Usefulness of Integrative Medicine Tools As Adjunctive Care for Women After Coronary Artery Bypass Grafting
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:
- videotape on cardiac yoga,
- a guided imagery audiotape and
- 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
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10032
- Columbia University Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Female patient
- Undergoing CABG or Valve Surgery
Exclusion Criteria:
- Non-English speaking
- No home phone
研究計画
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
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
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。