- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315834
Couples Coping With Coronary Heart Disease (psychocardio)
The Contribution of Personality Traits to Marital Satisfaction, Well Being and Physical Health in Couples Coping With Coronary Heart Disease Versus a Control Group
Study Overview
Status
Conditions
Detailed Description
Heart disease is the world's leading cause of death in most industrial countries and it requires drastic changes in the lifestyle of the patient. Research on social support and coping with stress has repeatedly shown that being in a supportive spousal relationship has a significant effect on the recovery from a heart disease through alterations in mood, as well as through health habits. However, there are interpersonal differences in the abilities to receive and to provide support. Most of the literature to date has focused either on the experiences of the support recipient or on the support provider; much less research has taken both partners' characteristics into consideration (Revenson & DeLongis, 2011).
The current research aims to broaden the understanding of spousal support among couples coping with a life threatening illness- Coronary Heart Disease (CHD) versus general population of couples. Two studies were designed. Study 1(control group) will focus on general population of couples and its goal is examine the contribution of personality traits of the couples to their marital satisfaction and well-being. Study 2 (target group) will focus on couples coping with a first acute coronary heart disease and its goal is to examine the contribution of personality traits of the couples to their marital satisfaction and well-being, and to health promoting behaviors (smoking cessation, medication adherence) and physical recovery (change in body mass index, change in cholesterol levels) of the ill partners.
The proposed research is a prospective, longitudinal study. The control group will be 100 couples who are not coping with a life threatening illness. The couples will complete self report questionnaires. The target group will be 127 male patients and their partners. The couples will be recruited during the patients' first hospitalization for ACS. The participants will complete questionnaires during the hospitalization and again six months later. Relevant data will be obtained from their medical files.
This study's findings could inform clinicians whose goal is to foster better patient-spouse dynamics in the context of major medical stressors. Helping couples master the challenge of providing and receiving support in such trying times may contribute to enhanced levels of adherence among patients which, in turn, would lead to improved health and saved lives.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Kefar Saba, Israel
- Recruiting
- Department of Cardiology, Meir Medical Center
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Contact:
- Morris Mosseri, Professor
- Phone Number: 972-9-7472587
- Email: Morris.Mosseri@clalit.org.il
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Contact:
- Noa Vilchinsky, Ph.D
- Phone Number: 972-3-531-8601
- Email: noav18@inter.net.il
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Principal Investigator:
- Morris Mosseri, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Jewish men with a Clinical diagnosis of first Acute Coronary Syndrome (ACS: myocardial infarction (MI) or unstable angina (UA))
- Partners also agree to participate in the study
Exclusion Criteria:
- a history of a previous cardiac event
- a diagnosis other than ACS
- co-morbid conditions (such as a severe psychiatric illness, end state renal disease or severe cancer)
- absence of a spouse
- inability to be interviewed in Hebrew
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Couples coping with CHD
The target group will be 127 male patients and their partners.
The couples will be recruited during the patients' first hospitalization for ACS.
The participants will complete questionnaires during the hospitalization and again six months later.
The patients will also be asked to be weighed and have their blood drawn and at the six-month follow-up for measurement of blood Cholesterol level.
Relevant data will be obtained from their medical files.
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control group
The control group will be 100 couples who are not coping with a life threatening illness.
The couples will complete self report questionnaires at one point of time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients' medication adherence
Time Frame: Six months after hospitalization
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Medication adherence: the number of prescriptions filled as a function of the frequency of the medication.
will be obtained from the central database of the patients' HMO.
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Six months after hospitalization
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Change in blood level Cholesterol
Time Frame: six mounths
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Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline from their medical files and at the follow-up patients will be invited again for blood tests.
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six mounths
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Change in body mass index
Time Frame: six-month
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Change in body mass index:Patients' BMI will be measured at baseline and Patients will be asked to weigh in again at the six-month follow-up
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six-month
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Smoking cessation
Time Frame: six months
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Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.
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six months
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Change in blood level Cholesterol
Time Frame: six mounths
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Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline and at the follow-up from their medical files.
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six mounths
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients' and spouses' depression and anxiety symptoms
Time Frame: Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time
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Depression and anxiety- depressive and anxiety symptoms will be measured using the Brief Symptom Inventory [BSI;( Derogatis & Melisaratos, 1983)].
Each participant will be asked to rate the degree to which he has suffered from each symptom during the previous month on a scale ranging from 0 (not at all) to 4 (very much).
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Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time
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Patients' and spouses' marital satisfaction
Time Frame: Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time
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Marital satisfaction - marital satisfaction will be measured using the EMS-ENRICH Marital Satisfaction Scale (Lavee, 1995(.
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Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Morris Mosseri, Professor, Department of Cardiology, Meir Medical Center, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC10psycho-cardioCTIL
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