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Coaching sanitario per pazienti con malattia cardiovascolare

9 novembre 2026 aggiornato da: Beth Steinberg, Ohio State University

Coaching sanitario per i pazienti con malattia cardiovascolare: una valutazione dei metodi misti dell'impatto sui risultati dei pazienti e sulla soddisfazione e accettabilità del fornitore

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress, anxiety, depression, and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.

Tipo di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Maryanna Klatt, PhD
  • Numero di telefono: 614-293-3644
  • Email: klatt.8@osu.edu

Luoghi di studio

    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • The Ohio State University Wexner Medical Center
        • Contatto:
        • Contatto:
          • Maryanna Klatt, PhD
          • Numero di telefono: 614-293-3644
          • Email: Klatt.8@osu.edu
        • Investigatore principale:
          • Beth Steinberg, PhD, RN

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 18 years of age or older
  • diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
  • physical condition effectively managed by routine healthcare and not requiring urgent medical attention
  • ability to communicate in English
  • access to a working phone or computer and ability to communicate via phone or computer.

Exclusion Criteria:

  • Patients who have had chest coronary artery bypass surgery
  • Documented cognitive and/or major psychiatric disorders, including dementia, Alzheimer's, depression or anxiety uncontrolled by anxiolytic, anti-psychotic, and/or anti-depressants and/or PHQ-9 score 15-27 and GAD-7 score >15
  • current alcohol or drug dependency
  • resident of extended care/skilled facility
  • prisoners or ward of state.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Health Coaching Intervention Group

Participants will receive 12 health coaching sessions post-discharge over a 16 week period

12 virtual health coaching sessions will be provided over a 16 week period by a certified health coach.

Nessun intervento: Standard Care Group

Participants will receive usual post-discharge care over the 16 week period

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body weight
Lasso di tempo: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge

Patient body weight in kilograms will be obtained by clinical staff on hospital approved and calibrated electronic standing scales. The patient's body weight will be collected from the patient's electronic medical record.

Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
Hospital readmissions
Lasso di tempo: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record

Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease

Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
MyChart messages
Lasso di tempo: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge

MyChart messages are questions or requests directed to the patient's provider that are related to the patient's cardiovascular disease diagnosis and hospitalization. These MyChart messages are entered into the electronic medical record by the patient and are directed to their provider, requiring an electronic or telephone response to the patient with a documented note entered by the provider relative to the follow-up provided to the patient. This outcome measure will be the number of MyChart messages entered by the patient and responded to by the provider.

Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
Perceived Stress
Lasso di tempo: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge

Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
Medication Adherence
Lasso di tempo: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge

The Hill-Bone Medication Adherence Scale (MB-MAS) is a 9-item self-assessment of medication adherence relative to a variety of chronic diseases and conditions. Likert Scale responses to each of the nine statements include 1 (all of the time), 2 (most of the time), 3 (some of the time), and 4 (none of the time). Total scores range from 4 to 36 with higher scores indicating higher medication adherence.

Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Lifestyle Medicine Behavior Assessment
Lasso di tempo: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge

The Lifestyle Medicine Short Form is a 14-item self-assessment scale evaluating physical, emotional, social lifestyle behaviors. The assessment questions comprise core metrics that capture readiness to change, as well as health behaviors that are aligned with the six pillars of lifestyle medicine--physical activity, nutrition, sleep health, stress reduction, social connections, and risky substances. Questions have multiple responses based on information relating to the six pillars of lifestyle medicine. The first two questions related to Readiness to Change use a Likert Scale ranging from 0 (Not Ready) to 10 (Very Ready). Questions related to Motivation and Diet request that the participant denote different aspects of their diet. Physical exercise questions request specific days/times in minutes completed. Questions related to sleep request average hours of sleep per 24 hour period. Mood, connectedness with others, and substance use request types/amounts per week.

Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Acceptability of Intervention Measure
Lasso di tempo: Completed after the 16 week health coaching intervention for participants in the intervention group.

The Acceptability of Intervention Measure (AIM) is a 4-item self-report assessment to evaluate the acceptability of the health coaching intervention. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores ranges from 4-20 with higher total scores indicating higher acceptability.

Completed after the 16 week health coaching intervention for participants in the intervention group.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Qualitative Comments
Lasso di tempo: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge

Patient perceptions of the health coaching intervention will be solicited with the following question prompts: 1) Can you provide feedback about your health coaching experience?; 2) Did working with the health coach help you meet your health goals?; 3) Would you recommend working with a health coach to others?

Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
Provider Qualitative Comments
Lasso di tempo: Will be completed within one month of their patient completing the health coach intervention.

Provider perceptions of the value of the health coach as part of the interprofessional team and the feasibility of integrating the health coach into the patient's care will be solicited via question prompts that will include: 1) Can you discuss your perceptions about the value of the health coach as a member of the patient's care team; 2) Were you able to review the health coaches notes in the patient's medical record? (if yes) Were the notes helpful to you during the patient's follow-up appointment(s), i.e. in addressing the patient's condition, their post-discharge recovery, adherence to medical instructions, progress or lack of progress?; 3) Can you provide your perceptions of the feasibility of integrating the health coach as part of the patient's care team?

Will be completed within one month of their patient completing the health coach intervention.
Patient Health Questionnaire (PHQ-9)
Lasso di tempo: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

A 9-item depression module the Patient Health Questionnaire that scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day); scores range from 9-27.

Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Generalized Anxiety Disorder-7 (GAD-7)
Lasso di tempo: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

A 7-item screening tool assessing anxiety over the past 2 weeks. Questions are scored from "0" (not at all) to "3" (nearly every day). Scores range from 0-21.

Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Beth Steinberg, PhD, RN, Ohio State University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

3 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

24 marzo 2025

Primo Inserito (Effettivo)

1 aprile 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2024H0179

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IPD that will be shared will include de-identified descriptive data for both the intervention and control groups, including gender, race, educational level and mean age. Additionally, cardiovascular disease diagnoses, hospital readmissions at 30-, 60-, and 90- days post-hospital discharge, and number of MyChart messages sent by the patient to their provider. Acceptability of the intervention descriptive data for the intervention group will also be included. Differences in mean scores between the intervention and control groups for weight (significance and effect sizes), perceived stress and medication adherence will be shared. De-identified, curated qualitative data that will be shared includes interview transcripts from both patients and providers, as well as the qualitative codebooks and thematic analysis.

Periodo di condivisione IPD

12-30-2026 to indefinitely

Criteri di accesso alla condivisione IPD

De-identified and curated demographic, statistical data, study overview, study consent will be accessible to academic researchers and educators through a data accessibility link once the Qualitative Data Repository submission is finalized.

Tipo di informazioni di supporto alla condivisione IPD

  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .