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

12 juni 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

12

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52246-2208
        • Iowa City VA Health Care System, Iowa City, IA

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SF-36v Physical Function Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Medewerkers

University of Iowa

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 april 2012

Primaire voltooiing (Werkelijk)

30 juni 2012

Studie voltooiing (Werkelijk)

31 oktober 2012

Studieregistratiedata

Eerst ingediend

19 maart 2012

Eerst ingediend dat voldeed aan de QC-criteria

26 maart 2012

Eerst geplaatst (Schatting)

29 maart 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 december 2018

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2018

Laatst geverifieerd

1 juni 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PPO 09-283
  • 200910778 (Andere identificatie: University of Iowa)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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