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Chronic Obstructive Lung Disease (COLD)R'tNCT06897410

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

A study testing Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition in people with Chronic Obstructive Lung Disease (COLD) and Heart Failure, run by Corporació de Salut del Maresme i la Selva at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
13 Jan 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Griselda Manzano Monfort contact

+34620215477

gmanzano@salutms.cat

Noelia Quirant Arellano contact

+34695803416

nquirant@salutms.cat

Spain1 site, 1 recruiting
  • Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva

    Calella, Barcelona, 08370

    Ramon Cunillera Graño, CEO, +34937661562, rcunillera@salutms.cat

    Noelia Quirant Arellano

    Recruiting

Other trials in Spain

About this study

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

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:

Read more

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.

Being tested
Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition
Keywords
Patient Readmission, COLD, Heart Failure, Frail elderly, Multidisciplinary care team
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory ConditionOther

    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

Study groups in NCT06897410
Study groupRoleWhat they receive
Control GroupNo interventionStandard Follow-up under hospital at home regime in our institution
Intervention GroupExperimentalPresential Follow-up by a multidisciplinary team
Receives: Other: Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days after hospital discharge

  2. Reduction of mortality, readmission and nursing home admission

    Measured: 3, 6, 9, and 12 months after hospital discharge

Secondary outcomes (14)
  1. Reduction in Frailty Index Score

    Measured: 30 days after hospital discharge

  2. Reduction of the mortality rate

    Measured: 30 days after hospital discharge

  3. Reduction in the number of inappropriate prescriptions

    Measured: 30 days after hospital discharge

  4. Increase in pharmacotherapeutic adherence

    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

    Measured: 30 days after hospital discharge

  5. Reduction in functional deterioration

    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.

    Measured: 30 days after hospital discharge

  6. Reduction in the risk of falls

    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.

    Measured: 30 days after hospital discharge

  7. Increase in physical function

    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

    Measured: 30 days after hospital discharge

  8. Increase in the number of beneficiaries of social prescribing or community referrals

    Measured: 30 days after hospital discharge

  9. Obtain positive patient satisfaction

    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.

    Measured: 30 days after hospital discharge

  10. Reduction or delay in institutionalization in nursing homes among users

    Measured: 30 days after hospital discharge

  11. Reduction in Zarit Score for caregiver burden

    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.

    Measured: 30 days after hospital discharge

  12. Reduction in the risk of social isolation

    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.

    Measured: 30 days after hospital discharge

  13. Increase in emotional well-being

    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).

    Measured: 30 days after hospital discharge

  14. Increase in the smoking cessation rate

    Measured: 30 days after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start13 Jan 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Intervention Study, control vs intervention group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06897410
Sponsor's protocol ID
R't
Acronym
R't
Status last verified
May 2025
First submitted
6 Mar 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aranda-Gallardo M, Morales-Asencio JM, Canca-Sanchez JC, Morales-Fernandez A, Enriquez de Luna-Rodriguez M, Moya-Suarez AB, Mora-Banderas AM, Perez-Jimenez C, Barrero-Sojo S. [Consequences of errors in the translation of questionnaires: Spanish version of Downton index]. Rev Calid Asist. 2015 Jul-Aug;30(4):195-202. doi: 10.1016/j.cali.2015.04.003. Epub 2015 Jun 9. Spanish.

    PubMed 26068277
  • Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5.

    PubMed 24005886
  • Kocalevent RD, Berg L, Beutel ME, Hinz A, Zenger M, Harter M, Nater U, Brahler E. Social support in the general population: standardization of the Oslo social support scale (OSSS-3). BMC Psychol. 2018 Jul 17;6(1):31. doi: 10.1186/s40359-018-0249-9.

    PubMed 30016997
  • Zamora-Sanchez JJ, Zabaleta-Del-Olmo E, Gea-Caballero V, Julian-Rochina I, Perez-Tortajada G, Amblas-Novellas J. [Convergent and discriminative validity of the Frail-VIG index with the Braden scale in people cared for in home care]. Rev Esp Geriatr Gerontol. 2022 Mar-Apr;57(2):71-78. doi: 10.1016/j.regg.2021.12.003. Epub 2022 Mar 17. Spanish.

    PubMed 35307198
  • Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10.

    PubMed 18619805
  • Pinzon-Pulido S, Garrido Pena F, Reyes Alcazar V, Lima-Rodriguez JS, Raposo Triano MF, Martinez Domene M, Alonso Trujillo F. [Predictors of institutionalization of elderly persons in dependency situation in Andalusia]. Enferm Clin. 2016 Jan-Feb;26(1):23-30. doi: 10.1016/j.enfcli.2015.08.003. Epub 2015 Sep 9. Spanish.

    PubMed 26363992
  • Acosta-Benito MA, Martin-Lesende I. [Frailty in primary care: Diagnosis and multidisciplinary management]. Aten Primaria. 2022 Sep;54(9):102395. doi: 10.1016/j.aprim.2022.102395. Epub 2022 Jun 11. Spanish.

    PubMed 35700618
  • Bayona Huguet X, Limon Ramirez E, Cegri Lombardo F. [Proposals for home care of the XXI century]. Aten Primaria. 2018 May;50(5):264-266. doi: 10.1016/j.aprim.2017.11.003. Epub 2018 Feb 9. No abstract available. Spanish.

    PubMed 29433757
  • Miranda J, Underwood D, Kuepfer-Thomas M, Coulson D, Park AC, Butler SJ, Goldstein R, Brooks D, Everall AC, Guilcher SJT. Exploring transitions in care from pulmonary rehabilitation to home for persons with chronic obstructive pulmonary disease: A descriptive qualitative study. Health Expect. 2020 Apr;23(2):414-422. doi: 10.1111/hex.13012. Epub 2020 Jan 1.

    PubMed 31893574
  • Saavedra-Quiros V, Montero-Hernandez E, Menchen-Viso B, Santiago-Prieto E, Bermejo-Boixareu C, Hernan-Sanz J, Sanchez-Guerrero A, Campo Loarte J. [Medication reconciliation at admission and discharge. A consolidated experience]. Rev Calid Asist. 2016 Jun;31 Suppl 1:45-54. doi: 10.1016/j.cali.2016.02.002. Epub 2016 May 4. Spanish.

    PubMed 27157795
  • Gonzalez-Bueno J, Sevilla-Sanchez D, Puigoriol-Juvanteny E, Molist-Brunet N, Codina-Jane C, Espaulella-Panicot J. Improving medication adherence and effective prescribing through a patient-centered prescription model in patients with multimorbidity. Eur J Clin Pharmacol. 2022 Jan;78(1):127-137. doi: 10.1007/s00228-021-03207-9. Epub 2021 Aug 27.

    PubMed 34448906
  • Doos L, Bradley E, Rushton CA, Satchithananda D, Davies SJ, Kadam UT. Heart failure and chronic obstructive pulmonary disease multimorbidity at hospital discharge transition: a study of patient and carer experience. Health Expect. 2015 Dec;18(6):2401-12. doi: 10.1111/hex.12208. Epub 2014 May 16.

    PubMed 24831061
  • Hirschman KB, Shaid E, McCauley K, Pauly MV, Naylor MD. Continuity of Care: The Transitional Care Model. Online J Issues Nurs. 2015 Sep 30;20(3):1.

    PubMed 26882510
  • Arnar DO, Oddsson SJ, Gunnarsdottir T, Gudlaugsdottir GJ, Gudmundsson EF, Ketilsdottir A, Halldorsdottir H, Hrafnkelsdottir TJ, Hallsson H, Amundadottir ML, Thorgeirsson T. Improving outpatient care for heart failure through digital innovation: a feasibility study. Pilot Feasibility Stud. 2022 Nov 30;8(1):242. doi: 10.1186/s40814-022-01206-w.

    PubMed 36451212
  • Walker RC, Tong A, Howard K, Palmer SC. Patient expectations and experiences of remote monitoring for chronic diseases: Systematic review and thematic synthesis of qualitative studies. Int J Med Inform. 2019 Apr;124:78-85. doi: 10.1016/j.ijmedinf.2019.01.013. Epub 2019 Jan 29.

    PubMed 30784430

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition in people with Chronic Obstructive Lung Disease (COLD) and Heart Failure, run by Corporació de Salut del Maresme i la Selva at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Griselda Manzano Monfort (+34620215477, gmanzano@salutms.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of the Readmission Rate in the Intervention Group (time frame: 30 days after hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06897410, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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