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

2018年6月12日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

12

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Iowa
      • Iowa City、Iowa、アメリカ、52246-2208
        • Iowa City VA Health Care System, Iowa City, IA

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
介入なし：Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
SF-36v Physical Function Scale
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

VA Office of Research and Development

協力者

University of Iowa

捜査官

  • 主任研究者：Mark W Vander Weg, PhD MS BA、Iowa City VA Health Care System, Iowa City, IA

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年4月30日

一次修了 (実際)

2012年6月30日

研究の完了 (実際)

2012年10月31日

試験登録日

最初に提出

2012年3月19日

QC基準を満たした最初の提出物

2012年3月26日

最初の投稿 (見積もり)

2012年3月29日

学習記録の更新

投稿された最後の更新 (実際)

2018年12月24日

QC基準を満たした最後の更新が送信されました

2018年6月12日

最終確認日

2018年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PPO 09-283
  • 200910778 (その他の識別子：University of Iowa)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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