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

28. dubna 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

212

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Enrolling by invitation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical Activity
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Biomarkers
Časové okno: 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)
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Depression
Časové okno: 2 weeks, 3 months, and 6 months
Patient Health Questionnaire-9 (PHQ-9)
2 weeks, 3 months, and 6 months
Anxiety
Časové okno: 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
Časové okno: 2 weeks, 3 months, and 6 months
MOS Short Form-12 (SF-12)
2 weeks, 3 months, and 6 months
Function
Časové okno: 2 weeks, 3 months, and 6 months
Duke Activity Symptom Index (DASI)
2 weeks, 3 months, and 6 months
Cardiac Symptoms
Časové okno: 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
Časové okno: 2 weeks, 3 months, and 6 months
The MOS Specific Adherence Scale (SAS)
2 weeks, 3 months, and 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jeff Huffman, M.D., Massachusetts General Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2012

Primární dokončení (Aktuální)

1. srpna 2014

Dokončení studie (Aktuální)

1. srpna 2014

Termíny zápisu do studia

První předloženo

21. září 2012

První předloženo, které splnilo kritéria kontroly kvality

16. října 2012

První zveřejněno (Odhad)

18. října 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

29. dubna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2015

Naposledy ověřeno

1. března 2015

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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