- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01566214
Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)
12. Juni 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
12
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
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.
|
Kein Eingriff: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
SF-36v Physical Function Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline to 3-months post hospital discharge
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. April 2012
Primärer Abschluss (Tatsächlich)
30. Juni 2012
Studienabschluss (Tatsächlich)
31. Oktober 2012
Studienanmeldedaten
Zuerst eingereicht
19. März 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. März 2012
Zuerst gepostet (Schätzen)
29. März 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Dezember 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juni 2018
Zuletzt verifiziert
1. Juni 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PPO 09-283
- 200910778 (Andere Kennung: University of Iowa)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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