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The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease (GRACE)

2015年4月28日 更新者:Jeff C. Huffman, MD、Massachusetts General Hospital

Overall, the investigators aim to recruit 150 subjects during their hospitalization for an acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels of gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline information about health behaviors critical to cardiac health, and obtain baseline measures of symptoms and function. Finally, the investigators will repeat assessments of biomarkers, behavior, and function at 6 months to allow us to assess the impact of gratitude and optimism on these outcomes; the investigators will also have an objective measure of physical activity via accelerometer (step counter) at 6 months.

Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.

Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater reductions in levels of biomarkers associated with negative heart health between 2 weeks and 6 months.

Specific Aim #2 (*primary aim*): To assess the association between gratitude/optimism 2 weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at 6 months.

Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome measure), and greater improvements in self-reported adherence to health behaviors (activity, diet, and medication) between 2 weeks and 6 months.

Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months.

Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater improvements in depression, health-related quality of life, function, cardiac symptoms, and possibly readmissions, between 2 weeks and 6 months.

調査の概要

状態

完了

詳細な説明

Enrollment Patients will be enrolled during their acute admission for an ACS. At this visit, patients will be introduced to the study and given a follow-up study visit at the MGH Heart Center 2 weeks following their ACS. We will also ask them about their physical activity levels in the time before their ACS.

On the date of enrollment, study staff will estimate baseline physical activity using the Stanford 7-day Physical Activity Recall Scale (PAR). Additionally, contact information (address, phone number, email) will be obtained from the subject along with his/her social security number in order to provide a check for compensation.

Initial Evaluation:

After enrollment, subjects will have a visit 2 weeks post-ACS in the MGH Heart Center. Several procedures will occur during this visit.

  1. Baseline assessments. Subjects will complete self-report measures to assess the following:

    • Gratitude will be assessed using the Gratitude Questionnaire-6 (GQ-6). The GQ-6 is a brief, validated six-item measure of dispositional gratitude.
    • Optimism will be measured using the Life Orientation Test-Revised (LOT-R), a short 6-item rating scale.
    • Baseline adherence to health behaviors will be measured using items from the MOS Specific Adherence Scale (SAS) that ask about diet and medication adherence.
    • Baseline medical and functional status will be measured using the MOS Short Form-12 (SF-12). The SF-12 is a cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study, and the Duke Activity Symptom Index (DASI) for function.
    • Depression will be measured using the Patient Health Questionnaire-9,which is a 9-item scale.
    • Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A is a 7-item scale.
  2. Biomarker collection. Subjects will also have a single blood draw (2 tablespoons or 10 ml/cc) for the following biological factors that are important to cardiac health and may be modified by psychological states. A total of 15 ml/cc of blood will be drawn.
  3. Chart review for baseline variables. We will review subjects electronic medical record to gather data on sociodemographic variables (age, gender), medical information (severity of initial ACS), and overall cardiac function.

3 month phone call:

Three months after enrolling in the study, we will call participants to help them test the accelerometer. We will also schedule their 6-month study visit and repeat all self-report measures. Finally, we will remind them to wear the accelerometer for 14 days prior to their 6-month visit and record their physical activity each day for 14 days. We will schedule this call at a convenient time for the participant (on a weekday, weeknight, or weekend).

Provision of accelerometer:

One month before their six-month visit, we will mail the Pebble uniaxial accelerometer (Fitlinxx, Shelton, CT) to the participant, along with an instruction sheet and technical support contact information. We will contact subjects shortly after to make sure the accelerometer arrived, and we will have them wear the devices for several days to ensure that there are no troubles with fit, operation, or remembering to use the devices.

6 month assessment:

Finally, subjects will return to the MGH Heart Center Clinic 6 months post-ACS. At this assessment, we will repeat all self-report measures, collect accelerometers, draw blood (2 tablespoons or 10 ml/cc) for biomarkers, and inquire about readmissions since enrollment. We will gather additional information about readmissions from participants' physicians and medical records for this exploratory outcome.

研究の種類

観察的

入学 (実際)

212

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

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital

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

サンプリング方法

非確率サンプル

調査対象母集団

Patients admitted to the Ellison Cardiac Care Units at Massachusetts General Hospital.

説明

Inclusion Criteria:

  • Adult patients admitted to cardiac units at MGH with a primary admission diagnosis of ACS (eligible patients must meet World Health Organization criteria for myocardial infarction or criteria for unstable angina [new-onset angina within 2 months, exacerbation of previous angina with rest pain or with minimal exercise, or angina within 2 weeks of MI]). ACS diagnosis will be clarified with the inpatient care team and adjudicated by co-investigator cardiologist Dr. Januzzi as needed.

Exclusion Criteria:

  • 'Periprocedural' ACS (ACS that occurs in the setting of another medical procedure; such events may occur in the absence of structural heart disease and likely represent a different pathophysiology, course and prognosis than those with 'endogenous' ACS).
  • Conditions likely to alter biomarkers of interest (renal failure requiring hemodialysis, inflammatory disease [e.g., systemic lupus erythematosus])
  • Condition likely to lead to death within 6 months (e.g. cancer).
  • Inability to complete physical activity due to unrelated medical condition (e.g., severe arthritis)
  • Inability to complete self-report evaluations due to inability to speak or write in English or due to cognitive deficits (assessed using an established six-item screen).

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

コホートと介入

グループ/コホート
Enrolling by invitation

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
Physical Activity
時間枠:Intake and 6 months after ACS
Subjects' level of physical activity as measured by an activity recall log and number of steps taken over a two week period measured by an accelerometer.
Intake and 6 months after ACS

二次結果の測定

結果測定
メジャーの説明
時間枠
Biomarkers
時間枠:2 weeks and 6 months after ACS
Levels of inflammation (IL-6, hsCRP, sCAM-1, TNF-α) and overall cardiac prognosis (NT-proBNP)
2 weeks and 6 months after ACS
Readmissions (cardiac and all-cause)
時間枠:6 months after ACS
Non-elective readmissions for cardiac and all causes, ascertained by patient report, report of medical providers, and review of medical records.
6 months after ACS

その他の成果指標

結果測定
メジャーの説明
時間枠
Depression
時間枠:2 weeks, 3 months, and 6 months
Patient Health Questionnaire-9 (PHQ-9)
2 weeks, 3 months, and 6 months
Anxiety
時間枠:2 weeks, 3 months, and 6 months
Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)
2 weeks, 3 months, and 6 months
Health-Related Quality of Life
時間枠:2 weeks, 3 months, and 6 months
MOS Short Form-12 (SF-12)
2 weeks, 3 months, and 6 months
Function
時間枠:2 weeks, 3 months, and 6 months
Duke Activity Symptom Index (DASI)
2 weeks, 3 months, and 6 months
Cardiac Symptoms
時間枠:2 weeks, 3 months, and 6 months
A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study
2 weeks, 3 months, and 6 months
Adherence to Medical Recommendations
時間枠:2 weeks, 3 months, and 6 months
The MOS Specific Adherence Scale (SAS)
2 weeks, 3 months, and 6 months

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。

捜査官

  • 主任研究者:Jeff Huffman, M.D.、Massachusetts General Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2012年9月1日

一次修了 (実際)

2014年8月1日

研究の完了 (実際)

2014年8月1日

試験登録日

最初に提出

2012年9月21日

QC基準を満たした最初の提出物

2012年10月16日

最初の投稿 (見積もり)

2012年10月18日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年4月29日

QC基準を満たした最後の更新が送信されました

2015年4月28日

最終確認日

2015年3月1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。

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