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Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)

12 giugno 2018 aggiornato da: VA Office of Research and Development

Representational Telehealth Nursing Intervention for Veterans With CHD

The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Fase 2

Contatti e Sedi

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

Luoghi di studio

  • Stati Uniti
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52246-2208
        • Iowa City VA Health Care System, Iowa City, IA

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:

  • Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
  • Age

Exclusion Criteria:

  • Altered mental status
  • Language barriers
  • Dementia or Cognitive Impairment
  • Diagnostic Study
  • Resident in long-term care facility prior to the present admission
  • Planned discharge to a skilled or intermediate care facility or hospice
  • Lack of access to a functioning phone

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Motivational Interview
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
Comportamentale: Motivational Interview
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
Nessun intervento: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SF-36v Physical Function Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Physical Health Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Emotional Problems Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Energy-Fatigue Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Emotional Well-Being Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Social Functioning Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v Pain Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
SF-36v General Health Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Physical Limitations Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Stability Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Frequency Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Treatment Satisfaction Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Disease Perception Scale
Lasso di tempo: Change from baseline to 3-months post hospital discharge
Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Change from baseline to 3-months post hospital discharge

Collaboratori e investigatori

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

Sponsor

VA Office of Research and Development

Collaboratori

University of Iowa

Investigatori

  • Investigatore principale: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA

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 (Effettivo)

30 aprile 2012

Completamento primario (Effettivo)

30 giugno 2012

Completamento dello studio (Effettivo)

31 ottobre 2012

Date di iscrizione allo studio

Primo inviato

19 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

26 marzo 2012

Primo Inserito (Stima)

29 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 dicembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PPO 09-283
  • 200910778 (Altro identificatore: University of Iowa)

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 .

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