Alsulymani A, Ashram W, Alghamdi A, Hafiz HW, Ghunaim AM, Aljehani B, Aljabri A, Alzahrani G. Risk Factors for Readmission in Heart Failure Within 90 Days. Cureus. 2023 Dec 9;15(12):e50236. doi: 10.7759/cureus.50236. eCollection 2023 Dec.

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    PMID: 39859079BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure

Interventions

Aging

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Central Study Contacts

Griselda Manzano Monfort

CONTACT

Noelia Quirant Arellano

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Intervention Study, control vs intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Hospital At Home Unit at Corporació de Salut del Maresme i la Selva (CSMS). Postdoctoral researcher at Digital Health Research Group (IDIBGI-CSMS)

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 26, 2025

Study Start

January 13, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations