Reforça't: a Community, Social, and Healthcare Program for Patients with Cardiorespiratory Conditions Upon Hospital Discharge

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Lung Disease (COLD); Heart Failure

• Registration Number: NCT06897410
• Lead Sponsor: Corporació de Salut del Maresme i la Selva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of the Readmission Rate in the Intervention Group	30 days after hospital discharge	We aim for our intervention to result in a 20% reduction of the readmission rate among users included in the experimental group
Reduction of mortality, readmission and nursing home admission	3, 6, 9, and 12 months after hospital discharge

Secondary Outcome Measures

Name	Time	Method
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	We will conduct the spanish version of the Adherence to Refills and Medications Scale (ARMS-e)
Reduction in functional deterioration	30 days after hospital discharge	We will measure Barthel and Lawton scores to determine functional activity
Reduction in the risk of falls	30 days after hospital discharge	We will assess the Downton score. We are expecting this measure to decrease in the intervention group
Increase in physical function	30 days after hospital discharge	We will conduct Short Physical Performance Battery (SPPB) and assess Daniels score, to determine subjects' physical function
Increase in the number of beneficiaries of social prescribing or community referrals	30 days after hospital discharge
Obtain positive patient satisfaction	30 days after hospital discharge	We will administer ad hoc patient satisfaction surveys
Reduction or delay in institutionalization in nursing homes among users	30 days after hospital discharge
Reduction in Zarit Score for caregiver burden	30 days after hospital discharge	We will conduct Zarit Burden Interviews on caregivers for patients included in the study. We expect to reduce the Zarit Score for caregivers included in the study
Reduction in the risk of social isolation	30 days after hospital discharge	We will determine OSSS-3 score for patients included in the study
Increase in emotional well-being	30 days after hospital discharge	We will conduct the short Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) to measure subject emotional well-being
Increase in the smoking cessation rate	30 days after hospital discharge

Trial Locations

Locations (1)

Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva; 🇪🇸 Calella, Barcelona, Spain