Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva
Calella, Barcelona, 08370, Spain
Location status: Recruiting
Location contact
Noelia Quirant Arellano
SUB_INVESTIGATOR
Ramon Cunillera Graño, CEO
CONTACT
NCT Number: NCT06897410
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Calella, Barcelona, 08370, Spain
Location status: Recruiting
Noelia Quirant Arellano
SUB_INVESTIGATOR
Ramon Cunillera Graño, CEO
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 3, 6, 9, and 12 months after hospital discharge
Time frame: 30 days after hospital discharge
Time frame: 30 days after hospital discharge
Time frame: 30 days after hospital discharge
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 30 days after hospital discharge
The investigators will conduct Short Physical Performance Battery (SPPB) and assess Daniels score, to determine subjects' physical function.
Time frame: 30 days after hospital discharge
Time frame: 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.
Time frame: 30 days after hospital discharge
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 30 days after hospital discharge
Contact information is provided by the study sponsor or research team.
Griselda Manzano Monfort
CONTACT
Noelia Quirant Arellano
CONTACT
Corporació de Salut del Maresme i la Selva
Other
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
Acronym: R't
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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