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Usefulness of Integrative Medicine Tools As Adjunctive Care for Women After Coronary Artery Bypass Grafting

2014年1月27日 更新者:Erin L Olivo PhD, MPH、Columbia University

A Randomized Controlled Trial to Assess the Usefulness of Integrative Medicine Tools As Adjunctive Care for Women After Coronary Artery Bypass Grafting

Background: This randomized controlled trial investigates the effectiveness of an Integrative Therapies (IT) health education intervention in improving physical and psychological functioning in female patients after coronary artery bypass graft (CABG).

Methods: One hundred female cardiac surgery patients were assigned to either an intervention or standard care control group. Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement and were assessed at 6 weeks and 6 months post surgery to determine between group differences on physical functioning and psychological distress using the SF-36 and the Profile of Mood States

調査の概要

詳細な説明

Coronary artery disease is the most frequent cause of death for women in the United States. Increasingly coronary artery bypass graft (CABG) surgery is used for women as a treatment for this disease and women now account for nearly 30% of patients undergoing CABG surgery. Women are reported to have higher morbidity and mortality after CABG surgery than men. In addition to this higher complication and death rate, recent studies suggest that women experience more fear, stress, depression and anxiety before and after surgery than men. This randomized, controlled study was developed to research the feasibility and possible effects of providing health education and complementary and alternative medicine (CAM) tools to women after they have undergone cardiac surgery.

This study is a randomized controlled clinical trial of 150 women from the Columbia campus of New York Presbyterian Hospital who recently had cardiac surgery. Baseline information on risk factor status, psychosocial status, quality of life, and CAM usage and expectancy will be obtained on all participants. Women will be randomized to CAM health education or standard care and will be followed for 6 months. Patients randomized to CAM health education will receive a three-tiered program in CAM education by a certified or trained practitioner in Yoga, Guided Imagery, and Nutrition. Patients will receive both personalized instruction in use of these CAM therapies and custom-designed instructional material including a:

  1. videotape on cardiac yoga,
  2. a guided imagery audiotape and
  3. a booklet on micronutritional approaches to cardiac care (developed by Dr Oz and the Columbia Integrative Medicine Program)

Women randomized to CAM health education will be contacted at 2, 4, and 6 weeks, 3 months, and 6 months post surgery to assess progress toward reaching prevention goals, their utilization of CAM therapies, and their impact on psychological and physical health. The health educator will problem solve with the patient to overcome barriers toward reaching prevention and CAM goals.

Assessments of the following outcomes will be made at 6 weeks and 6 months post intervention: overall mood as measured by the Profile of Mood States12, perception of stress as measured by a single-item, likert stress scale, psychological and mental health status as measured by the SF36, and the occurrence of major adverse cardiac events (cardiovascular disease death, nonfatal myocardial infarction, myocardial revascularization procedure, stroke, non-coronary arterial revascularization, cardiovascular hospitalizations).

It is hypothesized that the CAM education intervention is a feasible mode of disseminating information and encouraging the use of CAM tools to women post cardiac surgery. It is also hypothesized that the CAM intervention will increase overall mood (POMS), will decrease perceived stress (self report stress score), will increase self report of physical and mental functioning (SF36, PH and MH scales) and will decrease episodes of major adverse cardiac events at 6 months postsurgery.

Data analysis will include evaluation of the following within group outcomes: overall adherence and utilization of CAM tools, overall frequency of use by tool (yoga, guided imagery, dietary changes), time point of initiation of CAM use, frequency of use by demographics (age, ethnicity, surgery type, previous CAM exposure, employment status, marital status), most frequent barriers to use, rate of refusal, rate of dropout. In addition, comparisons of the between group outcomes (Mood, Stress, and Physical and Mental Functioning) will be evaluated.

研究の種類

介入

入学 (実際)

100

段階

  • フェーズ 1

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

    • New York
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center

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

女性

説明

Inclusion Criteria:

  • Female patient
  • Undergoing CABG or Valve Surgery

Exclusion Criteria:

  • Non-English speaking
  • No home 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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Integrative Therapies
Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement
Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement
介入なし:Standard Care
Patients were given no intervention but were contacted at 6 weeks and 6 months for data collection purposes

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
時間枠
Self reported psychosocial adjustment
時間枠:6 weeks and 6 months post surgery
6 weeks and 6 months post surgery

二次結果の測定

結果測定
時間枠
Self reported physical functioning and clinical cardiovascular outcomes
時間枠:6 weeks and 6 months post surgery
6 weeks and 6 months post surgery

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

捜査官

  • 主任研究者:Erin L Olivo, PhD, MPH、Columbia University
  • スタディチェア:Mehmet C Oz, MD、Columbia University

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

2004年2月1日

研究の完了 (実際)

2007年12月1日

試験登録日

最初に提出

2009年11月23日

QC基準を満たした最初の提出物

2009年11月24日

最初の投稿 (見積もり)

2009年11月25日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年1月29日

QC基準を満たした最後の更新が送信されました

2014年1月27日

最終確認日

2014年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • AAAB1732

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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