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
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• 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 mortality, readmission and nursing home admission	3, 6, 9, and 12 months after hospital discharge
Reduction of the Readmission Rate in the Intervention Group	30 days after hospital discharge	The investigators aim for the intervention to result in a 20% reduction of the readmission rate among users included in the experimental group

Secondary Outcome Measures

Name	Time	Method
Reduction in the number of inappropriate prescriptions	30 days after hospital discharge
Reduction in Frailty Index Score	30 days after hospital discharge
Reduction of the mortality rate	30 days after hospital discharge
Increase in pharmacotherapeutic adherence	30 days after hospital discharge	The investigators will conduct the spanish version of the Adherence to Refills and Medications Scale (ARMS-e).; Per this scale, high scores indicate low therapeutic adherence. Subjects are classified into high adherence (scores from 0 to 16), intermediate adherence (scores from 17 to 32), and low adherence (scores from 33 to 48).; - Expected experimental range values: 12 - 48
Reduction in functional deterioration	30 days after hospital discharge	The investigators will measure Barthel and Lawton scores to determine functional activity.; Barthel index indicates the ability to perform daily tasks autonomously. Higher Barthel index equals higher degree of autonomy. Values range from 0 to 100. Scores lower than 20 indicate total dependence, between 20 and 35 equal severe dependence, between 50 and 55 indicate moderate dependence, between 60 and 90 indicate light dependent, and higher than 95 indicate autonomy.; Lawton and Brody scores measure the degree of autonomy in the performance of instrumental activities of daily living. Values range from 0 to 8, with higher score indicating higher autonomy.
Reduction in the risk of falls	30 days after hospital discharge	The investigators will assess the Downton score. This measure is expected to decrease in the intervention group. Values range from 0 to 11, where higher score equals higher risk. Starting at 3, the values are considered to indicate relevant risk of fall.
Increase in physical function	30 days after hospital discharge	The investigators will conduct Short Physical Performance Battery (SPPB) and assess Daniels score, to determine subjects' physical function.; * SPPB values range from 0 to 12. Higher score equals higher physical function (less frailty). Values lower than 10 indicate clinically relevant frailty and risk of falls; * Daniel's score values range from 0 to 5. Higher values indicate higher strength for the evaluated muscle. Each value indicates; i) 0-absence of contraction, ii) 1- contraction without movement, iii) 2- movement with gravity eliminated iv) 3-full range of motion against gravity, v) 4-full range of motion against moderate resistance, vi) 5-full range of motion against maximum resistance
Increase in the number of beneficiaries of social prescribing or community referrals	30 days after hospital discharge
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	The investigators will conduct Zarit Burden Interviews (ZBI) on caregivers for patients included in the study. Specifically, the short ZBI-7 will be assessed. It consists of 7 items, each item scoring from 1 to 5. Per this score, the higher the score equals a higher caregiver burden. Thus, a reduction in the Zarit Score for caregivers included in the study is expected.; The obtained values per caregiver range from 7 to 35, and a total score of 17 or higher is considered excessive burden.
Reduction in the risk of social isolation	30 days after hospital discharge	The investigators will determine OSSS-3 score for patients included in the study.; Higher scores determine higher perception of social support. Scores between 3 and 8 equal low social support, between 9 and 11 intermediate social support, and higher scores equal high social support. The patients included in the study are expected to range between 3 and 14.
Increase in emotional well-being	30 days after hospital discharge	The investigators will conduct the short Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) to measure subject emotional well-being. Higher scores indicate better emotional wellbeing. A score lower than 26 is considered to relate to emotional discomfort. The patients included are expected to range between 7 and 35 in score (35 is the maximum score for this short version).
Obtain positive patient satisfaction	30 days after hospital discharge	The investigators will administer ad hoc patient satisfaction surveys. Results will be numerical, from 0 (min) to 10 (max). Average above 7 will be considered a success, although results greater than 5 will be deemed satisfactory.
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