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

12. juni 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52246-2208
        • Iowa City VA Health Care System, Iowa City, IA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SF-36v Physical Function Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Samarbejdspartnere

University of Iowa

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2012

Primær færdiggørelse (Faktiske)

30. juni 2012

Studieafslutning (Faktiske)

31. oktober 2012

Datoer for studieregistrering

Først indsendt

19. marts 2012

Først indsendt, der opfyldte QC-kriterier

26. marts 2012

Først opslået (Skøn)

29. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PPO 09-283
  • 200910778 (Anden identifikator: University of Iowa)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjerte sygdom

Kliniske forsøg med Motivational Interview

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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