protocolSection identificationModule nctId: NCT06285565, orgStudyIdInfo id: CE390/2023, briefTitle: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure, acronym: INTERCOACH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Alberto Dal Molin, class: OTHER, collaborators name: Azienda Ospedaliero Universitaria Maggiore della Carita, descriptionModule briefSummary: The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:* Are implementation strategies effective in facilitating participant fidelity?* What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?* Are the methods and tools established the most appropriate to ensure the completeness of the data collection?Participants will follow a combined intervention consisting of:1. pre-discharge educational meeting;2. telephone nurse-led coaching sessions;3. home telemonitoring of vital signs.In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities, conditionsModule conditions: Heart Failure, conditions: Telemonitoring, conditions: Hospitalizations, conditions: Feasibility, conditions: Mentoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel, open-label randomized controlled feasibility study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Nurse-led telephone coaching intervention with home telemonitoring of vital signs, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Adherence to the coaching intervention, primaryOutcomes measure: Adherence to telemonitoring program, primaryOutcomes measure: Completeness of data collection, secondaryOutcomes measure: 90- and 180-day all-cause hospital readmissions, secondaryOutcomes measure: 90- and 180-day heart failure-related hospital readmissions, secondaryOutcomes measure: 90- and 180-day Emergency Departments visits, secondaryOutcomes measure: 90- and 180-day General Practioner visits, secondaryOutcomes measure: 90- and 180-day oupatient visits, secondaryOutcomes measure: Self-care capacity (Self-Care of Heart Failure Index ), secondaryOutcomes measure: Self Care - Self-Efficacy Scale, secondaryOutcomes measure: Quality of life (SF-12 scale), secondaryOutcomes measure: Anxiety (Hamilton Anxiety Scale ), secondaryOutcomes measure: Depression (Geriatric Depression Scale), secondaryOutcomes measure: Heart Failure Somatic Perception Scale v.3 (HFSPS), secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università del Piemonte Orientale Amedeo Avogadro, city: Novara, zip: 28100, country: Italy, contacts name: Alberto Dal Molin, Prof, role: CONTACT, phone: +390321660607, email: alberto.dalmolin@med.uniupo.it, contacts name: INES BASSO, role: CONTACT, phone: +393927599727, email: ines.basso@uniupo.it, geoPoint lat: 45.44694, lon: 8.62118, hasResults: False