Clinical trial NCT06897410: Reforça't: A Community, Social, and Healthcare Program for Patients With Cardiorespiratory Conditions Upon Hospital Discharge
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Lung Disease (COLD)
Heart Failure
Keywords: Patient Readmission
COLD
Heart Failure
Frail elderly
Multidisciplinary care team
Lead sponsor: Corporació de Salut del Maresme i la Selva
Sponsor class: OTHER
Collaborators: name: Consorci Sanitari de Terrassa
First posted: 2025-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Intervention Study, control vs intervention group
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of the Readmission Rate in the Intervention Group
timeFrame: 30 days after hospital discharge
measure: Reduction of mortality, readmission and nursing home admission
timeFrame: 3, 6, 9, and 12 months after hospital discharge
Secondary outcomes:
measure: Reduction in Frailty Index Score
timeFrame: 30 days after hospital discharge
measure: Reduction of the mortality rate
timeFrame: 30 days after hospital discharge
measure: Reduction in the number of inappropriate prescriptions
timeFrame: 30 days after hospital discharge
measure: Increase in pharmacotherapeutic adherence
timeFrame: 30 days after hospital discharge
measure: Reduction in functional deterioration
timeFrame: 30 days after hospital discharge
measure: Reduction in the risk of falls
timeFrame: 30 days after hospital discharge
measure: Increase in physical function
timeFrame: 30 days after hospital discharge
measure: Increase in the number of beneficiaries of social prescribing or community referrals
timeFrame: 30 days after hospital discharge
measure: Obtain positive patient satisfaction
timeFrame: 30 days after hospital discharge
measure: Reduction or delay in institutionalization in nursing homes among users
timeFrame: 30 days after hospital discharge
measure: Reduction in Zarit Score for caregiver burden
timeFrame: 30 days after hospital discharge
measure: Reduction in the risk of social isolation
timeFrame: 30 days after hospital discharge
measure: Increase in emotional well-being
timeFrame: 30 days after hospital discharge
measure: Increase in the smoking cessation rate
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: Calella
country: Spain
facility: Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva
state: Barcelona
Study officials:
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