Reforça't: A Community, Social, and Healthcare Program for Patients With Cardiorespiratory Conditions Upon Hospital Discharge
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Reforça't: A Randomized Community Clinical Trial With a Social and Healthcare Approach to Improve Functional Outcomes in Patients With Chronic Cardiac, Respiratory, or Mixed Conditions After Hospital Discharge
1 other identifier
interventional
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
1 active site
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 Start
First participant enrolled
January 13, 2025
CompletedFirst Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 30, 2025
May 1, 2025
1.5 years
March 6, 2025
May 26, 2025
Conditions
Keywords
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 INTERVENTIONStandard Follow-up under hospital at home regime in our institution
Intervention Group
EXPERIMENTALPresential Follow-up by a multidisciplinary team
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
Eligibility Criteria
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
Related Publications (24)
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PMID: 39859079BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- 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