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

27. januar 2014 opdateret af: 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

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female patient
  • Undergoing CABG or Valve Surgery

Exclusion Criteria:

  • Non-English speaking
  • No home phone

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Ingen indgriben: Standard Care
Patients were given no intervention but were contacted at 6 weeks and 6 months for data collection purposes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Self reported psychosocial adjustment
Tidsramme: 6 weeks and 6 months post surgery
6 weeks and 6 months post surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Self reported physical functioning and clinical cardiovascular outcomes
Tidsramme: 6 weeks and 6 months post surgery
6 weeks and 6 months post surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Erin L Olivo, PhD, MPH, Columbia University
  • Studiestol: Mehmet C Oz, MD, Columbia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2004

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

23. november 2009

Først indsendt, der opfyldte QC-kriterier

24. november 2009

Først opslået (Skøn)

25. november 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAAB1732

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med Integrative Therapies Intervention

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